Serum Protein Dynamics in Early Pregnancy Loss Management: Findings from the PreFaiR Trial

Objective: Our objective was to evaluate the feasibility of a new protocol for telemedicine follow-up after medication management of early pregnancy loss. Study Design: The study was designed to assess the feasibility of planned telemedicine follow-up after medication management of early pregnancy loss. We compared these follow-up rates with those after planned in-person follow-up of medication management of early pregnancy loss and planned telemedicine follow-up after medication abortion. We conducted a retrospective cohort study, including patients initiating medication management of early pregnancy loss <13w0d gestation and medication abortion ≤10w0d with a combination of mifepristone and misoprostol between April 1, 2020, and March 28, 2021. As part of a new clinical protocol, patients could opt for telemedicine follow-up one week after treatment and a home urine pregnancy test 4 weeks after treatment. Our primary outcome was completed follow-up as per clinical protocol. We also examined outcomes related to complications across telemedicine and in-person follow-up groups. Results: Of patients reviewed, 181 were eligible for inclusion; 75 had medication management of early pregnancy loss, and 106 had medication abortion. Thirty-six out of 75 patients elected for telemedicine follow-up after early pregnancy loss. Of patients scheduled for telemedicine follow-up, 29/36 (81%, 95% CI: 64-92) with early pregnancy loss and 64/69 (93%, 95% CI: 84-98) undergoing medication abortion completed follow-up as per protocol (p = 0.06). Completed follow-up was also similar among patients undergoing medication management of early pregnancy loss who planned for in-person follow-up (p = 0.135). Complications were rare and did not differ across early pregnancy loss and medication abortion groups. Conclusions: Telemedicine follow-up is a feasible alternative to in-person assessment after medication management of early pregnancy loss.

“Every Person's Just Different”: Women's Experiences with Counseling for Early Pregnancy Loss Management

BackgroundMedical management of early pregnancy loss is an alternative to uterine aspiration, but standard medical treatment with misoprostol commonly results in treatment failure. We compared the efficacy and safety of pretreatment with mifepristone followed by treatment with misoprostol with the efficacy and safety of misoprostol use alone for the management of early pregnancy loss.MethodsWe randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed to receive pretreatment with 200 mg of mifepristone, administered orally, followed by 800 μg of misoprostol, administered vaginally (mifepristone-pretreatment group), or 800 μg of misoprostol alone, administered vaginally (misoprostol-alone group). Participants returned 1 to 4 days after misoprostol use for evaluation, including ultrasound examination, by an investigator who was unaware of the treatment-group assignments. Women in whom the gestational sac was not expelled were offered expectant management, a second dose of misoprostol, or uterine aspiration. We followed all participants for 30 days after randomization. Our primary outcome was gestational sac expulsion with one dose of misoprostol by the first follow-up visit and no additional intervention within 30 days after treatment.ResultsComplete expulsion after one dose of misoprostol occurred in 124 of 148 women (83.8%; 95% confidence interval [CI], 76.8 to 89.3) in the mifepristone-pretreatment group and in 100 of 149 women (67.1%; 95% CI, 59.0 to 74.6) in the misoprostol-alone group (relative risk, 1.25; 95% CI, 1.09 to 1.43). Uterine aspiration was performed less frequently in the mifepristone-pretreatment group than in the misoprostol-alone group (8.8% vs. 23.5%; relative risk, 0.37; 95% CI, 0.21 to 0.68). Bleeding that resulted in blood transfusion occurred in 2.0% of the women in the mifepristone-pretreatment group and in 0.7% of the women in the misoprostol-alone group (P=0.31); pelvic infection was diagnosed in 1.3% of the women in each group.ConclusionsPretreatment with mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone. (Funded by the National Institute of Child Health and Human Development; PreFaiR ClinicalTrials.gov number, NCT02012491.)

We aimed to: (a) describe current use of mifepristone for early pregnancy loss (EPL) management in Utah, (b) identify predictors of knowledge pre- and posteducational video, and (c) explore postvideo impacts on the likelihood to use mifepristone. Mifepristone is subject to the Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategy (REMS) requirements. Between September 2020 and March 2021 we surveyed Utah clinicians from six specialties caring for people experiencing EPL, recruited through professional organizations and hospital listservs. Participants viewed a 3.5-minute educational video on mifepristone for EPL and completed pre- and postvideo questionnaires. We evaluated predictors of high prevideo and improved postvideo knowledge using random forest regression conditional importance measures and partial dependency plots. We described current mifepristone use and video effects on likelihood to use mifepristone. Of 506 participants, most specialize in emergency medicine (172, 34%) and practice in private settings (253, 51%). Two-thirds had heard of mifepristone (328/471, 70%). Of 176/471 (37%) attempting provision of mifepristone, actual provision occurred for 59% (104/176). Baseline knowledge scores were low (mean 4.81/13 [37%] correct). Predictors of high prevideo knowledge include provision or attempted provision of mifepristone, having heard of mifepristone, providing EPL management expectantly or via medication, and specialty type. Mean postvideo knowledge scores improved by 3.27 points (68% improvement, paired t-test; 95% confidence interval 2.82-3.72, p < 0.0001). Postvideo, 66% (242/364) stated they are much more or somewhat more likely to use mifepristone, with compliance with FDA requirements cited as a barrier to utilization. Among Utah providers, baseline mifepristone knowledge and use for EPL management are low. An educational video improved knowledge and likelihood of use, but FDA REMS requirements continue to be a barrier to including mifepristone in medication management of EPL.

