Fetal Adverse Events Research Articles

Maternal Comorbidities and Complications of Delivery in Pregnant Women With Congenital Heart Disease

BackgroundPregnant women with congenital heart defects (CHDs) may be at increased risk for adverse events during delivery. ObjectivesThis study sought to compare comorbidities and adverse cardiovascular, obstetric, and fetal events during delivery between pregnant women with and without CHDs in the United States. MethodsComorbidities and adverse delivery events in women with and without CHDs were compared in 22,881,691 deliveries identified in the 2008 to 2013 National Inpatient Sample using multivariable logistic regression. Among those with CHDs, associations by CHD severity and presence of pulmonary hypertension (PH) were examined. ResultsThere were 17,729 deliveries to women with CHDs (77.5 of 100,000 deliveries). These women had longer lengths of stay and higher total charges than women without CHDs. They had greater odds of comorbidities, including PH (adjusted odds ratio [aOR]: 193.8; 95% confidence interval [CI]: 157.7 to 238.0), congestive heart failure (aOR: 49.1; 95% CI: 37.4 to 64.3), and coronary artery disease (aOR: 31.7; 95% CI: 21.4 to 47.0). Greater odds of adverse events were observed, including heart failure (aOR: 22.6; 95% CI: 20.5 to 37.3), arrhythmias (aOR: 12.4; 95% CI: 11.0 to 14.0), thromboembolic events (aOR: 2.4; 95% CI: 2.0 to 2.9), pre-eclampsia (aOR: 1.5; 95% CI: 1.3 to 1.7), and placenta previa (aOR: 1.5; 95% CI: 1.2 to 1.8). Cesarean section, induction, and operative vaginal delivery were more common, whereas fetal distress was less common. Among adverse events in women with CHDs, PH was associated with heart failure, hypertension in pregnancy, pre-eclampsia, and pre-term delivery; there were no differences in most adverse events by CHD severity. ConclusionsPregnant women with CHDs were more likely to have comorbidities and experience adverse events during delivery. These women require additional monitoring and care.

Does nifedipine improve outcomes of embryo transfer?: Interim analysis of a randomized, double blinded, placebo-controlled trial.

Implantation failure is the main factor affecting the success rate of in vitro fertilization (IVF) procedures. Studies have reported that uterine contractions (UC) at the time of embryo transfer (ET) were inversely related to implantation and pregnancy rate, hence reducing the success of IVF treatments. Various pharmacological agents, with the exception of calcium channel blockers, have been investigated to improve ET outcomes by reducing UC. Thus, a double-blinded randomized, placebo-controlled trial was conducted to determine whether nifedipine, a calcium channel blocker with potent smooth muscle relaxing activity and an excellent safety profile, can improve the outcome of patients undergoing ET treatments. Ninety-three infertile women were recruited into 1 of 2 groups: placebo (n = 47) or nifedipine 20 mg (n = 46). Study participants were admitted 30 minutes prior to ET and given either tablet after their baseline vital signs were recorded. They then underwent ET and were observed for adverse events for another 30 minutes post-ET. Follow up of the participants' outcomes was conducted via electronic medical records. The primary outcomes are implantation and clinical pregnancy rates. Secondary outcomes include any maternal or fetal adverse events, miscarriage, pregnancy, live births, and neonatal outcomes. Resulting data were then analyzed using t test, Pearson chi-square test, and Fisher exact test to compare outcomes between the 2 groups. No statistical differences in the implantation rate (42.6% vs 39.1%, P = .737, rate ratio 0.868, 95% confidence interval [CI]: 0.379-1.986) and the clinical pregnancy rate (23.4% vs 26.1%, P = .764, rate ratio 1.155, 95% CI: 0.450-2.966) were detected between the placebo and the treatment groups. In addition, no statistical significance between the placebo and the treatment groups for any secondary outcomes were detected. This double blinded, randomized, and placebo-controlled trial demonstrated that the single use of 20 mg nifedipine given 30 minutes before embryo transfer did not improve the implantation rate or the clinical pregnancy rate of the infertility treatment. Further studies are required to demonstrate the clinical benefits and risks of nifedipine usage in embryo transfer.

