Every day, 810 women die from preventable causes related to pregnancy and childbirth.(1)
•Hypertensive disorders of pregnancy, including pre-eclampsia, are one of the leading causes of maternal death, and responsible for approximately 500,000 perinatal deaths every year.(2)
•The majority (94%) of these deaths occur in low or middle-income countries.(1)
•Evidence from high-income settings has shown that planned delivery from 34 weeks of pregnancy, in women with pre-eclampsia without severe features, reduces adverse maternal outcomes. This was balanced against an increase in neonatal unit admissions.(3)
•Evidence to guide clinical practice in a low or middle-income setting, is lacking.
•We aimed to evaluate planned delivery, compared to expectant management, for late preterm pre-eclampsia in India and Zambia.
References:
(1) World Health Organisation. Trends in maternal mortality 2000 to 2017: estimates by WHO, UNICEF, UNFPA, World Bank Group and the United Nations Population Division. 2019. https://www.who.int/publications/i/item/9789241516488.
(2) Lawn JE, Blencowe H, Waiswa P, et al. Stillbirths: rates, risk factors, and acceleration towards 2030. Lancet 2016; 387: 587–603
(3) Chappell LC, Brocklehurst P, Green ME, et al. Planned early delivery or expectant management for late preterm pre-eclampsia (PHOENIX): a randomised controlled trial. The Lancet 2019; 394(10204): 1181‐90.
This trial took place across 9 central sites in India (Karnataka state) and Zambia (Lusaka, Central, and Copperbelt provinces).
•A pregnant woman was eligible if she had a clinical diagnosis of pre-eclampsia and a gestational age between 34+0 and 36+6 as confirmed by a doctor, with a singleton or multi-fetal pregnancy, and at least one viable fetus.
•After providing written consent, women were randomly allocated to either planned delivery (initiation of delivery within 48 hours of randomisation), or to expectant management (watching and waiting until reaching 37 weeks’ gestation, or a complication develops necessitating delivery).
•Short-term clinical outcomes were collected up until primary hospital discharge
•The co-primary maternal outcome was a composite of maternal mortality and morbidity based on miniPIERS(1) outcomes with the addition of severe hypertension.
•The co-primary perinatal outcome was a composite of stillbirth, neonatal death, or neonatal unit admission for > 48 hours.
References:
(1) Payne BA, Hutcheon JA, Ansermino JM, et al. A risk prediction model for the assessment and triage of women with hypertensive disorders of pregnancy in low-resourced settings: the miniPIERS (Pre-eclampsia Integrated Estimate of Risk) multi-country prospective cohort study. PLoS Med 2014; 11: e1001589.
Between Dec 19, 2019 and March 31, 2022, 565 women were enrolled. 284 women (282 women and 301 infants analysed) were allocated to planned delivery and 281 women (280 women and 300 infants analysed) allocated to expectant management.
Planned delivery
•Significant reduction in stillbirth (RR 0·25, 95% CI 0·07 to 0·87)
•Significant reduction in severe maternal hypertension (RR 0·83, 95% CI 0·70 to 0·99)
•Reduction (not reaching significance) in overall maternal morbidity and mortality (RR 0·91, 95% CI 0·79 to 1·05)
•No increase in neonatal morbidity or neonatal unit admissions
•No increase in operative delivery
Expectant management
Increased hospital stay (Mean Difference -1.81 [-2.88 to -0.74, p<0.0001]
Lower birthweight centile (Median birthweight centile 22.8 in planned delivery group compared to 16.9 in expectant management group, Median difference 4.4 [IQR 0.5 to 8.8, p=0.003])
Conclusion
It is safe to offer planned delivery to women with late preterm pre-eclampsia, in a low or lower middle-income country setting. Planned delivery reduces stillbirth,with no increase in neonatal unit admissions or neonatal morbidity and reduces the risk of severe maternal hypertension. It should therefore be considered as an intervention to reduce pre-eclampsia associated mortality and morbidity in these settings.
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.
participant STORIES
We asked women who took part in the trial to share their lived experience of pre-eclampsia with us; here are some of their stories…
“I was having high blood pressures and the baby died because I took long to come to the hospital despite me not feeling well during the said pregnancy. I came to this same clinic to have myself checked since I wasn’t feeling too well and the nurse said that am just fine but when I insisted that I am not feeling the baby then I was checked and the nurse said that the baby was in breech and that they were calling the ambulance to come and take me to the main hospital but by the time the ambulance was coming I had already delivered a still born baby. So, I never wanted that to repeat itself.”
Kitwe
CRADLE-4 Participant
“At first it was strange I was scared saying maybe am going to have the similar experience I had in 2010 because that one I used to lead to convulsions. So, I was scared at first but after I came I started with the clinic here the first time, I started with the clinic then referred to the hospital. Now, everything was explained to me just okay and they welcomed me well, at least I was at peace very much at peace.”
Kabwe
CRADLE-4 Participant
“I was scared, I didn’t know what to do, the baby seemed too small until they showed me how to take care of the baby and how to feed it, and hold the baby.”
Ndola
CRADLE-4 Participant
“We want to be healed. So that our babies can also be helped.”
Lusaka
CRADLE-4 Participant
“If I delivered late, there would be a risk to my life. So, it is a good thing that I delivered early. I felt good about it.
I was very frightened. I was afraid how things would turn out. Out of fear, I told them to deliver me by Caesarean section so that I get past the trouble quickly. But they said that I could deliver vaginally and that they would see me through safely. I was happy that everything went well.”
India (Hubli)
CRADLE-4 Participant
“The advice I can give is that, the moment they realize that they are found with hypertension during pregnancy it’s better they go the hospital early, if it was not going to the hospital, it could have been a different story, maybe I could have died so it’s better when they notice that they are not feeling well, they are not okay during pregnancy its better you go early to the hospital so that they are assisted. At least I had found help on time rather staying at home, they can say that I will be fine yet things are getting worse? So it’s better they are aware early so that they can go to the hospital and it’s at the hospital where we find help.”
Kabwe
CRADLE-4 Participant
VISUAL MINUTES
International Collaborator Meeting August 2022
TRIAL LOCATIONS
