Neonatal outcomes for women at risk of preterm delivery given half dose versus full dose of antenatal betamethasone: a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial.

BACKGROUND: Antenatal betamethasone is recommended before preterm delivery to accelerate fetal lung maturation. However, reports of growth and neurodevelopmental dose-related side-effects suggest that the current dose (12 mg plus 12 mg, 24 h apart) might be too high. We therefore investigated whether a half dose would be non-inferior to the current full dose for preventing respiratory distress syndrome. METHODS: We designed a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial in 37 level 3 referral perinatal centres in France. Eligible participants were pregnant women aged 18 years or older with a singleton fetus at risk of preterm delivery and already treated with the first injection of antenatal betamethasone (11·4 mg) before 32 weeks' gestation. We used a computer-generated code producing permuted blocks of varying sizes to randomly assign (1:1) women to receive either a placebo (half-dose group) or a second 11·4 mg betamethasone injection (full-dose group) 24 h later. Randomisation was stratified by gestational age (before or after 28 weeks). Participants, clinicians, and study staff were masked to the treatment allocation. The primary outcome was the need for exogenous intratracheal surfactant within 48 h after birth. Non-inferiority would be shown if the higher limit of the 95% CI for the between-group difference between the half-dose and full-dose groups in the primary endpoint was less than 4 percentage points (corresponding to a maximum relative risk of 1·20). Four interim analyses monitoring the primary and the secondary safety outcomes were done during the study period, using a sequential data analysis method that provided futility and non-inferiority stopping rules and checked for type I and II errors. Interim analyses were done in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT02897076. FINDINGS: Between Jan 2, 2017, and Oct 9, 2019, 3244 women were randomly assigned to the half-dose (n=1620 [49·9%]) or the full-dose group (n=1624 [50·1%]); 48 women withdrew consent, 30 fetuses were stillborn, 16 neonates were lost to follow-up, and 9 neonates died before evaluation, so that 3141 neonates remained for analysis. In the intention-to-treat analysis, the primary outcome occurred in 313 (20·0%) of 1567 neonates in the half-dose group and 276 (17·5%) of 1574 neonates in the full-dose group (risk difference 2·4%, 95% CI -0·3 to 5·2); thus non-inferiority was not shown. The per-protocol analysis also did not show non-inferiority (risk difference 2·2%, 95% CI -0·6 to 5·1). No between-group differences appeared in the rates of neonatal death, grade 3-4 intraventricular haemorrhage, stage ≥2 necrotising enterocolitis, severe retinopathy of prematurity, or bronchopulmonary dysplasia. INTERPRETATION: Because non-inferiority of the half-dose compared with the full-dose regimen was not shown, our results do not support practice changes towards antenatal betamethasone dose reduction. FUNDING: French Ministry of Health.

Impact of recommended changes in labor management for prevention of the primary cesarean delivery.

BACKGROUND: The dramatic rise in cesarean delivery rates worldwide in recent decades, without evidence of a concomitant decrease in cerebral palsy rates, has raised concerns about its potential negative consequences for maternal and infant health. In 2014, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine jointly published an Obstetric Care Consensus for safe prevention of the primary cesarean delivery. OBJECTIVE: We sought to assess whether modification of our protocol to implement these recommendations helped to decrease our primary cesarean delivery rate safely. STUDY DESIGN: This is a before-and-after retrospective cohort study at a university referral hospital. In March 2014, the threshold for defining active labor changed from 4 to >6 cm and arrest of first-stage labor from lack of cervical change despite regular contractions after 3 hours of oxytocin administration with amniotomy and epidural anesthesia to no change after 4 hours of adequate or 6 hours of inadequate contractions in women with an epidural. The definition of second-stage arrest of labor changed simultaneously from lack of progress for 3 hours with adequate contractions in women with epidural anesthesia to no progress for ≥4 hours in nulliparas or 3 hours in multiparas with an epidural. We compared maternal and neonatal outcomes over two 1 year periods: from March 2013 to February 2014 (before, preguideline) and from June 2014 to May 2015 (after, postguideline). We included all women with singleton pregnancies at ≥37 weeks' gestation, in vertex presentation, in spontaneous or induced labor, and with epidural anesthesia. We excluded women with an elective or previous cesarean delivery and those with obstetric or fetal complications. RESULTS: This study included 3283 and 3068 women in the before and after periods, respectively. The groups had similar general and obstetric characteristics. The global cesarean delivery rate decreased significantly from 9.4% in the preguideline to 6.9% in the postguideline period (odds ratio, 0.71; 95% confidence interval, 0.59-0.85; P < .01). The cesarean delivery rate for arrest of first-stage labor fell by half, from 1.8% to 0.9% (odds ratio, 0.51; 95% confidence interval, 0.31-0.81; P < .01) but was significant only among nulliparous women. The cesarean delivery rate for second-stage arrest of labor decreased but not significantly between periods (1.3% vs 1.0%; odds ratio, 0.73; 95% confidence interval, 0.44-1.22; P = .2), and the cesarean delivery rate for failure of induction remained similar (3.7% vs 3.5%; odds ratio, 1.06; 95% confidence interval, 0.06-13.24; P = .88). The median duration of labor before cesarean delivery also became significantly longer among nulliparous women during the later period. Maternal and neonatal outcomes did not differ between the 2 periods, except that the rate of 1 minute Apgar score <7 fell significantly in the later period (8.4% vs 6.9%; odds ratio, 0.80; 95% confidence interval, 0.66-0.97; P = .02). CONCLUSION: The modification of our protocol by implementing the new consensus recommendations was associated with a reduction of the rate of primary cesarean delivery performed for arrest of labor with no apparent increase in immediate adverse neonatal outcomes in nulliparous women at term with singleton pregnancies in vertex presentation and with epidural anesthesia. Further studies are needed to assess the long-term maternal and neonatal safety of these policies.