Antenatal Antiarrhythmic Treatment for Fetal Tachyarrhythmias: A Prospective Multicentre Trial

Background: Standardized treatment of fetal supraventricular tachycardia (SVT) and atrial flutter (AFL) has not been established. The aim of this study was to evaluate the safety and efficacy of protocol-defined transplacental treatment for fetal SVT and AFL. Methods: In this multicentre single-arm trial (UMIN Clinical Trials Registry number 000004270), protocol-defined transplacental treatment using digoxin, sotalol, and flecainide was performed for singletons from 22 to <37 weeks of gestation with sustained fetal SVT or AFL ≥180 beats per minute. The primary endpoint was resolution of fetal tachyarrhythmia. Secondary endpoints were fetal death, preterm birth, neonatal arrhythmia, and neonatal survival. Maternal, fetal, and neonatal adverse events (AEs) were evaluated. Findings: A total of 50 participants were enrolled and treated at 15 institutions in Japan from October 2010 to January 2017. They had short VA SVT (n=17), long VA SVT (n=4), and AFL (n=29). One participant with AFL was excluded due to withdrawal of consent. Fetal tachyarrhythmia resolved in 89·8% (44 of 49) of cases overall and 75·0% (3 of 4) of cases with fetal hydrops. Preterm births occurred in 20·4% (10 of 49) of participants. Maternal AEs were observed in 78·0% (39 of 50) of pregnant women. Severe AEs occurred in one mother and four fetuses, resulting in discontinuation of protocol treatment in four participants. Two fetal deaths occurred, mainly due to heart failure. No neonatal deaths occurred. Neonatal tachyarrhythmia was observed in 31·9% (15 of 47) of participants within 2 weeks after birth, except for one neonate with SVT. Interpretation: Protocol-defined transplacental treatment for fetal SVT and AFL was effective and tolerable in 90% of participants. However, it should be kept in mind that severe AEs may take place in fetuses and that recurrence of tachyarrhythmias may happen within 2 weeks after birth. Clinical Trials Number: UMIN Clinical Trials Registry number 000004270 Funding Statement: This work was supported by a grant from the Ministry of Health, Labor and Welfare of Japan (Health and Labour Science Research Grants for Clinical Research for New Medicine) (H19-009, H23-004), and in part by a grant from the Takeda Science Foundation (J042) and Tsuchiya Foundation (J151). Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: The Institutional Review Board of the National Cerebral and Cardiovascular Center of Japan.

Preconceptions and awareness of good glycemic control, pregnancy contraindications, and maternal and fetal adverseevents in Sudan.

Awareness around glycemic control was very low among women in Sudan who were pregnant and had diabetes.

Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol

BackgroundMaternal obesity is a risk factor for adverse maternal, fetal, and neonatal events. Numerous clinical trials are currently exploring the effectiveness of antenatal and peripartum interventions in improving pregnancy outcomes that can in future inform clinical practice. However, the heterogeneity in outcome reporting limits our ability to compare outcomes across studies, and there is a lack of stakeholder representation in outcome choice. A pragmatic solution to this problem is the development of a core outcome set (COS) that defines the minimum criteria for outcome reporting in clinical trials undertaken in this population, arrived at by the involvement of relevant stakeholders.MethodsThe development of a COS for studies on obesity in pregnant patients (COSSOPP) will comprise five steps. First, a systematic review of published literature will identify the long list of outcomes, their definitions and measurements if applicable, and outcome reporting quality. This will be followed by a meta-synthesis of qualitative studies with patients, and qualitative interviews in Toronto with patients, clinicians, researchers, hospital administrators, and policy-makers, to identify novel outcomes that were not obtained through systematic review. Third, the long list of outcomes will be narrowed down through online Delphi surveys involving an international group of patients and relevant stakeholders. This will be followed by a face-to-face consensus meeting with representatives of all stakeholder groups to arrive at a consensus on the final COS. Finally, in order to determine how the identified core outcomes should be measured, we will conduct another literature review and Delphi process.DiscussionCOSSOPP will engage patients, clinicians, researchers, and other relevant stakeholders in determining the core set of outcomes that should be reported and measured in order to harmonize outcome reporting in studies evaluating the effectiveness of antepartum and peripartum interventions in obese pregnant women. This protocol provides a detailed overview of the steps involved in the development of a COS, to guide researchers in developing COS within their areas of specialization.COMET Core Outcome Set Registrationhttp://www.comet-initiative.org/studies/details/939.

