Positive Urine Pregnancy Test Research Articles

P-557 The contribution of PGT-A to PGT-M and PGT-SR clinical outcomes – A single centre retrospective analysis

Abstract Study question To determine if the introduction of concurrent testing with PGT-A has improved clinical outcomes for PGT-M/SR patients. Summary answer This study demonstrates that the introduction of concurrent testing may have improved clinical outcomes for this patient demographic irrespective of age. What is known already Preimplantation Genetic Testing (PGT) is utilised to investigate the genetic constitution of embryos. PGT-M (monogenic) and PGT-SR (structural rearrangements) are screening techniques considered in treatment for couples at risk of conceiving offspring with known genetic or structural chromosomal abnormalities respectively. Preimplantation Genetic testing for Aneuploidy (PGT-A) was developed in order to screen embryos for numerical chromosomal abnormalities, a leading cause of failed implantation. Nevertheless, routine use of PGT-A is discouraged due to lack of evidence regarding its efficacy. However, PGT-A is routinely used alongside PGT-M and PGT-SR despite the lack of evidence of its effectiveness in improving patient outcomes. Study design, size, duration The retrospective analysis of 496 PGT-M/SR single embryo transfer patient cycles between December 2013 and December 2021. Participants/materials, setting, methods The retrospective analysis of 496 PGT-M/SR single embryo transfer cycles at CRGH Portland was undertaken (single testing n = 77; concurrent testing n = 419). The clinical outcomes (positive urine pregnancy test, clinical pregnancy, live birth and miscarriage rates) were compared between groups using IBM SPSS Statistics (premium 27). Binary logistic regression was performed for statistical analysis, results with p < 0.05 were determined statistically significant. Main results and the role of chance Overall, concurrent testing was associated with statistically significant improved clinical outcomes compared to the reference group. Statistical significance was seen in positive urine pregnancy test (49% vs 68%, p = 0.012), clinical pregnancy (32.5% vs 63%; p = 0.000013), live birth rate (32.5% vs 59%; p = <0.00016) and miscarriage rates (34.2% vs 13%; p = 0.001). The results imply that the introduction of concurrent testing has improved the probability of obtaining a positive clinical outcome and has reduced the chance of miscarriage in this patient demographic. Further analysis showed concurrent testing improved the chances of obtaining a positive clinical outcome irrespective of the patients age or quality of the embryo. Limitations, reasons for caution This study has produced promising results. However, there are several limitations such as the small sample size, embryo biopsy techniques used, and the different molecular diagnostic techniques and providers utilised. Wider implications of the findings The results imply a justification for the use of PGT-A alongside PGT-M/SR screening techniques to improve embryo selection and clinical outcomes for this cohort of patients. Additionally, they demonstrate the efficacy of PGT-A in a previously underrepresented demographic. However, further research is required to confirm the clinical value of PGT-A. Trial registration number not applicable

Emergency contraception for individuals weighing 80 kg or greater: A randomized trial of 30 mg ulipristal acetate and 1.5 mg or 3.0 mg levonorgestrel

ObjectiveTo compare the efficacy of oral emergency contraception (EC) regimens used within 72 hours of unprotected intercourse in individuals weighing >80 kg. Study DesignWe enrolled healthy women aged 18-40 years with a weight of at least 80 kg requesting EC in a multi-center, single-blind, randomized study of levonorgestrel 1.5 mg (LNG1X) and 3.0 mg (LNG2X) and ulipristal acetate 30 mg (UPA) (enrollment goal 1200). Key eligibility requirements included regular cycles, unprotected intercourse within 72 hours of enrollment, no use of hormonal contraception since last menstrual period, a negative urine pregnancy test (UPT), and willingness to abstain from intercourse until next menses. Study staff directly observed EC ingestion. To assess our primary outcome of incidence of pregnancy, participants completed home UPTs; if no menses by 2-weeks post-treatment, or a positive UPT, they returned for an in person visit with quantitative serum human chorionic gonadotropin (hCG) and ultrasound. ResultsWe enrolled and randomized 532; 44 were not dosed or not evaluable for primary end-point, leaving an analyzable sample of 488 (173 LNG1X, 158 LNG2X, 157 UPA) with similar demographics between groups [mean age 29.6 years (5.74), BMI 37.09 kg/m2 (6.95)]. Five pregnancies occurred during the study (LNG1X n = 1, LNG2X n = 1, UPA n = 3); none occurred during the highest at-risk window relative to estimated day of ovulation (day of ovulation and the 3 days prior). We closed the study prior to achieving our enrollment goal because the low pregnancy rate in all groups established futility based on an interim blinded analysis. ConclusionAlthough slow enrollment limited our study power, we found no differences in pregnancy rates between oral EC regimens among women weighing 80 kg or more. Our results are not able to refute or support differences between the three treatment arms. ImplicationsWomen weighing 80 kg or more experienced no differences in pregnancy rates between oral EC regimens but due to several significant study limitations including sample size and the lack of a study population at high risk of pregnancy, our results are not able to determine if differences in treatment effectiveness exist.