Is sonographic measurement of head-perineum distance useful to predict obstetrical anal sphincter injury in case of vacuum delivery?

OBJECTIVE: Determine if head-perineum distance (HPD) measurement before vacuum extraction (VE) was predictive of an obstetric anal sphincter injury (OASIS) occurrence. METHODS: Retrospective, bicentric (Lille and Poissy, France) cohort study conducted from January 2019 to June 2020. All VE in singleton pregnancies of ≥34 weeks were included. HPD measurement was performed without compression of the tissues before each VE. The judgment criterion was the occurrence of an OASIS. RESULTS: Of 12 568 deliveries, VE was performed in 1093 (8.6%). Among these 1093 women undergoing VE, 675 (61.7%) with HPD measurement were included. OASIS was found in 6.5% of women (n = 44; 95% CI 4.5-8.7). HPD was not associated with OASIS (38.5 ± 12.6 mm in women with OASIS vs 37.4 ± 12.0 mm in women without; adjusted OR [aOR] per 5 mm increase = 0.92; 95% CI 0.79-1.06). Increased HPD was associated with higher risk of sequential extraction (aOR = 1.19; 95% CI 1.06-1.32), extraction duration >10 min (aOR = 1.12; 95% CI 1.02-1.23) and shoulder dystocia (aOR = 1.20; 95% CI 1.03-1.40). CONCLUSION: Ultrasound-measured head-perineum distance does not predict the occurrence of obstetric anal sphincter injury during a VE. The interest of HPD is more about predicting the success or difficulty of VE rather its specific complications.

Malaria in pregnant woman masquerading as HELLP syndrome.

Malaria may be complicated by development of thrombocytopenia, elevated liver enzymes, and/or hemolysis, which may be difficult to distinguish from HELLP (hemolytic anemia; elevated liver enzymes; low platelet count) syndrome in a pregnant patient. A 33-year-old woman developed a HELLP-like syndrome and persistent fever postpartum without symptoms of preeclampsia. A malaria blood smear was performed and was positive for Plasmodium falciparum. The patient was immediately treated with quinine. The follow-up was uneventful with total disappearance of fever and prompt resolution of biochemical signs of HELLP-like syndrome 3 days later. Malaria in a pregnant woman can masquerade as HELLP syndrome. The wide overlap in symptoms (headache, malaise, digestive symptoms) does not suggest that symptoms would be effective in differentiating malaria and preeclampsia. A recent travel in endemic area, associated with malaria blood smear and clinic examination, should be the key of the differential diagnosis.

Pregnancy and delivery in patients with portal vein cavernoma.

BACKGROUND: Portal vein cavernoma (PVC) is a rare disease resulting from extrahepatic portal vein thrombosis and development of collateral venous circulation. The management of pregnancy and delivery in woman with PVC has rarely been described. CASES: Two primiparous women are presented to illustrate the management of PVC during pregnancy and discuss the delivery route according to the symptoms and the PVC complications. The first patient presented PVC associated with large jejunal varices and high anticardiolipid antibodies. She was treated with beta-blocker therapy and low molecular weight heparin during pregnancy, and delivered by cesarean section. The second patient presented protein S deficiency complicated by PVC and thrombocytopenia and delivered vaginally without complications. CONCLUSION: Many issues should be considered when counseling women with PVC, including the management before and during pregnancy according to symptoms and PVC complications. A multidisciplinary approach seems to be key to the management of delivery. Our advice to caregivers is that elective cesarean section seems necessary in cases with digestive varices. Vaginal delivery, with a passive second stage, seems to be relatively safe and less morbid in women without digestive varices, when maternal and fetal tolerance permits.