BackgroundEstrogen has been usually used in clinic for medical pretreatment of early pregnancy loss. There was little reported the effect of estrogen combined with prostaglandin analogs in the medical management of early pregnancy loss. This retrospective study aimed to evaluate the efficacy of estrogen pretreatment for medical management of early pregnancy loss and explore the confounding factor of intrauterine adhesion (IUA) on the outcome of medical management.MethodsA total of 226 early pregnancy loss patients who received pretreatment with estradiol valerate and/or mifepristone, followed by carboprost methylate suppositories (study groups), or carboprost methylate suppositories alone (control group) in a regional central institution from March 2020 to February 2021 were retrospectively studied. All patients were evaluated by hysteroscopy 6 h after carboprost methylate suppositories use to assess whether the gestational sac was complete expulsion and assess the morphology of uterine cavity.ResultsThe complete expulsion rate was 56.94% in the mifepristone and estradiol valerate-pretreatment group, 20.69% in the estradiol valerate-pretreatment group, 62.5% in the mifepristone-pretreatment group, and 12.5% in the control group. Compared with the control group, pretreatment with estradiol valerate did not increase the complete expulsion rate significantly (P = 0.297), pretreatment with mifepristone increased the complete expulsion rate significantly (P < 0.001). Pretreatment with mifepristone combined with estradiol valerate did not increase the complete expulsion rate significantly comparing with pretreatment with mifepristone (P = 0.222). The data of IUA showed that the complete expulsion rate in patients with IUA was lower than that in those patients without IUA (P < 0.001).ConclusionsPretreatment with estrogen was not a sensible substitute for mifepristone in the medical management of early pregnancy loss. Mifepristone followed by carboprost methylate suppositories was likelihood of the ideal medical scheme in early pregnancy loss. IUA decreased the complete expulsion rate of medical management, it is cautious about medical management for early pregnancy loss with risk of IUA.Trial Registration Number: ChiCTR2100046503. Date of registration (retrospectively registered): May 18, 2021. Trial registration website: http://www.chictr.org.cn/.

A randomised controlled trial of expectant management versus surgical evacuation of early pregnancy loss

Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial

US clinicians’ perspectives on how mifepristone regulations affect access to medication abortion and early pregnancy loss care in primary care

Preeclampsia is a clinical syndrome defined as the new onset of hypertension and proteinuria during the second half of pregnancy.1 It afflicts 3% to 5% of pregnancies and is a leading cause of maternal mortality, especially in developing countries.2,3 Because the only known remedy is delivery of the placenta, in developed countries preeclampsia is an important cause of premature delivery, usually medically indicated for the benefit of the mother. This results in infant morbidity and substantial healthcare expenditure.4 Despite the considerable morbidity and mortality, the cause of preeclampsia has remained enigmatic. Both hypertension and proteinuria implicate the endothelium as the target of the disease. The hypertension of preeclampsia is characterized by peripheral vasoconstriction and decreased arterial compliance.5,6 The proteinuria of preeclampsia is associated with a pathognomonic renal lesion known as glomerular endotheliosis, in which the endothelial cells of the glomerulus swell and endothelial fenestrations are lost.7,8 Podocyturia has been recently associated with preeclampsia during clinical disease9; however, whether this is the cause or effect of proteinuria is unknown. The glomerular filtration rate is decreased compared with normotensive pregnant women; in rare cases, acute renal failure may develop. Preeclampsia is a systemic vascular disorder that may also affect the liver and the brain in the mothers. When the liver is involved, women may present with abdominal pain, nausea, vomiting, and elevated liver enzymes. Pathological examination of the liver reveals periportal and sinusoidal fibrin deposition and, in more extreme cases, hemorrhage and necrosis.10 The severe preeclampsia variant HELLP syndrome (hemolysis, elevated liver enzymes, low platelets) occurs in ≈20% of women with severe preeclampsia,11 and is named not only for the liver involvement, but also for the disorder of the coagulation system that develops.12 Approximately 20% of …