Outcomes of Pregnancy in Mothers With Cirrhosis: A National Population-Based Cohort Study of 1.3 Million Pregnancies.

There are limited data on pregnancy outcomes in women with cirrhosis. To address this gap, we examined the records of singleton births from Sweden’s National Patient Register (NPR), Cause of Death Register (CDR), and Medical Birth Register (MBR) between 1997 and 2011 to assess exposure and pregnancy‐related and liver‐related outcomes of pregnant women with cirrhosis. Exposure status was defined as having an International Classification of Diseases (ICD) code for cirrhosis obtained prior to or during pregnancy. Poisson regression with cluster‐robust standard errors was used to estimate relative risks (RRs) adjusted for maternal age, smoking, and body mass index (BMI). We identified 103 pregnancies in women with cirrhosis and compared these to 1,361,566 pregnancies in women without cirrhosis. Pregnancies in women with cirrhosis were at increased risk of caesarean delivery (36% versus 16%, respectively; adjusted RR [aRR], 2.00; 95% confidence interval [CI], 1.47‐2.73), low birth weight (15% versus 3%; aRR, 3.87; 95% CI, 2.11‐7.06), and preterm delivery (19% versus 5%; aRR, 3.51; 95% CI, 2.16‐5.72). Rates of maternal mortality during pregnancy (no cases), gestational diabetes, preeclampsia, small for gestational age, congenital malformations, and stillbirth were not increased when compared to the pregnant women without cirrhosis. There were 12 hospitalizations during pregnancy due to liver‐related events, including one case with bleeding esophageal varices. Conclusion: Women with cirrhosis are at increased risk for adverse pregnancy outcomes. However, severe maternal and fetal adverse events were rare in our study, and most pregnancies in women with cirrhosis ended without complications.

448. Ischemic heart disease and pregnancy – Results from the ESC Registry of Pregnancy and Cardiac Disease (ROPAC)

Introduction Pregnancy in women with a history of ischemic heart disease (IHD) is increasingly common due to increasing maternal age and higher rates of obesity, smoking, diabetes and hypertension. Objective To describe the maternal and fetal pregnancy outcomes in women with pre-existing and pregnancy-onset IHD. Methods Within the international, prospective ESC Registry of Pregnancy And Cardiac disease (ROPAC), we describe maternal and fetal outcomes of pregnancy in patients with IHD. Results A total of 117 patients with IHD were included with a mean age of 34.9 years. 88% had pre-existing IHD and 11% experienced a first ischemic event during pregnancy. Pre-pregnancy smoking occurred in 17%, hypertension in 27%, diabetes and heart failure both in 15%, and 13% of patients had a left ventricular ejection fraction of below 40%. Almost half of the patients were using cardiac medication including anticoagulation (49%). There were no cases of maternal mortality, ACS and heart failure during pregnancy occurred in 21% and 7% respectively. Ventricular tachyarrhythmias were seen in 2%. Median pregnancy duration was 38.2 weeks. Mode of delivery was caesarean section (CS) in 65 patients (56%), of which 12 (10%) underwent emergency CS. Preterm birth was seen in 22% and low Apgar scores in 9%. Three babies died within 6 months after delivery (3%), all of whom were born prematurely. Six percent of patients suffered from post-partum hemorrhage. No clinical determinants for ACS during pregnancy or fetal adverse events were found. Discussion Women with IHD tolerate pregnancy relatively well, however, while there were no maternal deaths in our study, 21% of patients suffered from ACS during pregnancy. Fetal adverse outcome was also not uncommon.

