SPONTANEOUS MISCARRIAGE AMONG 325 VIABLE PREGNANCIES COMPLICATED BY VAGINAL BLEEDING IN THE FIRST TWENTY WEEKS OF GESTATION

The objectives: To confirm or refute that when the fetal cardiac activity is demonstrated on scan at less than 7 weeks gestation, the risk of miscarriage is not significantly different from the natural-background risk .To ascertain the outcome of threatened miscarriage The setting: The early pregnancy assessment unit at Sharoe Green Hospital, Preston, England, U. K. Design:The study was prospective and observational. The subject:325 pregnant women who presented with viable pregnancies and vaginal bleeding in the first 20 weeks of pregnancy. The intervention:Transabdominal or transvaginal ultrasonography. Statistics:The statistical package, SPSS 9.0 for windows, was used and Pearson’s Chi-square test was selected to compare the groups. P ≥ 0.05. Results:Higher parity and recurrent miscarriages were associated with higher rate of miscarriage. Women presenting with viable pregnancies and moderate to heavy vaginal bleeding had a significantly higher rate of miscarriage (24.1%) compared with (9.0%) in women presenting with mild bleeding (Pearson Chi-square test = 17.516, df = 2, Asymp.sig. (2-Sided) = 0.000). In 37.5% of the women, there were significant differences in the gestational age as calculated by the scan from that calculated by the first day of the Last-Menstrual Period (LMP). The rate of miscarriage (17.5%) amongst women with gestational age of less than 7 weeks was significantly higher than (9.2%) amongst women with gestational age of more than 7 weeks (Pearson Chi-square test = 7.065, df = 2, Asymp.sig. (2-Sided) = 0.029). Hematomas were associated with significantly higher rates of miscarriages (25.8%) in contrast to a rate of 10.2% amongst women without hematomas  (Pearson Chi-square test = 6.990, df = 2, Asymp.sig. (2-Sided) = 0.030). Conclusions: Moderate to heavy vaginal bleeding, a gestational age of less than 7 weeks and the demonstration of a haematoma on ultrasound scan are associated with significantly higher rates of miscarriage. Higher parity and recurrent miscarriages are associated with increased risk of miscarriage

A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy

BACKGROUND Bleeding in early pregnancy is strongly associated with pregnancy loss. Progesterone is essential for the maintenance of pregnancy. Several small trials have suggested that progesterone therapy may improve pregnancy outcomes in women who have bleeding in early pregnancy. METHODS We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate progesterone, as compared with placebo, in women with vaginal bleeding in early pregnancy. Women were randomly assigned to receive vaginal suppositories containing either 400 mg of progesterone or matching placebo twice daily, from the time at which they presented with bleeding through 16 weeks of gestation. The primary outcome was the birth of a live-born baby after at least 34 weeks of gestation. The primary analysis was performed in all participants for whom data on the primary outcome were available. A sensitivity analysis of the primary outcome that included all the participants was performed with the use of multiple imputation to account for missing data. RESULTS A total of 4153 women, recruited at 48 hospitals in the United Kingdom, were randomly assigned to receive progesterone (2079 women) or placebo (2074 women). The percentage of women with available data for the primary outcome was 97% (4038 of 4153 women). The incidence of live births after at least 34 weeks of gestation was 75% (1513 of 2025 women) in the progesterone group and 72% (1459 of 2013 women) in the placebo group (relative rate, 1.03; 95% confidence interval [CI], 1.00 to 1.07; P=0.08). The sensitivity analysis, in which missing primary outcome data were imputed, resulted in a similar finding (relative rate, 1.03; 95% CI, 1.00 to 1.07; P=0.08). The incidence of adverse events did not differ significantly between the groups. CONCLUSIONS Among women with bleeding in early pregnancy, progesterone therapy administered during the first trimester did not result in a significantly higher incidence of live births than placebo. (Funded by the United Kingdom National Institute for Health Research Health Technology Assessment program; PRISM Current Controlled Trials number, ISRCTN14163439. opens in new tab.

Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: In women with late preterm pre-eclampsia, the optimal time to initiate delivery is unclear because limitation of maternal disease progression needs to be balanced against infant complications. The aim of this trial was to determine whether planned earlier initiation of delivery reduces maternal adverse outcomes without substantial worsening of neonatal or infant outcomes, compared with expectant management (usual care) in women with late preterm pre-eclampsia. Methods: In this parallel-group, non-masked, multicentre, randomised controlled trial done in 46 maternity units across England and Wales, we compared planned delivery versus expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia from 34 to less than 37 weeks' gestation and a singleton or dichorionic diamniotic twin pregnancy. The co-primary maternal outcome was a composite of maternal morbidity or recorded systolic blood pressure of at least 160 mm Hg with a superiority hypothesis. The co-primary perinatal outcome was a composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence). Analyses were by intention to treat, together with a per-protocol analysis for the perinatal outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN01879376. The trial is closed to recruitment but follow-up is ongoing. Findings: Between Sept 29, 2014, and Dec 10, 2018, 901 women were recruited. 450 women (448 women and 471 infants analysed) were allocated to planned delivery and 451 women (451 women and 475 infants analysed) to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group (289 [65%] women) compared with the expectant management group (338 [75%] women; adjusted relative risk 0·86, 95% CI 0·79–0·94; p=0·0005). The incidence of the co-primary perinatal outcome by intention to treat was significantly higher in the planned delivery group (196 [42%] infants) compared with the expectant management group (159 [34%] infants; 1·26, 1·08–1·47; p=0·0034). The results from the per-protocol analysis were similar. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group. Interpretation: There is strong evidence to suggest that planned delivery reduces maternal morbidity and severe hypertension compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater neonatal morbidity. This trade-off should be discussed with women with late preterm pre-eclampsia to allow shared decision making on timing of delivery. Funding: National Institute for Health Research Health Technology Assessment Programme