Successful pregnancy outcome via in-vitro fertilization and laparoscopic resection of non-communicating rudimentary horn pregnancy containing early pregnancy: a case report

BackgroundNon-communicating rudimentary horn pregnancy (NCRHP) lead to life-threatening condition for both mother and fetus. Early diagnosis of NCRHP and laparoscopic resection is important to prevent catastrophic conditions. However, delayed diagnosis until the second or third trimester makes it difficult to accurately diagnose between NCRHP and bicornuate uterine pregnancy, as both conditions present uterine rupture and massive hemoperitoneum. Furthermore, these rare cases are challenging in pregnancy trials and associated with adverse outcomes in subsequent pregnancies.Case presentationA 31-year-old gravida 1 para 0 Korean woman visited our infertility center with a confirmed positive urine pregnancy test after timed intercourse. Before she was scheduled to have timed intercourse, a unicornuate uterus with a non-communicating right uterine horn was suspected based on an ultrasound scan and hysterosalpingography during the initial infertility workup. A gestational sac was observed in the right non-communicating rudimentary horn at 5 weeks of gestation. Serum beta-human chorionic gonadotropin (b-hCG) level was 2052.0mIU/mL. An elective laparoscopic resection of the right rudimentary horn containing a gestational sac, along with ipsilateral salpingectomy, was performed with no adverse event. After 3-month of recovery period and three cycles of conceptional trials involving timed intercourse and intrauterine insemination, in-vitro fertilization (IVF) was performed using the antagonist protocol, and successful pregnancy was confirmed. The patient had been hospitalized from 21 + 6 weeks to 35 + 6 weeks of gestation, underwent cerclage placement and tocolytics with corticosteroid treatment. She delivered an early-term male baby by cesarean section.ConclusionIn this rare case, the successful pregnancy achieved through IVF following the appropriate management of NCRHP under laparoscopy underscores the critical importance of early diagnosis and intervention in cases of NCRHP. Timely identification and management of NCRHP are vital to prevent the occurrence of catastrophic conditions and to enhance the prognosis of a successful pregnancy through assisted reproductive technology (ART). Therefore, a high index of suspicion for NCRHP is important and employs a range of diagnostic modalities.

SAT129 Clinical Conundrum Of Suspected Pancreatitis Masking Diabetic Ketoacidosis

Abstract Disclosure: A. Sood: None. O. Syed: None. A. Sood: None. P. Patel: None. M.M. Alosiyus: None. ​​Abstract: Patients with End-Stage-Renal-Disease (ESRD) have poor renal excretion which can cause false elevation in pancreatic enzymes. We present a case of a pregnant woman on hemodialysis (HD) with elevated lipase levels concerning for acute pancreatitis. Case Presentation: A 25-year-old African American female with history of type 1 diabetes mellitus, ESRD secondary to diabetic nephropathy, diabetic gastroparesis, hypertension presented to the hospital with diffuse severe abdominal pain following HD. Lab showed Anion gap 15, Glucose 304 mg/dL, Creatinine 4.6 mg/dL, Triglyceride 130 mg/dL, Lipase 390 mg/dL, with urine negative for ketones. The abdominal US was negative for gallstones, and revealed a normal size common bile duct. CT scan was deferred due to a positive urine pregnancy test. She was started on IV fluids for suspected pancreatitis. Patient had worsening blood glucose levels as well as anion gap despite being on Humalog and correctional scale insulin. Patient was started on an insulin drip with resolution of the anion gap. Discussion: Patient met 2 of 3 criteria for pancreatitis, with CT and MRI deferred in this case due to pregnancy and low suspicion secondary to negative US result.[5] Pancreatic enzymes can be falsely elevated in ESRD patients. Lipase can be elevated in HD[3] patients due to the lipolytic effect of heparin used during dialysis, while elevation of lipase in DKA remains unclear[2]. Acidosis is common in ESRD patients, thus masking the diagnosis of DKA which also presents with abdominal pain, nausea, vomiting, which can potentially cause a delay in the treatment. The mimicking and masking of these conditions by each other can thereby result in a diagnostic dilemma, which is why a prompt diagnosis of pancreatitis should be made in a patient presenting with DKA. Conclusion: Elevated levels of amylase and lipase are concerning for pancreatitis, however, metabolic processes could also be masked by underlying chronic diseases. While fluid resuscitation is the mainstay treatment for DKA and pancreatitis, it is extremely important to be cautious when a patient has an underlying ESRD. The diagnostic dilemma due to the overlapping diagnosis should be taken into consideration early during the hospitalization, and a high index of clinical suspicion can prevent the unnecessary delay in the treatment.

Mediterranean Diet Adherence and Depressive Symptoms among a Nationally Representative Sample of Pregnant Women in the United States

BackgroundPrenatal depression affects ∼12% of pregnant women in the United States and is associated with an increased risk of adverse birth outcomes and maternal mortality. Adherence to a healthy dietary pattern may reduce and/or protect against depressive symptoms. ObjectivesTo investigate the relationship between adherence to a Mediterranean diet and depressive symptoms among pregnant women in the United States. MethodsWe used data from the National Health and Nutrition Examination Survey (2005–2018, N = 540) and included pregnant women aged 18–44 y with a positive urine pregnancy test. The Mediterranean diet score (aMED) was calculated from 1 24-h recall; aMED typically ranges from 0–9, but in these analyses, it ranged from 0–8 because alcohol was not included. The aMED score was dichotomized as high (>3) compared with low (≤3). The Patient Health Questionnaire-9 (PHQ-9), which measures depressive symptoms, was dichotomized as lower compared with higher (PHQ-9 score ≥10), based on the clinical cutoff for patient referral. Our primary model employed logistic regression to investigate the association between aMED adherence and high depressive symptoms when controlling for socio-demographics (age, racial/ethnicity, education, poverty, and relationship status), total calories, and prepregnancy body mass index (kg/m2). We also modeled the PHQ-9 score as a continuous variable using a random-effects model. ResultsAbout 5% of pregnant women had moderate to severe depressive symptoms, and 45% were highly adherent to a Mediterranean diet. Higher adherence to a Mediterranean diet was associated with lower odds of depressive symptoms (odds ratio: 0.31, 95% confidence interval: 0.10, 0.98). Results were not significant for the continuous PHQ-9 score (β: –0.30; 95% confidence interval: –0.90, 0.30). ConclusionsAdherence to a Mediterranean diet may have the potential to lower depressive symptoms among pregnant women; however, these results should be interpreted with caution. Nevertheless, considering the public health significance of promoting mental wellness among pregnant women, this relationship merits further examination using experimental designs.

