Planned Delivery or Expectant Management for Late Preterm Pre-eclampsia in Low-Income and Middle-Income Countries (CRADLE-4): A Multicentre, Open-Label, Randomized Controlled Trial

Mon, 01 Jan 2024 00:00:00 GMT

Planned Delivery or Expectant Management for Late Preterm Pre-eclampsia in Low-Income and Middle-Income Countries (CRADLE-4): A Multicentre, Open-Label, Randomized Controlled Trial Shailaja Bidri Background Pre-eclampsia is a leading cause of maternal and perinatal mortality. Evidence regarding interventions in a low-income or middle-income setting is scarce. We aimed to evaluate whether planned delivery between 34+ ⁰ and 36+ ⁶ weeks’ gestation can reduce maternal mortality and morbidity without increasing perinatal complications in India and Zambia. Methods In this parallel-group, multicentre, open-label, randomised controlled trial, we compared planned delivery versus expectant management in women with pre-eclampsia from 34+ ⁰ to 36+ ⁶ weeks’ gestation. Participants were recruited from nine hospitals and referral facilities in India and Zambia and randomly assigned to planned delivery or expectant management in a 1:1 ratio by a secure web-based randomisation facility hosted by MedSciNet. Randomisation was stratified by centre and minimised by parity, single-fetus pregnancy or multi-fetal pregnancy, and gestational age. The primary maternal outcome was a composite of maternal mortality or morbidity with a superiority hypothesis. The primary perinatal outcome was a composite of one or more of: stillbirth, neonatal death, or neonatal unit admission of more than 48 h with a non-inferiority hypothesis (margin of 10% difference). Analyses were by intention to treat, with an additional per-protocol analysis for the perinatal outcome. The trial was prospectively registered with ISRCTN, 10672137. The trial is closed to recruitment and all follow-up has been completed. Findings Between Dec 19, 2019, and March 31, 2022, 565 women were enrolled. 284 women (282 women and 301 babies analysed) were allocated to planned delivery and 281 women (280 women and 300 babies analysed) were allocated to expectant management. The incidence of the primary maternal outcome was not significantly different in the planned delivery group (154 [55%]) compared with the expectant management group (168 [60%]; adjusted risk ratio [RR] 0·91, 95% CI 0·79 to 1·05). The incidence of the primary perinatal outcome by intention to treat was noninferior in the planned delivery group (58 [19%]) compared with the expectant management group (67 [22%]; adjusted risk difference –3·39%, 90% CI –8·67 to 1·90; non-inferiority p<0·0001). The results from the per-protocol analysis were similar. There was a significant reduction in severe maternal hypertension (adjusted RR 0·83, 95% CI 0·70 to 0·99) and stillbirth (0·25, 0·07 to 0·87) associated with planned delivery. There were 12 serious adverse events in the planned delivery group and 21 in the expectant management group. Interpretation Clinicians can safely offer planned delivery to women with late preterm pre-eclampsia, in a low-income or middle-income country. Planned delivery reduces stillbirth, with no increase in neonatal unit admissions or neonatal morbidity and reduces the risk of severe maternal hypertension. Planned delivery from 34 weeks’ gestation should therefore be considered as an intervention to reduce pre-eclampsia associated mortality and morbidity in these settings.

Unveiling histopathological alterations in placentas of pregnant women affected by Covid-19: A comprehensive analysis

Sun, 01 Jan 2023 00:00:00 GMT

Unveiling histopathological alterations in placentas of pregnant women affected by Covid-19: A comprehensive analysis Sangamesh Mathapati, Mamatha K, Laxmi Sangolli, Aruna Biradar, Sannidhi.

Prurigo of pregnancy.

Sun, 01 Jan 2023 00:00:00 GMT

Prurigo of pregnancy. Rajasri Gurulingappa Yaliwal, Aruna Biradar, Ashwini Konin, Sona Tejaswi Reddy.

Use of intramyometrial carbetocin in caesarean myomectomy to reduce hemorrhage.

Sun, 01 Jan 2023 00:00:00 GMT

Use of intramyometrial carbetocin in caesarean myomectomy to reduce hemorrhage. Rajasri G Yaliwal, Shilpa Lakshmi, Aruna M Biradar, Laxmi S Sangolli, Gauri Bankapur.

Faculty of OBG

Planned Delivery or Expectant Management for Late Preterm Pre-eclampsia in Low-Income and Middle-Income Countries (CRADLE-4): A Multicentre, Open-Label, Randomized Controlled Trial

Unveiling histopathological alterations in placentas of pregnant women affected by Covid-19: A comprehensive analysis

Prurigo of pregnancy.

Use of intramyometrial carbetocin in caesarean myomectomy to reduce hemorrhage.