381. Pregnancy outcome in women with uncorrected single ventricle: A single center experience from South India

Introduction Occurrence of single ventricle accounts for 0.5–1.5% of the congenital heart disease in whom survival to adulthood, without surgical intervention, is difficult. Hemodynamic changes during pregnancy poses a challenge, resulting in increased risk of maternal and fetal complications such as heart failure, arrhythmias, miscarriage, low birth weight, complications secondary to premature delivery etc. We report the experience of management of women with single ventricle and compare them with concurrent controls. Material & Methods We collected demographic, medical and obstetric details of women with diagnosis of uncorrected single ventricle admitted to a regional tertiary care center in south India during the time period from 2011 to 2017. We also collected the details of 4:1 age matched controls without diagnosis of single ventricle. Outcomes assessed were mode of delivery, maternal mortality, neonatal death and low birth weight. Comparisons were done using Mann–Whitney test or Chi-square test as appropriate. Results We compared 12 pregnancies in 5 women with uncorrected single ventricle to controls. Two women were on Sildenafil for severe pulmonary hypertension (PAH). Sudden death occurred in a primigravida lady at 26 weeks with Complete AV canal defect with severe PAH following delivery. One patient developed heart failure in third trimester. Cesarean Section (12.5% vs 17.5%, p = 0.729) were similar. Pre-term delivery (30% vs 5%, p = 0.014), low birth weight (50% vs 10%, p = 0.002) and perinatal death (25% vs 2.5%, p = 0.002) were higher compared to the controls. Conclusion Women with single ventricle are at higher risk of maternal or fetal adverse events during pregnancy and peri-partum period. Care under multi-disciplinary team can help optimize the outcome of pregnancy if the women wish to continue pregnancy after thorough counselling.

Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study

IntroductionHepatitis B virus (HBV) infection acquired during pregnancy can pose a risk to the infant at birth that can lead to significant and lifelong morbidity. Hepatitis B vaccine (HepB) is recommended for anyone at increased risk for contracting HBV infection, including pregnant women. Limited data are available on the safety of HepB administration during pregnancy. ObjectivesTo assess the frequency of maternal HepB receipt among pregnant women and evaluate the potential association between maternal vaccination and pre-specified maternal and infant safety outcomes. MethodsWe examined a retrospective cohort of pregnancies in the Vaccine Safety Datalink (VSD) resulting in live birth outcomes from 2004 through 2015. Eligible pregnancies in women aged 12–55 years who were continuously enrolled from 6 months pre-pregnancy to 6 weeks postpartum in VSD integrated health systems were included. We compared pregnancies with HepB exposure to those with other vaccine exposures, and to those with no vaccine exposures. High-risk conditions for contracting HBV infection were identified up to one-year prior to or during the pregnancy using ICD-9 codes. Maternal and fetal adverse events were also evaluated according to maternal HepB exposure status. ResultsAmong over 650,000 pregnancies in the study period, HepB was administered at a rate of 2.1 per 1000 pregnancies (n = 1399), commonly within the first 5 weeks of pregnancy. Less than 3% of the HepB-exposed group had a high-risk ICD-9 code indicating need for HepB; this was similar to the rate among HepB unvaccinated groups. There were no significant associations between HepB exposure during pregnancy and gestational hypertension, gestational diabetes, pre-eclampsia/eclampsia, cesarean delivery, pre-term delivery, low birthweight or small for gestational age infants. ConclusionsMost women who received maternal HepB did not have high-risk indications for vaccination. No increased risk for the adverse events that were examined were observed among women who received maternal HepB or their offspring.