Effect of hyaluronic acid-enriched transfer medium on frozen-thawed embryo transfer outcomes in RIF patients: a single-centre retrospective study.

Many patients who undergo assisted reproductive technology (ART) suffer from recurrent implantation failure (RIF). The addition of hyaluronic acid (HA) to the transfer medium is one of several methods to improve pregnancy outcomes. We investigated whether HA could improve the live birth and clinical pregnancy rates of RIF patients. This study included 248 RIF patients, who were divided into two groups: the control (CTL) group (n=137), which received transfer medium without HA, and the HA group (n=111), which received transfer medium with HA. The two groups were compared according to the ART outcome. The primary outcomes were the clinical pregnancy and live birth rates. Secondary outcomes include a positive urine pregnancy test, the implantation, ongoing pregnancy, multiple pregnancy, clinical miscarriage, and ectopic pregnancy rates, foetal or congenital defects, obstetric complications, infant birth weight and any related adverse events. Regarding the primary outcomes, the clinical pregnancy rate was significantly higher in the HA group than in the control group, and there was no significant difference in the live birth rate (LBR) between the HA and control groups. Regarding the secondary outcomes, the implantation, multiple pregnancy and ectopic pregnancy rates were similar between the two groups. Our findings supported the conclusion that HA can improve the clinical pregnancy rate of patients with RIF undergoing FET cycles, but the live birth rate was not significantly improved with the addition of HA to the traditional transfer medium.

P-652 RCT to evaluate the necessity of routine luteal phase support after ovarian stimulation by oral ovulogens in intrauterine insemination (IUI) cycles

Abstract Study question 1. Is it beneficial to provide luteal phase support in each IUI cycle stimulated by oral ovulogens ? Summary answer 1. Luteal phase support with progesterone makes no significant difference in clinical pregnancy rate in oral ovulogen stimulated IUI cycles. What is known already ART (assisted reproductive techniques) involves superovulation to achieve the development of multiple follicles. This produces supraphysiological E2 levels that causes feedback inhibition of FSH and LH in luteal phase leading to luteal phase defect. In IUI,only few follicles develop ,so the above phenomenon is rarely seen. Today widespread use of progesterone in clinical practice has become a habit, instead of the need, adding to burden of medication and cost to the patient without much evidence to recommend it. Study design, size, duration Prospective Randomized control over 1 year 200 IUI cycles randomized to either supplementing luteal phase with tab dydrogesterone (Group A ,no.100) or not supplementing (Group B, No. 100) as per inclusion(Unexplained infertility,Mild male factor,Donor sperm IUI, PCOD,Coital factors,Mild endometriosis) and exclusion criteria(IUI with gonatotropin, age more than 38 years, thin endometrium ,previous two or more IUI failures, history suggestive of luteal phase defect, recurrent pregnancy loss, structural uterine anomaly, history of endocrine or autoimmune diseases) Participants/materials, setting, methods Transvaginal scan was conducted on day 2 , followed by ovarian stimulation with letrozole 2.5 mg for 5 days. HCG trigger (10000IU) was given When follicle reached 18- 24mm with endometrium >7mm and IUI timed 36 hours after. Computer generated random allocation was done with one group receiving luteal phase support with tab dydrogesterone 10mg twice a day(Group A)and other not receiving LPS(Group B).Outcome of study was studied in terms of clinical pregnancy on USG. Main results and the role of chance Among the patients recruited, infertility was observed to be primary infertility in 74% cases in Group B and 72% in Group A , whereas secondary infertility was observed in 26% cases in group B and 28% in group A (P = 0.75). Group B included mild male factor in 29%, 24% of polycystic ovarian syndrome, 17 % tubal, 15% poor ovarian reserve, 9% of unexplained and 6% had endometriosis. Whereas in group A, PCOS (25%),male factor (21%),poor ovarian reserve and unexplained in 20%, endometriosis in 8% and 6% had tubal infertility. Among patients, mean endometrium thickness on trigger day of group Band group A were 8.46 ± 1.36mm and 8.44 ± 1.17mm respectively. Conception was reported by a positive urine pregnancy test . Among Group B , 23% had a positive urine pregnancy test. Whereas, in controls Group A 21% had a positive test, the difference being statistically non-significant (p value = 0.733) Outcomes were expressed terms of clinical pregnancy described as the presence of intrauterine sac with foetal heart rate. Clinical pregnancy rate was 22% of group B and 21% in group A , difference was statistically nonsignificant (p = 0.755). Limitations, reasons for caution Due to limited period of study and hence restricted sample size, the trial needs to be extended over a larger sample size for further interpretation. Further subgroup analysis needs to be conducted when a larger study group is recruited. Wider implications of the findings This study suggested that luteal support does not significantly affect the clinical pregnancy rate in IUI cycles with oral ovulogens .Our study could be a basis for further analysis to determine whether treatment burden in the form of luteal phase support can be reduced in such patients. Trial registration number not applicable

O-023 ‘The PiNC Trial’: Progesterone in Natural Cycles for the treatment of unexplained infertility

