Planned delivery or expectant management for late preterm pre-eclampsia in low-income and middle-income countries (CRADLE-4): a multicentre, open-label, randomised controlled trial

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 non-inferior 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. / Funding: UK Medical Research Council and Indian Department of Biotechnology

Attitude towards COVID-19 Vaccine among Pregnant Women: Sikap terhadap Vaksinasi COVID-19 di kalangan Ibu Hamil

Objective: To assess the perceptions and intentions of pregnant women regarding COVID-19 vaccination and to explore the reasons for vaccine hesitancy as well as acceptance. Methods: This prospective cross-sectional study was conducted in tertiary care hospital in Karnataka. Around 811 pregnant women attending the antenatal clinic were recruited into the study. Data were collected using a face-to-face, anonymous questionnaire written in local language.Results: Eighty six point two percent participants were aged 20 to 30 years and 64.6% had completed their schooling. 94.3% of them were homemakers and 58 % of the participants were in their third trimester. 65.5% of study group members lived in a COVID-supportive environment. Participants with COVID-19 vaccination awareness accounted for 87.4% and 65.4% were willing to receive the same whole heartedly. Our study found that 65.4% of participants were willing to receive covid-19 vaccine. The reasons for refusal were Lack of sufficient information regarding the vaccine, may be harmful to foetus and mother and lack of data proving its quality and efficiency.Conclusion: Pregnant women in the North Karnataka region were highly receptive to COVID-19 immunization. Although a high level of awareness was apparent, the lack of data and fear of side effects were two major concerns for refusal. Confidence in the government and the availability of free vaccines for all have demonstrated a massive impact on vaccination. Keywords: antenatal, covid-19, pregnancy, vaccination.AbstrakTujuan: Menilai persepsi dan keinginan perempuan hamil terkait vaksin COVID-19 dan alasan terkait penerimaan dan juga keraguan terhadap vaksin.Metode: Penelitian ini merupakan penelitian potong lintang dengan pendekatan prospektif yang dilakukan di Rumah Sakit Karnataka. Perempuan hamil sebanyak 811 menjadi subjek penelitian. Data dikumpulkan menggunakan kuesioner yang dituliskan dalam Bahasa lokal dan pengumpulan data dilakukan secara tatap muka. Hasil: Sebanyak 86,2 % sampel penelitian berusia 20 hingga 30 tahun dan 64,6% telah lulus sekolah. Sebanyak 94,3% sampel adalah ibu rumah tangga dan 58% dari sampel dengan usia kehamilan pada trimester ketiga. Sebanyak 65,5% grup tinggal pada kondisi. Sebanyak 87,4% sampel sadar akan keutamaan vaksin dan 65,4% bersedia mendapatkan vaksin. Alasan penolakan terhadap vaksin adalah kurangnya pengetahun mengenai vaksin dan ketakutan akan efek sampingnya.Kesimpulan: Perempuan hamil di Karnatakan Utara terbuka terhadap imunisasi COVID-19. Disamping tingginya angka kesadaran akan imunisasi COVID-19, penolakan umumnya didominasi akibat kurangnya pengetahuan dan ketakutan akan efek samping. Keyakinan pada pemerintah dan ketersediaan vaksin secara gratis sangat berpengaruh pada vaksinasi.Kata kunci: antenatal. covid-19, kehamilan, vaksinasi

SCOPE: Surveillance of COVID-19 in pregnancy- results of a multicentric ambispective case-control study on clinical presentation and maternal outcomes in India between April to November 2020.

ObjectiveTo determine the clinical manifestations, risk factors, treatment modalities and maternal outcomes in pregnant women with lab-confirmed COVID-19 and compare it with COVID-19 negative pregnant women in same age group.DesignMulticentric case-control study.Data sourcesAmbispective primary data collection through paper-based forms from 20 tertiary care centres across India between April and November 2020.Study populationAll pregnant women reporting to the centres with a lab-confirmed COVID-19 positive result matched with controls.Data qualityDedicated research officers extracted hospital records, using modified WHO Case Record Forms (CRF) and verified for completeness and accuracy.Statistical analysisData converted to excel files and statistical analyses done using STATA 16 (StataCorp, TX, USA). Odds ratios (ORs) with 95% confidence intervals (CI) estimated using unconditional logistic regression.ResultsA total of 76,264 women delivered across 20 centres during the study period. Data of 3723 COVID positive pregnant women and 3744 age-matched controls was analyzed. Of the positive cases 56·9% were asymptomatic. Antenatal complications like preeclampsia and abruptio placentae were seen more among the cases. Induction and caesarean delivery rates were also higher among Covid positive women. Pre-existing maternal co-morbidities increased need for supportive care. There were 34 maternal deaths out of the 3723(0.9%) positive mothers, while covid negative deaths reported from all the centres were 449 of 72,541 (0·6%).ConclusionCovid-19 infection predisposed to adverse maternal outcomes in a large cohort of Covid positive pregnant women as compared to the negative controls