Evidence map›Paper›PMID 40306997›Full record

ArticleBMJ open2025

Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in Kenya.

John M Humphrey, Audrey Chepkemoi, Steven Brown, James G Carlucci, Molly McPheron, Caroline Kerich, Winnie Matelong, Harold Kooreman, Megan S McHenry, Caitlin Bernard and 7 more

Abstract read
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

John M HumphreyDepartment of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA humphrjm@iu.edu.ORCID http://orcid.org/0000-0003-3156-1065
Audrey ChepkemoiDepartment of Pediatrics, Moi Teaching and Referral Hospital, Eldoret, Kenya.
Steven BrownDepartment of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
James G CarlucciDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Molly McPheronDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Caroline KerichAcademic Model Providing Access to Healthcare, Eldoret, Kenya.
Winnie MatelongAcademic Model Providing Access to Healthcare, Eldoret, Kenya.
Harold KooremanDepartment of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Megan S McHenryDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.ORCID http://orcid.org/0000-0001-6753-0928
Caitlin BernardDepartment of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Marylydia KianoAcademic Model Providing Access to Healthcare, Eldoret, Kenya.
Beverly S MusickDepartment of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Constantin T YiannoutsosDepartment of Biostatistics, Indiana University Richard M Fairbanks School of Public Health, Indianapolis, Indiana, USA.
Kara Wools-KaloustianDepartment of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Rena C PatelDepartment of Medicine, The University of Alabama Heersink School of Medicine, Birmingham, Alabama, USA.
Edwin WereDepartment of Reproductive Health, Moi University College of Health Sciences, Eldoret, Kenya.
EA-IeDEA consortium

Funding

East Africa International Epidemiology Database to evaluate AIDS (IeDEA) Regional ConsortiumU01AI069911 · NIAID · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI Leslie Anne Enane, AGGREY SEMWENDERO SEMEERE · 2006 to 2026
$57.7M
NIAID NIH HHS U01 AI069911
6 · The paper itself

Abstract

purposePharmacovigilance (PV) systems to assess the safety of antiretroviral treatment used periconception and during pregnancy are lacking in low-resource settings with high HIV burdens, and strategies to guide their implementation are limited. We implemented the Measuring Adverse Pregnancy and Newborn Congenital Outcomes (MANGO) study in Kenya to address these gaps.

participantsIn MANGO, we ascertained delivery outcomes for pregnant women living with HIV (WLH) and not living with HIV (WNLH) enrolled in care at Moi Teaching and Referral Hospital (MTRH) through two cohorts: C1, a prospective cohort of 1:1 matched WLH and WNLH attending antenatal clinic; and C2, a cross-sectional cohort of all deliveries, including among those who did not attend antenatal clinic at MTRH. FINDINGS TO DATE: 24 205 deliveries were recorded from October 2020 to September 2023 (853 in C1 and 23 352 in C2). Median maternal age was 32 years, 4.5% were WLH and 2.6% of deliveries were stillbirths. Among liveborn infants, 17.2% were preterm (<37 weeks), and 15.1% were low birth weight (<2.5 kg). Prevalence of ≥1 major congenital abnormality was 73.9/10 000 births (47.7 in C1 and 76.1 in C2). Assessing implementation barriers/facilitators, lack of national PV policy was a barrier overcome through establishing partnerships with the Kenya Ministry of Health. The facility's size and complexity were barriers to newborn surface exam coverage overcome through staff training and cocreation of a standardised form for newborn surface exam documentation. High staff turnover was addressed by involving head nurses to champion implementation and incentivising staff participation with medical education credits. Use of audit/feedback cycles and focusing on PV as a way to improve care quality facilitated PV institutionalisation at MTRH. FUTURE PLANS: The MANGO model is a multifaceted strategy with replicative potential in other settings. Research is needed to understand the model's opportunities for implementation in other settings.

Indexed as

HIV InfectionsPregnancy Complications, InfectiousPregnancy OutcomeAdultCross-Sectional StudiesFemaleHumansInfant, NewbornKenyaPregnancyProspective StudiesStillbirthYoung AdultAdverse eventsEPIDEMIOLOGIC STUDIESHIV & AIDSImplementation ScienceMEDICAL EDUCATION & TRAININGPregnancy

Identifiers

PMID40306997
PMCPMC12049888

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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.