Abstract Study question Does exogenous progesterone for luteal phase support in natural cycles affect the biochemical, clinical pregnancy, livebirth or miscarriage rates in women with unexplained infertility (UI)? Summary answer Progesterone luteal support lead to an increase in livebirth rate from 7% to 15.3% and a decrease in miscarriage rates from 40% to 20%. What is known already Unexplained infertility is a diagnosis likely to encompass a population with varying underlying subtle pathologies. The only treatments currently recommended for treating UI are intrauterine insemination (IUI) and IVF/ICSI which are both expensive and invasive. The evidence for IUI with and without controlled ovarian hyperstimulation (COH) is inconclusive. A recent systematic review and meta-analysis reported a progesterone-mediated reduction in endometrial receptivity as a possible mechanism in the pathogenesis of UI. No trial has been published investigating the effectiveness of exogenous progesterone for luteal support in otherwise natural, unmedicated cycles to improve reproductive outcomes in couples with UI. Study design, size, duration We conducted an open-label, parallel arm, single centre, randomised controlled trial of an investigational medicinal product (cTIMP) from February 2020 to November 2022. We randomised 143 couples with UI to either luteal phase progesterone support or no luteal phase support and analysed the results on an intention-to-treat basis. Each couple participated for 3 menstrual cycles and they were followed up until either the end of a 3rd non-conceptual cycle or any resulting pregnancy. Participants/materials, setting, methods Couples with normal semen analysis (WHO 2020), regular ovulation, bilateral patent tubes, female partner aged ≤42yrs and BMI ≤30 were recruited and randomised following screening and informed consent. Participants timed their luteinising hormone (LH) surge using digital ovulation kits and had timed intercourse for 3 cycles. The treatment group took progesterone suppositories 400mg bd for 14 days after the LH surge. All pregnancies were scanned at 6-7/40 and ongoing pregnancies followed up to delivery. Main results and the role of chance 143 couples were recruited and randomised. Livebirth rates were 11/72 (15.3%) in the treatment group vs. 5/71 (7.0%) in the control group (Odds Ratio (OR) 2.38, 95%CI 0.78-7.24). Biochemical pregnancy rates (defined by a positive urinary pregnancy test) were 15/72 (20.8%) (treatment) vs 10/71 (14.1%) (control) (OR 1.61, 95%CI 0.67-3.86). Clinical pregnancy rates (defined by a gestation sac seen on ultrasound at a minimum of 6/40 gestation) were 14/72 (19.4%) (treatment) vs 9/71 (12.7%) (control) (OR 1.66, 95% CI 0.67-4.13). The miscarriage rate including biochemical losses was 3/15 (20%) of all pregnancies (treatment) vs. 4/10 (40%) (control). One pregnancy in the control group was terminated due to fetal anomalies. There was one ectopic pregnancy in the treatment group. Logistic regression demonstrated that none of the pregnancy outcomes were affected by participant age, BMI, ovarian reserve markers, previous parity or semen analysis parameters. The two participants in the treatment group who experienced miscarriages were both off-protocol. Although the results did not reach statistical significance, the 15.3% livebirth rate and OR of 2.37 for livebirths are clinically significant (equivalent to the success rates of stimulated intrauterine insemination treatment) as is the miscarriage rate of 0/11 clinical intra-uterine pregnancies for women taking progesterone as per protocol.Limitations, reasons for caution Despite the lack of statistical significance, differences in livebirth and miscarriage rates are clinically significant compared with alternative treatments. The trial was unblinded but the objective outcomes are unlikely to be affected by this. A larger trial using the effect size from this study to guide sample size is planned. Wider implications of the findings The treatment investigated here represents a simple, non-invasive and inexpensive option that is acceptable to couples with UI and may increase their chance of pregnancy and livebirth. If this treatment offers similar success rates to stimulated IUI it is likely to become a first-line option for many couple worldwide. Trial registration number 2019-003468-27

Heparin for women with recurrent miscarriage and inherited thrombophilia (ALIFE2): an international open-label, randomised controlled trial

Anticoagulant therapy might reduce the number of miscarriages and adverse pregnancy outcomes in women with recurrent pregnancy loss and inherited thrombophilia. We aimed to assess use of low-molecular-weight heparin (LMWH) versus standard care in this population. The ALIFE2 trial was an international open-label, randomised controlled trial undertaken in hospitals in the UK (n=26), the Netherlands (n=10), the USA (n=2), Belgium (n=1), and Slovenia (n=1). Women aged 18-42 years who had two or more pregnancy losses and confirmed inherited thrombophilia, and who were trying to conceive or were already pregnant (≤7 weeks' gestation), were eligible for inclusion. Women were randomly assigned (1:1) to use low-dose LMWH or not (alongside standard care in both groups) once they had a positive urine pregnancy test. LMWH was started at or before 7 weeks' gestation and continued until the end of pregnancy. The primary outcome measure was livebirth rate, assessed in all women with available data. Safety outcomes included bleeding episodes, thrombocytopenia, and skin reactions, and were assessed in all randomly assigned women who reported a safety event. The trial was registered within the Dutch Trial Register (NTR3361) and EudraCT (UK: 2015-002357-35). Between Aug 1, 2012, and Jan 30, 2021, 10 625 women were assessed for eligibility, 428 were registered, and 326 conceived and were randomly assigned (164 to LMWH and 162 to standard care). 116 (72%) of 162 women with primary outcome data in the LMWH group and 112 (71%) of 158 in the standard care group had livebirths (adjusted odds ratio 1·08, 95% CI 0·65 to 1·78; absolute risk difference, 0·7%, 95% CI -9·2% to 10·6%). 39 (24%) of 164 women in the LMWH group and 37 (23%) of 162 women in the standard care group reported adverse events. LMWH did not result in higher livebirth rates in women who had two or more pregnancy losses and confirmed inherited thrombophilia. We do not advise use of LMWH in women with recurrent pregnancy loss and inherited thrombophilia, and we advise against screening for inherited thrombophilia in women with recurrent pregnancy loss. National Institute for Health and Care Research and the Netherlands Organization for Health Research and Development.

