Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in Kenya
Purpose Pharmacovigilance (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 Ne...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-04-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/4/e092430.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849323639996940288 |
|---|---|
| author | Steven Brown Kara Wools-Kaloustian John M Humphrey Edwin Were Winnie Matelong Rena C Patel James G Carlucci Megan S McHenry Caitlin Bernard Constantin T Yiannoutsos Audrey Chepkemoi Molly McPheron Caroline Kerich Harold Kooreman Marylydia Kiano Beverly S Musick |
| author_facet | Steven Brown Kara Wools-Kaloustian John M Humphrey Edwin Were Winnie Matelong Rena C Patel James G Carlucci Megan S McHenry Caitlin Bernard Constantin T Yiannoutsos Audrey Chepkemoi Molly McPheron Caroline Kerich Harold Kooreman Marylydia Kiano Beverly S Musick |
| author_sort | Steven Brown |
| collection | DOAJ |
| description | Purpose Pharmacovigilance (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.Participants In 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. |
| format | Article |
| id | doaj-art-2406992415a34ba1801f40f1e9b9db07 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-2406992415a34ba1801f40f1e9b9db072025-08-20T03:48:58ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2024-092430Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in KenyaSteven Brown0Kara Wools-Kaloustian1John M Humphrey2Edwin Were3Winnie Matelong4Rena C Patel5James G Carlucci6Megan S McHenry7Caitlin Bernard8Constantin T Yiannoutsos9Audrey Chepkemoi10Molly McPheron11Caroline Kerich12Harold Kooreman13Marylydia Kiano14Beverly S Musick15Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana, USAIndiana University Center for Global Health Equity, Indianapolis, Indiana, USAAcademic Model Providing Access to Healthcare, Eldoret, KenyaAcademic Model Providing Access to Healthcare, Eldoret, KenyaAcademic Model Providing Access to Healthcare (AMPATH), Eldoret, KenyaDepartments of Medicine and Public Health, University of Alabama Birmingham, Birmingham, Alabama, USADepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USAAcademic Model Providing Access to Healthcare, Eldoret, KenyaDepartment of Obstetrics and Gynecology, Indiana University, Bloomington, Indiana, USADepartment of Biostatistics and Health Data Science, Indiana University Richard M Fairbanks School of Public Health, Indianapolis, Indiana, USADepartment of Pediatrics, Moi Teaching and Referral Hospital, Eldoret, KenyaDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USAAcademic Model Providing Access to Healthcare, Eldoret, KenyaDepartment of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana, USAAcademic Model Providing Access to Healthcare, Eldoret, KenyaDepartment of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana, USAPurpose Pharmacovigilance (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.Participants In 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.https://bmjopen.bmj.com/content/15/4/e092430.full |
| spellingShingle | Steven Brown Kara Wools-Kaloustian John M Humphrey Edwin Were Winnie Matelong Rena C Patel James G Carlucci Megan S McHenry Caitlin Bernard Constantin T Yiannoutsos Audrey Chepkemoi Molly McPheron Caroline Kerich Harold Kooreman Marylydia Kiano Beverly S Musick Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in Kenya BMJ Open |
| title | Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in Kenya |
| title_full | Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in Kenya |
| title_fullStr | Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in Kenya |
| title_full_unstemmed | Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in Kenya |
| title_short | Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in Kenya |
| title_sort | cohort profile measuring adverse pregnancy and newborn congenital outcomes mango study in kenya |
| url | https://bmjopen.bmj.com/content/15/4/e092430.full |
| work_keys_str_mv | AT stevenbrown cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT karawoolskaloustian cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT johnmhumphrey cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT edwinwere cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT winniematelong cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT renacpatel cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT jamesgcarlucci cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT megansmchenry cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT caitlinbernard cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT constantintyiannoutsos cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT audreychepkemoi cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT mollymcpheron cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT carolinekerich cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT haroldkooreman cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT marylydiakiano cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya AT beverlysmusick cohortprofilemeasuringadversepregnancyandnewborncongenitaloutcomesmangostudyinkenya |