Safety of Laparoscopic Surgery for Benign Diseases during Pregnancy: A Nationwide Retrospective Cohort Study

Study ObjectiveTo compare fetal, maternal, and operative outcomes of laparoscopic surgery versus laparotomy for major benign diseases including appendicitis, cholecystitis, adnexal masses, and uterine myoma during pregnancy. DesignRetrospective cohort study (Canadian Task Force classification II-2). SettingThe Diagnosis Procedure Combination database, a national inpatient database for acute care inpatients in Japan. PatientsEligible patients (n = 6018) underwent abdominal surgery (4047 laparotomy and 1971 laparoscopy patients) from July 2010 through March 2016. InterventionsThe 2 groups were compared using propensity score matching analysis. Measurements and Main ResultsThe primary outcome was fetal adverse events, including abortion or stillbirth within 7 days after surgery and premature delivery during hospitalization. Secondary outcomes were operative time, blood transfusion, and length of hospital stay after surgery. Propensity score matching created 740 pairs. Significant difference was observed in the primary outcome between propensity score–matched patients in the laparotomy versus laparoscopy group (1.8% vs .41%, respectively; risk difference, −1.4%; 95% confidence interval, −2.4 to −.30; p = .01). Compared with the laparotomy group, the laparoscopy group had a significantly lower incidence of blood transfusion (2.3% vs .41%, p = .002), shorter operative time (115 vs 95 minutes, p <.001), and shorter hospital stay (9.2 vs 5.9 days, p <.001). ConclusionOur current study using propensity score matching suggests the advantages of laparoscopic surgery for benign diseases compared with laparotomy because laparoscopic surgery had advantages in short-term fetal adverse events, incidence of blood transfusion, operative time, and hospital stay.

Safety trial of tadalafil administered for the treatment of preeclampsia

Purpose: The aim of this study is to evaluate the safety of clinical usage of tadalafil in women with preeclampsia.Materials and methods: Maternal, fetal, and neonatal adverse events were closely examined in eight preeclampsia patients receiving tadalafil treatment.Results: There were no maternal adverse events associated with 10 mg/day of tadalafil. Even at 20 mg/day, only grade 1 headaches in two cases and grade 1 palpitation in one case were observed, which resolved spontaneously within 3 days. At a dose of 40 mg/day, there was only one case of grade 1 headache. All these adverse events were grade 1 and spontaneously resolved within 3 days. There were no fetal adverse events. All observed neonatal adverse events were thought to be caused by prematurity and not related to tadalafil.Conclusion: This study shows that tadalafil treatment for preeclampsia is deemed sufficiently tolerable. Although there was a dose-dependent increase in maternal adverse events, all the adverse events were mild and deemed to be safe for the mother and fetus at all dosages.

Évaluation du bénéfice de l’utilisation d’hydroxychloroquine pour l’obtention d’une grossesse à terme non compliquée en cas de syndrome des antiphospholipides primaire : étude de phase II multicentrique randomisée en double insu versus placebo, HYDROSAPL