EFFECT OF AGE AND BMI ON PREGNANCY OUTCOME IN PATIENTS UNDERGOING IUI

Introduction: Intrauterine insemination (IUI) is the rst line of assisted conception method, which has been widely used for the treatment of subfertility couples. It is a technique in which the semen is processed into highly concentrated motile sperm and inseminated into the uterus through the cervix using a ne catheter. It is often suggested to infertile couples of which the woman has at least one patent fallopian tube. Many prognostic factors are associated with successful pregnancy in IUI cycles e.g., younger female age, higher total motile sperm per ejaculate, better ovarian reserve, and more number of dominant follicles. The present study aims to study the inuence of female's age and body mass index on pregnancy rates following IUI procedure. This retros Methodology: pective observational study was done from June 2021 to June 2022 on 60 couples who underwent IUI at KVGMCH, sullia. The patients included in the study were aging between 19- 45 years. Weights and heights of women were recorded and BMI was calculated. They were classied into 4 BMI categories. The IUI procedure was carried out and pregnancy outcome was measured as positive urine pregnancy test. The overall pregnancy rate after IUI in the study Results: group was 15%. Highest pregnancy rate of 18.75%, was observed in the age group of 31-35 years, as compared with 10% pregnancy rate among 41-45 years. However this difference was not statistically signicant (p-0.9877),one pregnancy occurred at 42 years among 10 women over 41 years of age, whereas 3 pregnancy occurred among 16couples. BMI was calculated and tabulated according to WHO denition. The highest pregnancy rate was observed as 20% for BMI >/ 35, while the lowest pregnancy rate was 12.5% with the BMI from 18.5 to 25.5. This difference was also not statistically signicant( p-0.96992). Conclusion: The study concludes that IUI improves the chances of pregnancy in unexplained infertility. The efcacy of IUI is highest in middle age and efciency declines after the age of 45years. Pregnancy outcome is independent of BMI of women

Medication abortion and uterine aspiration for undesired pregnancy of unknown location: A retrospective cohort study

ObjectiveTo compare days to diagnosis of pregnancy location for same-day medication abortion and same-day uterine aspiration with delayed treatment (expectant management) in patients with undesired pregnancy of unknown location (PUL). Study designWe conducted a retrospective cohort study at a single Planned Parenthood health center in Minnesota. We reviewed electronic health records and included patients presenting for induced abortion diagnosed with PUL (positive high-sensitivity urine pregnancy test and no evidence of intrauterine or extrauterine pregnancy on transvaginal ultrasonography) without symptoms or ultrasonographic imaging concerning for ectopic pregnancy (low risk). The primary outcome was days to pregnancy location clinical diagnosis. ResultsOf 19,151 abortion encounters in 2016–2019, 501 (2.6%) had a low-risk PUL. Participants chose delay-for-diagnosis before treatment (148, 29.5%), immediate treatment medication abortion (244, 48.7%), or immediate treatment uterine aspiration (109, 21.8%). Median days to diagnosis were significantly lower in the immediate treatment uterine aspiration group (2 days, IQR 1–3 days, p < 0.001) and similar for immediate treatment medication abortion (4 days, IQR 3–9 days, p = 0.304) compared with delay-for-diagnosis (3 days, IQR 2–10 days). Thirty-three low-risk participants (6.6%) were treated for ectopic pregnancy, but no difference in ectopic rate was detected among groups (p = 0.725). Participants in the delay-for-diagnosis group were more likely to be nonadherent with follow-up (p < 0.001). For participants who completed follow-up, abortion completion rate was lower for immediate treatment medication abortion (85.2%) compared with immediate treatment uterine aspiration (97.6%, p = 0.003). ConclusionsFor patients with undesired PUL, diagnosis of pregnancy location was fastest with immediate treatment uterine aspiration and similar for expectant management and immediate treatment medication abortion. Medication abortion efficacy may be reduced in treatment of undesired PUL. ImplicationsFor PUL patients desiring induced abortion, the option of proceeding at initial encounter may help improve access and patient satisfaction. Uterine aspiration for PUL may help diagnose pregnancy location more quickly.

A Positive Urine Pregnancy Test Leads to a Diagnosis of Primary Gastric Choriocarcinoma: Describing a Diagnostic Dilemma

A Positive Urine Pregnancy Test Leads to a Diagnosis of Primary Gastric Choriocarcinoma: Describing a Diagnostic Dilemma

Low-Molecular-Weight Heparin Versus Standard Pregnancy Care for Women with Recurrent Miscarriage and Inherited Thrombophilia (ALIFE2): An Open-Label, Phase III Randomized Controlled Trial

