Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
2 other identifiers
interventional
1,887
1 country
7
Brief Summary
In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care (Aim 1) across 7 antenatal clinics in Blantyre District, Malawi. If results are negative, governments will avoid spending on ineffective care. Positive maternal, neonatal and HIV-related outcomes of group antenatal care will save lives, impact the cost and quality of antenatal care, and influence health policy as governments adopt this innovative model of care nationally.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2018
CompletedFirst Posted
Study publicly available on registry
September 17, 2018
CompletedStudy Start
First participant enrolled
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedResults Posted
Study results publicly available
July 13, 2026
CompletedJuly 13, 2026
June 1, 2026
4.1 years
September 13, 2018
May 31, 2025
June 15, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Born Weighing Less Than 2500 g
Whether a newborn weighed \<2,500 grams at birth (yes/no) is used as a proxy for preterm birth due to the lack of accurate gestational age data.
8 weeks postpartum
Partner HIV Test
Proportion of partners tested during this pregnancy
36-42 weeks gestation
Secondary Outcomes (14)
Spontaneous Abortion
36-42 weeks gestation
Stillbirth
8 weeks postpartum
Infant Death
6 months postpartum
Maternal Death
6 months postpartum
Anemia
36-42 weeks gestation
- +9 more secondary outcomes
Study Arms (2)
Individual Antenatal Care (usual care)
NO INTERVENTIONWomen are provided antenatal care services on a first come, first serve basis and listen to a health lecture. They meet individually with a midwife for a physical assessment. Women complete laboratory tests (including HIV testing) at their first visit. Congruent with the new World Health Organization (WHO) recommendations, individual antenatal care consists of 8 antenatal care visits and 2 postnatal visits at 1 week and 6 weeks.
Group Antenatal Care (intervention)
EXPERIMENTALWomen have the same number of visits as those in individual care. Their first antenatal care (intake) and first postnatal visit is done individually (identical to individual care). Women in group care bypass the waiting area and have a 2-hour visit with the same provider in a group of 8-12 women at a similar stage of pregnancy. Women assess their blood pressure and weight, briefly consult the midwife in a corner of the room, and meet for 80-90 minutes of interactive health promotion, enlivened by games and role-plays.
Interventions
Women in group care bypass the waiting room and have a 2-hour visit with the same provider with a group of 8-12 women at a similar stage of pregnancy. Women assess their own blood pressure and weight, briefly consult the midwife in a corner of the room, and meet for 80-90 minutes of interactive health promotion, enlivened by games and role-plays.
Eligibility Criteria
You may qualify if:
- Pregnant, 24 weeks gestation or less, no marked cognitive impairment, speaks and understands Chichewa (the national language)
You may not qualify if:
- Not pregnant, more than 24 weeks gestation, marked cognitive impairment, does not speak or understand Chichewa (the national language)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- University of Malawicollaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (7)
Bangwe HC
Blantyre, Malawi
Chileka HC
Blantyre, Malawi
Chilomoni HC
Blantyre, Malawi
Limbe HC
Blantyre, Malawi
Lirangwe HC
Blantyre, Malawi
Madziabango HC
Blantyre, Malawi
Ndirande HC
Blantyre, Malawi
Related Publications (3)
Patil CL, Norr KF, Kapito E, Liu LC, Mei X, Chodzaza E, Chorwe-Sungani G, Kafulafula U, Abrams ET, Desloge A, Gresh A, Jeremiah RD, Patel DR, Batchelder A, Wang H, Faydenko J, Rising SS, Chirwa E. Group antenatal care positively transforms the care experience: Results of an effectiveness trial in Malawi. PLoS One. 2025 Jun 18;20(6):e0317171. doi: 10.1371/journal.pone.0317171. eCollection 2025.
PMID: 40531963RESULTLiese KL, Kapito E, Chirwa E, Liu L, Mei X, Norr KF, Patil CL. Impact of group prenatal care on key prenatal services and educational topics in Malawi and Tanzania. Int J Gynaecol Obstet. 2021 Apr;153(1):154-159. doi: 10.1002/ijgo.13432. Epub 2020 Dec 2.
PMID: 33098114DERIVEDChirwa E, Kapito E, Jere DL, Kafulafula U, Chodzaza E, Chorwe-Sungani G, Gresh A, Liu L, Abrams ET, Klima CS, McCreary LL, Norr KF, Patil CL. An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi. BMC Public Health. 2020 Feb 10;20(1):205. doi: 10.1186/s12889-020-8276-x.
PMID: 32039721DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We originally intended to assess the impact of Group ANC on preterm birth rates, which requires an accurate assessment of gestational age at birth. After integrating all available data from health records and women's reports (i.e., last menstrual period, midwife assessments, and ultrasound results), we were still unable to obtain a reliable measure of gestational age at birth, even when ultrasound results were available. Therefore, we opted to use low birth weight as a proxy for this outcome
Results Point of Contact
- Title
- Dr. Crystal Patil
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Crystal L Patil, PhD
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The research team working on the effectiveness evaluation of group care is blinded to study condition and is charged with collecting the Aim 1 effectiveness data from the individuals.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 13, 2018
First Posted
September 17, 2018
Study Start
July 5, 2019
Primary Completion
August 10, 2023
Study Completion
May 31, 2024
Last Updated
July 13, 2026
Results First Posted
July 13, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
De-identified data will be made available to other researchers for secondary analyses after the primary outcome publications have been accepted for publication, approximately 3 years after the grant ends.