Antiphospholipid syndrome is defined by the presence of thrombosis and/or obstetrical adverse events (≥3 recurrent early miscarriage or fetal death or a prematurity<34 weeks of gestation) associated with persistent antiphospholipid antibodies. The pregnancy outcome has been improved by the conventional treatment (aspirin 100mg/day with low molecular weight heparin [LMWH] from 30 to 75% of uncomplicated pregnancies. In PROMISSE study, 19% of pregnancies had at least one obstetrical adverse event despite treatment (maternal, fetal or neonatal complications) in relation with APS. In the European registry of babies born from APS mothers, maternal and foetal adverse events were observed in 13% of cases, with prematurity in 14% despite treatment. The presence of lupus erythematosus, a history of thrombosis, presence of lupus anticoagulant and APL triple positivity are considered as factors associated with unfavorable obstetrical outcome. Hydroxychloroquine (HCQ) has anti-inflammatory and anti-thrombotic properties. Studies in vitro have shown that HCQ is able to restore the placental expression of Annexin V, which has an anticoagulant effect and to prevent the placental injury induced by APL. HCQ used for lupus erythematosus decrease the thrombotic risk and its value for thrombotic APS has been raised in an open labelled French study. In European retrospective study, the addition of HCQ to conventional treatment improved refractory obstetrical APS. Its use during the pregnancy of patients with lupus erythematosus, the evidence of good safety during the pregnancy and follow-up of children born to mothers exposed to HCQ demonstrate an overall good safety profile for mothers and the fetus. This clinical trial is designed to assess the interest of the addition of hydroxychloroquine to conventional treatment in APS during the pregnancy.

Valvular Heart Disease and Pregnancy.

With improving reproductive assistive technologies, advancing maternal age, and improved survival of patients with congenital heart disease, valvular heart disease has become an important cause of morbidity and mortality in pregnant women. In general, stenotic lesions, even those in the moderate range, are poorly tolerated in the face of hemodynamic changes of pregnancy. Regurgitant lesions, however, fare better due to the physiologic afterload reduction that occurs. Intervention on regurgitant valve preconception follows the same principles as a non-pregnant population. Prosthetic valves in pregnancy are increasingly commonplace, presenting new management challenges including valve deterioration and valve thrombosis. In particular, anticoagulation during pregnancy is challenging. Pregnancy is a hypercoagulable state and the risks of maternal bleeding and fetal anticoagulant risks need to be balanced. Maternal mortality and complications are lowest with warfarin use throughout pregnancy; however, fetal outcomes are best with low molecular weight heparin use. ACC/AHA guidelines recommend warfarin use, even in the first trimester, if doses are less than 5mg/day; however, adverse fetal events are not zero at this dose. In addition, it is unclear if better monitoring of low molecular weight heparin with peak and trough anti-Xa levels would lower maternal risks as this has been inconsistently monitored in reported studies. Fortunately, with the emergence of newer data, our understanding of anticoagulant strategies in pregnancy is improving over time which should translate to better pregnancy outcomes in this higher risk population.

Antenatal management of twin anemia-polycythemia sequence

Twin-twin transfusion syndrome (TTTS) and recently discovered twin anemia-polycythemia sequence (TAPS) are well-known severe complications of monochorionic pregnancies which are associated with placental anastomoses. TAPS may occur spontaneously with a prevalence of 3% to 5% in monochorionic pregnancies. It also can occur iatrogenically after laser treatment of TTTS in 2% to 13% of monochorionic pregnancies. Optimal perinatal management for TAPS has not been established yet. It has been reported that early well-timed diagnosis of the disease is very important for reducing fetal adverse events Because of the rarity, the literature is limited to the description of small series or case reports of twins affected by TAPS. Here, we describe diagnosis and management of TAPS case that was diagnosed after laser treatment of TTTS and review the literature about clinical characteristics including clinical features, prenatal characteristics, diagnosis, treatments and short-term outcomes of the TAPS.

Long-term outcome and prognostic factors in pregnant women with pulmonary arterial hypertension associated with congenital heart disease