Background Studies have shown an association between recurrent miscarriage and inherited thrombophilia. It has been hypothesized that anticoagulant therapy might reduce both number of miscarriages and adverse pregnancy outcomes in these women and this is widely practiced despite lack of solid evidence. In the absence of randomized controlled trials that assess the efficacy of low-molecular-weight heparin (LMWH) therapy in women with recurrent miscarriage and inherited thrombophilia, a randomized clinical trial that addresses this topic was highly needed. Methods Design: The ALIFE 2 trial was an investigator-initiated, international open-label randomized controlled trial. The Netherlands coordinated recruitment in 15 hospitals in the Netherlands, USA, Belgium, and Slovenia. The UK coordinated 26 sites including sites in England, Scotland, Wales and Northern Ireland. The study protocol was approved by the institutional review boards of all participating centres, and in the UK, NRES, MHRA and HRA. Written informed consent was obtained from all patients prior to randomization. The trial was registered within the Dutch Trial Register (NTR3361) and EudraCT (UK: 2015-002357-35). Study population: Women (18-42 years) who had two or more pregnancy losses and confirmed inherited thrombophilia (factor V Leiden, prothrombin 20210A mutation, antithrombin, protein C or protein S deficiency) who were actively trying to conceive or less than 7 weeks pregnant were eligible for inclusion. Women were excluded if duration of current pregnancy was 7 weeks or more, if they had an indication for anticoagulant treatment during pregnancy, a contraindication for LMWH, a known allergy for LMWH or previous enrolment in this trial. Randomisation and intervention: Women were randomly assigned (1:1) to use subcutaneous LMWH once daily (enoxaparin 40 mg, dalteparin 5,000 IU, tinzaparin 4,500 IU or nadroparin 3,800 IU) versus standard pregnancy surveillance once they had a positive urine pregnancy test. LMWH was started ≤ 7 weeks of pregnancy and continued until the end of pregnancy. Outcomes: The primary outcome measure was live birth rate. Secondary outcomes included adverse pregnancy outcomes, such as miscarriage, obstetric complications (premature delivery, pre-eclampsia, HELLP syndrome, intrauterine growth restriction), and congenital malformations. Safety outcomes included bleeding episodes, thrombocytopenia, and skin reactions to the prescribed study medication. Statistical analysis: Analysis includedall available datafrom all women who were randomized and did not withdraw consent to be followed up, as per the intention-to-treat principle. Exploratory subgroup analyses investigated the effect of age, number of previous miscarriages, previous live birth and type of inherited thrombophilia. Results Between August 2012 and January 2021, 10,626 women with recurrent miscarriage were assessed for eligibility, most of whom were not eligible due to absence of inherited thrombophilia. A total of 428 women were registered, of whom 326 women conceived and were randomized. 164 were assigned to the LMWH group and 162 were assigned to the standard surveillance group. The mean age was 33 years, approximately one third being 36 years or older, and the majority was of caucasian ethnicity (83%). The median number of miscarriages prior to randomization was 3, and 70% had a history of 3 or more miscarriages. The most common thrombophilia types were heterozygosity for factor V Leiden (56%), prothrombin 20210A mutation (25%), and protein S deficiency (14%). Aspirin was used as co medication in 11%. Observed live birth rates were 116/162 (71.6%) in the LMWH group and 112/158 (70.9%) in the standard surveillance group (adjusted OR 1.08 (95% CI 0.65 to 1.78)(absolute difference 0.7% (95% CI -9.2% to 10.6%). Adverse events were reported for 39 women (23.8%) in the LMWH group and 37 (22.8%) women in the standard surveillance group. Interpretation Compared with standard surveillance, the use of LMWH did not result in higher live birth rates in women who had two or more pregnancy losses and confirmed inherited thrombophilia. On the basis of our findings, we do not advise routine use of LMWH in women with recurrent pregnancy loss and confirmed inherited thrombophilia, and we advise against routine testing for inherited thrombophilia in women with recurrent pregnancy loss.

Misdiagnosis of gestational trophoblastic neoplasia as ectopic pregnancy: A 15-year retrospective study.

Gestational trophoblastic neoplasia is an uncommon disease, whose clinical manifestations are similar to ectopic pregnancy, thus some rare pelvic lesion can be misdiagnosed as ectopic pregnancy. This study was presented to investigate the characteristics of gestational trophoblastic neoplasia misdiagnosed as ectopic pregnancy and reduce the misdiagnosis. The clinicopathological data for 14 cases of gestational trophoblastic neoplasia misdiagnosed as ectopic pregnancy at West China Second Hospital Sichuan University from January 2006 to December 2020 were retrospectively analyzed. The main clinical manifestations were amenorrhea, abnormal vaginal bleeding, and abdominal pain. At initial diagnosis, the serum hCG level was >10,000 mIU/mL in 5 patients and <10,000 mIU/mL in 7 patients, and a positive urine pregnancy test alone was found in 2 patients. Vaginal ultrasonography showed no abnormalities in 7 cases, adnexal mass in 5 cases, and tubal thickening in 2 cases. The patient's previous pregnancy was an abortion in 7 cases, full-term in 4 cases, and a hydatidiform mole in 3 cases. Clinical stage: 3 cases were stage I, 3 were stage II, 7 were stage III, and 1 case was stage IV (liver and spleen metastases). The median FIGO prognostic score was 13.5 points (12-21 points), with 9 cases having a score >13 points (very high risk). From 14 patients, only 3 had molar pregnancy previously. Only 3 patients had no metastasis at GTN diagnosis (from these 3, only one after molar pregnancy). After chemotherapy alone or in combination with surgery, all patients survived, with a median follow-up of 84 months (23-102 months). If we have positive hCG, without a sonographic topic gestation confirmation, associated with metastatic lesions, the GTN diagnosis should be considered instead of ectopic pregnancy, if the patient have had a pregnancy once during her life.

Efficacy of clomiphene citrate alonecompared with combination of clomiphene citrate and metformin for treatment of infertility in polycystic ovarian syndrome (PCOS).