Background: Management of early pregnancy loss is very crucial for the safety of women.&#x0D; Objective: The purpose of the present study was to see the safety and efficacy of misoprostol for the management of early pregnancy loss.&#x0D; Methodology: This non-randomized clinical trial was conducted in the Department of Obstetrics and Gynaecology in Shaheed Ziaur Rahman Medical College Hospital, Bogra, Bangladesh from January 2007 to December 2007 for a period of 12 months. Women with early pregnancy loss who were fulfilling the selection criteria were selected as the study population during the study period. On admission all women were received a vaginal administration of 800 μg misoprostol by digital insertion into the posterior fornix through a speculum (4 tablets of 200 μg misoprostol). The interval between administration of misoprostol and expulsion of product of conception was recorded. After 7 days (8th day) they were instructed to come to the hospital to see the completeness of expulsion of product of conception by ultrasonography. If sonography shows incomplete expulsion then surgical evacuation was done. Every woman were advised to come for follow-up on 15th day. Results: A total of 200 women with first-trimester pregnancy loss were non-randomly assigned to give treatment with misoprostol. The mean with the SD of the study population was 24.95±4.17 years. In most cases expulsion occurred within 24 hours of application of misoprostol, 142(71.0%) cases completed expulsion within 48 hours, 168(84.0%) cases within 7 days, 170(85.0%) cases out of 200 cases completed expulsion occurred. Complete evacuation after the first dose was in 142(71.0%) cases and remained incomplete was 58(29.0%) cases. After administration of the second dose (85.0%) complete evacuation occurred and 30(15.0%) cases remained complete that needed surgical evacuation. Analysis was reveled statistically significant (P&lt;0.05). Vaginal misoprostol treatment appeared to be well tolerated. Only few percent shows mild side effects. About 190(95.0%) cases required no blood transfusion. Conclusion: In conclusion the efficacy of misoprostol for the management of early pregnancy loss gives a good results with minimum adverse events.&#x0D; Journal of National Institute of Neurosciences Bangladesh, July 2022;8(2):152-156

Hysteroscopic Resection of Early Pregnancy Loss

Introduction: Pregnancy loss is a phenomenon mostly researched from the perspectives of expectant mothers. Nevertheless, the loss is equally a painful experience for the male partners as well. Therefore, excluding them during early pregnancy loss management has created a research gap that needs to be addressed.Methodology: This review analysed international guidelines on early pregnancy loss management to understand the consideration of male partner management during the early pregnancy loss process. The research team reviewed twelve (12) international guidelines written in English from official websites until August 2020. Through this review, the research team answered the study’s research question and aim.Results: There are limited guidelines and no clear protocols in involving, care, counselling, or support of male partners during or after the process or even psychological care for males victimised by early pregnancy loss. In general, specific guidelines considering male partners with specifications on each time loss are necessary to provide sufficient emotional and psychological support. Molar and ectopic pregnancies’ impact on men must be investigated further. Insufficient recognition and support provided to the grieving couples post an early pregnancy loss for men. Society and healthcare providers and practitioners must pay attention to the lack of support given post-loss, especially male partners.Conclusion and Recommendations: Thorough steps need to be taken to acknowledge the gravity of including male partners in early pregnancy loss management and validating that they are also emotionally affected like their women partners. Specific guidelines, which include male partners, are recommended for the management of early pregnancy loss.

Menopausal hormone therapy: summary of a scientific workshop.

To explore the relationship between race and depression symptoms among participants in an early pregnancy loss clinical trial. We performed a planned secondary analysis of a randomized trial by comparing treatments for medical management of early pregnancy loss. We hypothesized that Black participants would have higher odds of risk for major depression (measured with the CES-D [Center for Epidemiological Studies-Depression] scale) 30 days after early pregnancy loss treatment when compared with non-Black participants. We analyzed the data as a cohort, with the primary exposure being race and secondary exposure being high adverse childhood experience scores (measured with the Adverse Childhood Experience scale). Our primary outcome was risk for major depression (score of 21 or higher on the CES-D scale) 30 days after early pregnancy loss treatment. Three hundred participants diagnosed with a nonviable intrauterine pregnancy from 5 to 12 weeks of gestation were randomized as part of the original trial from May 2014 to April 2017. Of 275 respondents included in this analysis, 120 [44%] self-identified as Black and 155 [56%] self-identified as non-Black. After early pregnancy loss treatment, 65 [24%] participants were at risk for major depression. Black participants had an increased risk for major depression (57%) after early pregnancy loss treatment compared with non-Black participants (43%; odds ratio [OR] 2.02; 95% CI 1.15-3.55). After adjustment for risk for baseline depression, adverse childhood experience score, and parity, the odds of risk for major depression 30 days after pregnancy loss treatment remained higher for Black participants when compared with non-Black participants (OR 2.02; 95% CI 1.15-3.55; adjusted OR 2.48; 95% CI 1.28-4.81). Overall, approximately one quarter of women who experience an early pregnancy loss are at an increased risk for major depression 30 days after treatment. This risk is about twice as high for Black women compared with non-Black women. There is a need for appropriate mental health resources for women undergoing early pregnancy loss care. ClinicalTrials.gov, NCT02012491.

Hysteroscopic resection for management of early pregnancy loss: a case report and literature review