Objective: To investigate the perinatal outcome, risk factors and long-term outcome of pregnancy complicated with pulmonary arterial hypertension(PAH) and congenital heart diseases (CHD). Methods: Clinical data of 110 pregnant women who were diagnosed as PAH-CHD were retrospectively analyzed in the Department of Obstetrics and Gynecology and Surgical Intensive Care Unit at Beijing Anzhen Hospital from 2004 to 2013. The survival and treatment status were followed up. Results: 110 subjects consisted of 11 mild PAH, 33 moderate and 66 severe ones. The incidences of deterioration in New York Heart Association (NYHA) classes (≥2) during pregnancy, respiratory failure, pulmonary hypertension crisis and arrhythmia were 25.5% (28/110), 7.3% (8/110), 10.0% (11/110), 10.0% (11/110) respectively. Among them, the difference of deterioration in NYHA classes (≥2) during pregnancy among the three groups was statistically significant. A total of 8 (7.3%) maternal deaths occurred during hospitalization, all of whom were severe PAH cases. Multivariate analysis showed that pulmonary artery systolic pressure was a risk factor of perioperative death (OR=1.042, P=0.005). There were 55 cases (50.0%) of term delivery, and 35 cases (31.8%) of iatrogenic abortion. The proportion of term delivery in the severe PAH group was significantly lower. The proportion of iatrogenic abortion and small for gestational age infant (SGA) were higher in severe group. The incidence of neonatal malformations was 8.0% (6/75). The follow-up rate was 61.8% (63/102). Sudden death was reported in a parturient a few days after discharge. The remaining 62 patients survived during follow-up, while 53 patients (85.5%) were functional class (FC) Ⅰ-Ⅱ, 9 (14.5%) were FC Ⅲ-Ⅳ at follow-up. The cardiac function deterioration during pregnancy was not significantly correlated with long-term deterioration (P=0.767). Conclusions: Perinatal mortality and the incidence of maternal and fetal adverse events were high in pregnancy with PAH-CHD. Pulmonary artery systolic pressure is a major risk factor for perioperative mortality in pregnant women. PAH-CHD woman had good overall outcome after puerperium.

Antenatal antiarrhythmic treatment for fetal tachyarrhythmias: a study protocol for a prospective multicentre trial

IntroductionSeveral retrospective or single-centre studies demonstrated the efficacy of transplacental treatment of fetal tachyarrhythmias. Our retrospective nationwide survey showed that the fetal therapy will be successful at an overall rate...

Intracervical foleys catheter: Can it serve as an alternative to standard pharmacological method of cervical ripening?

Background: Ripening of cervix is a prerequisite for successful labour induction. Use of prostaglandins for this purpose incurs a high risk of uterine hyperstimulation and a relatively higher cost of treatment. intracervical Foleys catheter insertion is a mechanical method stated in literature. The present study was to compare the efficacy and safety and cost of intracervical Foleys catheter balloon insertion with intracervical dinoprostone application for preinduction cervical ripening in patients requiring labour induction at term.Methods: This was a randomized, parallel group, active controlled study conducted in the obstetrics department of a tertiary care centre over a duration of one year. Group A received Dinoprostone cervical gel 0.5mg instilled in the cervical canal. Maximum of three doses (1.5mg dinoprostone) could be administered 6 hours apart. Patients randomized to group B were subjected to Foleys catheter insertion. Foleys catheter number 16 was used and balloon was inflated with 60ml of water. Primary efficacy parameter was change in Bishops score as compared to baseline and safety was monitored by comparing the total number of adverse events in the two groups.Results: Total of 89 patients were enrolled into the study during one year period out of which 45 received dinoprostone gel and 44 received Foleys catheter insertion respectively. Change in Bishops score, mode of delivery and total number of maternal and foetal adverse events did not differ significantly between the two groups.Conclusions: Efficacy and safety of Foleys catheter as a cervical ripening agent prior to induction of labour is comparable to dinoprostone gel. Since use of Foleys catheter is advantageous in terms of lack of specific storage conditions and cost of treatment, it could be considered a cost effective alternative for preinduction cervical ripening.