Objective: To evaluate the efficacy of clomiphene citrate compared with clomiphene citrate and metformin combination used as infertility treatment in polycystic ovarian syndrome. Study Design: Randomized Controlled study. Setting: Combined Military Hospital, Nowshera, KPK. Period: March 2021 to November 2021. Materia &amp; Methods: One hundred and forty egiht infertile patients aged between 20 to 34 years diagnosed with PCOS were enrolled for the investigation. Using blocked randomization technique, the participants were divided into two groups. Group A patients received clomiphene citrate 50 mg day on days 2 to 6 and dose was gradually increasedto 150 mg day. Patients in Group B received metformin 500 mg three times a day along with the above mentioned dosage of clomiphene citrate. Collectively, the patients in both groups were provided with a follow up for six months. Efficacy in both groups was assessed on the basis of positive urine pregnancy test. Results: The rate of ovulation in group B was high in comparison to group A (39.2%vs 21.6%; P value = 0.02) the results were statistically significant. The rate of efficacy/conception in group B was significantly greater as compared to group A (32.4%vs 16.2%; P value = 0.02). Conclusion: We conclude that clomiphene citrate along with met formin, used in combination is significantly much efficacious as compared to clomiphene citrate alone for treatinginfertility in patients with polycystic ovarian syndrome.

STUDY OF FETO-MATERNAL OUTCOME IN PREGNANT WOMEN WITH BLEEDING PER VAGINUM IN FIRST TRIMESTER OF PREGNANCY.

Background: Objective of the study was to study the feto-maternal outcome in patients with bleeding per vaginum in rst trimester of pregnancy. Methods: This prospective observational study was carried out on 110 women attending with history of rst trimester vaginal bleeding at a tertiary health centre Gandhinagar from June 2018 to May 2019 for a period of twelve months. Patients with history of amenorrhea and positive urine pregnancy test with bleeding per vaginum in rst trimester were included. Those Results: patients with bleeding per vaginum in rst trimester and whose pregnancy continued beyond 20 weeks of gestation, had increased rate of maternal and fetal morbidities. First trimester Conclusions: bleeding is signicantly associated with adverse maternal and neonatal outcomes.

P-288 COVID vaccination in women and IVF treatment outcomes

Study questionDoes COVID-19 vaccination (mRNA or viral vector) in women affect outcomes following IVF treatment?Summary answerThere was no difference in both pre-clinical and IVF clinical outcomes in women who received vaccination (1 or 2 doses) compared to those unvaccinated.What is known alreadyThe COVID-19 vaccination rollout has been unprecedented and commenced in the UK in December 2020.Compared to the general population, pregnant women have higher risk of morbidity following COVID-19 infection. There is a drive by public health authorities for women of reproductive age to be vaccinated. However, there has been hesitancy in the uptake of vaccination amongst certain patient populations including those who are trying to conceive.Emerging data has shown that follicular function is unaffected by COVID-19 vaccination, although this data is limited. IVF treatment is unique as we can evaluate both pre-clinical embryological outcomes and clinical outcomes.Study design, size, durationWe conducted a retrospective analysis of 474 women undergoing IVF treatment between Jan and Dec 2021. COVID-19 vaccination status was recorded including: vaccination type, number of vaccine doses, and whether they had previously contracted COVID-19. We recorded pre-clinical and clinical outcomes: such as number of oocytes retrieved, fertilisation rate and clinical pregnancy.Participants/materials, setting, methodsWomen were categorised in the three cohorts- unvaccinated (Group 1), defined as the reference group, women who had first dose of COVID-19 vaccine (Group 2) and patients who had two doses of the vaccine (Group 3). Patients whose vaccination status were not known were excluded. Statistical analysis was performed through STATA software. Outcomes were modelled with multivariable logistic and negative binomial regressions and adjusted for the following confounders: age, BMI, parity and past COVID-19 infection.Main results and the role of chanceData from women was analysed, 22.6 % had completed 2 doses, 9.5 % had one vaccine and 9.7% were unvaccinated. Among these women 24.7% had previous COVID-19 infection prior to their IVF cycle.The median number of oocytes retrieved for the entire cohort collected was 10.0 (inter-quartile range (IQR) 6.0, 14.0). There was no significant difference in the number of oocytes retrieved between women who had 1 vaccination dose, 2 doses compared to unvaccinated women (Incidence rate ratios (IRR) 1.18, 95% Confidence Interval (CI) [0.93,1.50] and 0.94, 95% CI [0.76,1.15] respectively).There was no significance difference in the fertilisation rate between women who had one vaccination dose, 2 doses and unvaccinated women (IRR)1.02, 95% CI [0.83, 1.24] and 1.11 95% CI [0.93, 1.31] or failed fertiisation rates (Odds ratio (OR) 0.74, 95% CI [0.09, 6.09] and 0.71, 95% CI [0.12, 4.18].With regards to clinical outcomes, 51.7% of the cohort had a positive urine pregnancy test. There was no significant difference in clinical pregnancy rate between women who had first vaccination dose and those who had both doses compared to unvaccinated women (OR 3.06, 95% CI [0.37, 3.68] & OR 1.7, 95% CI [ 0.64, 4.52] respectively).Limitations, reasons for cautionThis is a retrospective study and further accumulated data is warranted to validate the findings. Many patients at the time of analysis were still pregnant, hence we await live birth outcomes.Wider implications of the findingsThis is the first study to analyse the impact of COVID-19 vaccination on IVF outcomes. These initial findings are reassuring to patients and fertility clinicians on the safety of vaccination.Trial registration numbernot applicable

P-740 Social disparities in pregnancy awareness among individuals in the general U.S. population

