Evidence map›Paper›PMID 37393919›Full record

Trial reportLancet (London, England)2023

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.

Alice Beardmore-Gray, Nicola Vousden, Paul T Seed, Bellington Vwalika, Sebastian Chinkoyo, Victor Sichone, Alexander B Kawimbe, Umesh Charantimath, Geetanjali Katageri, Mrutyunjaya B Bellad and 8 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in Lancet (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
11.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

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  13. The Escalating Inequalities in Global Maternal Mortality-Time to Act: A Commentary.BJOG : an international journal of obstetrics and gynaecology · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 9 institutions in 3 countries.

Alice Beardmore-GrayDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK. Electronic address: alice.1.beardmore-gray@kcl.ac.uk.
Nicola VousdenDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.
Paul T SeedDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.
Bellington VwalikaDepartment of Obstetrics and Gynaecology, University of Zambia, Lusaka, Zambia.
Sebastian ChinkoyoDepartment of Obstetrics and Gynaecology, Ndola Teaching Hospital, Ndola, Zambia.
Victor SichoneDepartment of Obstetrics and Gynaecology, Kitwe Teaching Hospital, Kitwe, Zambia.
Alexander B KawimbeDepartment of Obstetrics and Gynaecology, Kabwe General Hospital, Kabwe, Zambia.
Umesh CharantimathWomen's and Children's Health Research Unit, KLE Academy of Higher Education and Research, J N Medical College, Belagavi, Karnataka, India.
Geetanjali KatageriS Nijalingappa Medical College and Hangal Shri Kumareshwar Hospital and Research Centre, Bagalkot, Karnataka, India.
Mrutyunjaya B BelladWomen's and Children's Health Research Unit, KLE Academy of Higher Education and Research, J N Medical College, Belagavi, Karnataka, India.
Laxmikant LokareKarnataka Institute of Medical Sciences, Hubballi, Karnataka, India.
Kasturi DonimathKarnataka Institute of Medical Sciences, Hubballi, Karnataka, India.
Shailaja BidriBijapur Lingayat District Educational Association (Deemed to be University), Shri B M Patil Medical College Hospital and Research Centre, Bijapur, India.
Shivaprasad GoudarWomen's and Children's Health Research Unit, KLE Academy of Higher Education and Research, J N Medical College, Belagavi, Karnataka, India.
Jane SandallDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.
Lucy C ChappellDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.
Andrew H ShennanDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.
CRADLE-4 Study Group
King's College London · GBKLE University · INKarnataka Institute of Medical Sciences · INKwame Nkrumah University · ZMNorthrise University · ZMShri BM Patil Medical College · INS Nijalingappa Medical College and HSK Hospital & Research Centre · INUniversity of Zambia · ZMZambia Forestry College · ZM

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPre-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

methodsIn this parallel-group, multicentre, open-label, randomised controlled trial, we compared planned delivery versus expectant management in women with pre-eclampsia from 34

findingsBetween 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.

interpretationClinicians 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.

fundingUK Medical Research Council and Indian Department of Biotechnology.

Indexed as

HypertensionPerinatal DeathPre-EclampsiaPremature BirthDeveloping CountriesFemaleHumansInfant, NewbornPregnancyStillbirthWatchful Waiting

Identifiers

PMID37393919
PMCPMC11667733
OpenAlexW4382600538

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.