A trial of oral nifedipine and oral labetalol in preeclampsia hypertensive emergency treatment

This observational retrospective cohort study was conducted to compare oral nifedipine and labetalol for emergency treatment of hypertension in preeclamptic patients. Time (minutes) and necessary doses were outlined to achieve blood pressure lower than 150/95 mmHg. In 14 patients with preeclampsia, 55 hypertensive emergencies were identified (BP >150/95). Of these emergencies, 43 were treated with oral nifedipine 10 mg (10 patients) and 12 with oral labetalol 100 mg (4 patients). To achieve a target blood pressure under 150/95, these doses were repeated as necessary every 20 min, up to a maximum of 4 doses. Oral nifedipine reduced BP more rapidly (31.30 vs. 53.50 min, p = .03). No maternal or foetal adverse events were observed and no major differences were found according to the type of delivery. Oral nifedipine is faster than and at least as safe as labetalol in pre-eclampsia hypertensive emergency treatment.

Frequency of Peripartum Gestational Hypertension and Associated Adverse Outcomes [8L

INTRODUCTION: Criteria for gestational hypertension (GH) include only 2 systolic blood pressures (BP) equal or greater than 140 or diastolic BP equal or greater than 90 at least 4 hours apart after 20 weeks gestation. We sought to determine the frequency of previously-normotensive patients meeting criteria for GH when presenting for delivery, and its association with adverse maternal/fetal outcomes. METHODS: We performed a retrospective cohort study of consecutive term deliveries without a diagnosis of hypertensive disorder of pregnancy (HDP) prior to admission. Characteristics of BP elevations, evaluations for and diagnosis of HDP; and associations with adverse composite maternal (seizure, pulmonary edema, unplanned ICU admission, emergent treatment of HTN, stroke, death) or fetal adverse events (5 minute Apgar more than 7, death or unplanned NICU admission) were determined. RESULTS: Of 185 patients, 140 (76%) had at least 1 BP elevation and 55 (30%) met formal criteria for HDP. Most elevated BPs occurred from admission to 1 hour postpartum (73%). Of those meeting GH criteria, only 18 (10%) underwent evaluation and 16 (9%) were formally diagnosed with HDP. A higher rate of fetal composite outcomes (7% vs 1%) was found in patients meeting criteria for HDP. CONCLUSION: BP elevations during admission for delivery were common, and though 30% met the strict definition for GH, only 9% were formally diagnosed reflecting low clinical suspicion. BP elevations through 1 hour postpartum appear to be most often a normal physiologic response to stress rather than a manifestation of HDP, yet GH is associated with risk for poor fetal outcomes.

Comparison of Analgesic Efficacy of Paracetamol and Tramadol for Pain Relief in Active Labor [26O

INTRODUCTION: Labor pain has been described as the most severe pain experienced by women in their lives. To evaluate the efficacy and adverse effects of an intravenous infusion of 1000 mg of paracetamol as compared with an intravenous injection of 50mg of tramadol for intrapartum analgesia. METHODS: In a randomized prospective study,200 women in active labor were allocated to received either paracetamol (n=100) or tramadol (n=100). The primary outcome was the efficacy of the drug to supply adequate analgesia as measured by a change in the visual analog scale (VAS) at various times after drug administration. The secondary outcomes included the need for additional rescue analgesia and the presence of adverse maternal or fetal events. RESULTS: As recorded by the VAS score, there was significant pain reduction at 30 minutes, and at 1 and 2 hours in both groups (P &lt; 0.01). On comparison between group I and II, significantly higher rate of nausea and vomiting in tramadol group (14% vs 8%; P &lt; 0.03) patients. Similarly, drowsiness (0% vs 11%; P &lt; 0.01), dry mouth (0% vs 8%; P &lt; 0.04) and dizziness (0% vs 9%; P &lt; 0.02) was also significant in group II. CONCLUSION: Due to difficulty in administering epidural analgesia to all parturients, administration of paracetamol and tramadol infusion for analgesia is simple and less invasive alternative. In the present study both paracetamol and tramadol were equally effective for labor analgesia but paracetamol has emerged as safe alternative as compared to tramadol due to low incidence of side effects.