Abstract Study question What are socio-demographic and lifestyle characteristics of pregnant individuals who were aware versus those who were unaware of pregnancy status in the general U.S. population. Summary answer Women unaware of their pregnancy status were more likely to be Non-Hispanic Black, living below the poverty line, and unmarried. What is known already The early weeks of pregnancy are critical for fetal programming of organ systems and consequently long-term offspring health. Individuals who are unaware of pregnancy are at risk of poor nutrition, inadvertent environmental chemical exposures and risky behaviors/lifestyles that contribute to inadequate prenatal care. Lack of pregnancy awareness increases the risk of pregnancy complications and misses opportunities for early intervention. Study design, size, duration We included 842 individuals aged between 20 to 44 years who had a positive urine pregnancy test result at time of the cross-sectional National Health and Examination Survey (NHANES), 2003-2016 cycles. Participants/materials, setting, methods The urine pregnancy tests and reproductive health interviews were conducted concurrently in medical examination center. We defined participants with a positive urine pregnancy test result but who reported not being pregnant during the interview as being unaware of their pregnancy status. Information on demographic, socio-economic, and lifestyle characteristics were collected by questionnaires. We employed student t test and chi-square test to compare the characteristics between individuals who were aware vs. unaware of the pregnancy. Main results and the role of chance Among 842 pregnant individuals, 62 (7.36%) were unaware of their pregnancy status. The mean (SE) ages (years) were similar between individuals who were unaware vs. those aware of their pregnancy status (Unaware: 28.05 (0.96) vs. Aware: 28.48 (0.32)). Compared with aware individuals, a higher proportion of the unaware group were Non-Hispanic Black (Unaware: 36.31% vs. Aware: 13.06%; p &amp;lt; 0.001), living in poverty (Unaware: 30.03% vs. Aware: 18.95%; p = 0.09), and unmarried (Unaware: 68.12% vs. Aware: 30.45%; p &amp;lt; 0.001). No significant differences were found for education (College degree and above: Unaware: 60.73% vs. Aware: 67.73%; p = 0.33) and smoking behavior between the two groups (Current smoker: Unaware: 4.97% vs. Aware: 8.88%; p = 0.38). Limitations, reasons for caution The sample size of this study was relatively small. Findings may not be representative of population characteristics. Wider implications of the findings Our findings point to significant social disparities in pregnancy awareness and have important implications for clinical practice and early identification of high-risk pregnancies. Trial registration number not applicable

An early return to fertility resulting in ectopic pregnancy 10 weeks post vaginal birth: A case report

Background: There exists an unmet need for timely initiation of reliable postpartum contraception among mothers. This could result in unplanned and closely spaced pregnancies that may endanger the lives of the mother and the unborn baby.&#x0D; Case presentation: A 22-year-old para 1+0 presented to the emergency department with gradual onset of lower abdominal pains, per vaginal spotting, and bloating 10 weeks after childbirth. She reported full-time breastfeeding and regular and consistent use of male condoms for contraception. A diagnosis of ectopic pregnancy was established following a positive urine pregnancy test and a transabdominal ultrasound that revealed features of right tubal pregnancy. Exploratory laparotomy and partial salpingectomy were performed. The patient was stable and was discharged on the second postoperative day.&#x0D; Conclusion: Early return of fertility in exclusively breastfeeding mothers is possible; hence, an effective family planning method is needed during the postpartum period to minimize the complications of short interpregnancy intervals.

Contraceptive effectiveness, pharmacokinetics, and safety of Sayana® Press when injected every four months: a multicenter phase 3 trial.

SummaryBackgroundSayana Press® is a 3-monthly contraceptive injection approved by regulatory agencies in more than 40 countries worldwide. Existing effectiveness and pharmacokinetics (PK) data suggest that high contraceptive efficacy may be maintained if the reinjection interval of Sayana Press is extended from 3 to 4 months.MethodsWe conducted a phase 3 trial at three sites in the Dominican Republic, Brazil, and Chile from September 2017 through April 2020. We enrolled 750 women at risk of pregnancy who agreed to use Sayana Press off-label every 4 months (3 treatment cycles) for 12 months. The effectiveness cohort included 710 participants randomized equally to receive injections in the abdomen or thigh. Forty additional participants received injections in the back of the upper arm for comparative PK analyses. The primary outcome was pregnancy, defined by a positive urine pregnancy test confirmed by ultrasound and/or serum human chorionic gonadotropin. Secondary outcomes included PK, safety, and acceptability. Laboratory and trial Sponsor staff were blind to injection site. This study is registered with ClinicalTrials.gov, number NCT03154125.FindingsThere were no pregnancies during follow-up; the Pearl Index during 629.3 woman-years (WY) of follow-up in the primary effectiveness analysis was 0.00 (95% CI 0.00, 0.59). Pharmacokinetic profiles differed by injection site, with higher geometric mean (GM) medroxyprogesterone acetate concentrations for the abdomen than the thigh and arm. At month 8, significantly higher GM concentrations were observed in the abdomen and the thigh as compared to the arm, as well as at month 12 in the abdomen as compared to the arm. Injection site reactions were reported by 10.7% of participants.InterpretationBoth pregnancy and PK results confirm that Sayana Press is a highly effective contraceptive method when administered every 4 months. These findings may inform modification of the dosing schedule, or duration of the grace period for reinjection, or both, to reduce overall drug exposure while maintaining contraceptive efficacy.FundingThis work is made possible by the generous support of the American people through the U.S. Agency for International Development (USAID), provided to FHI 360 through Cooperative Agreement AID-OAA-A-15–00,045, and a grant from the Gates Foundation. The contents are the responsibility of FHI 360 and do not necessarily reflect the views of USAID, the United States Government, or the Gates Foundation, nor does any mention of trade names, commercial products, or organizations imply endorsement by FHI 360, USAID, the United States Government, or the Gates Foundation.