NCT03673709

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. We simultaneously identify the degree of implementation success and the contextual factors associated with success across 6 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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,887

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

4.1 years

First QC Date

September 13, 2018

Last Update Submit

January 10, 2025

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (2)

  • Preterm birth

    Newborn born early

    8 weeks postpartum

  • Partner HIV Test

    Proportion of partners tested during this pregnancy

    Enrollment, 36-42 weeks gestation

Secondary Outcomes (16)

  • Spontaneous abortion

    36-42 weeks gestation

  • Stillbirth

    8 weeks postpartum

  • Low birthweight

    8 weeks postpartum

  • Neonatal death

    8 weeks postpartum

  • Maternal death

    8 weeks postpartum, 6 months postpartum

  • +11 more secondary outcomes

Study Arms (2)

Individual Antenatal Care (usual care)

NO INTERVENTION

Women 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 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)

EXPERIMENTAL

Women 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.

Behavioral: Antenatal Care

Interventions

Antenatal CareBEHAVIORAL

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.

Group Antenatal Care (intervention)

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (6)

Bangwe HC

Blantyre, Malawi

Location

Chileka HC

Blantyre, Malawi

Location

Chilomoni HC

Blantyre, Malawi

Location

Limbe HC

Blantyre, Malawi

Location

Lirangwe HC

Blantyre, Malawi

Location

Madziabango HC

Blantyre, Malawi

Location

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: 40531963DERIVED

  • Liese 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: 33098114DERIVED

  • Chirwa 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

Premature Birth

Interventions

Prenatal Care

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsMaternal Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Crystal L Patil, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

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
Associate 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

January 13, 2025

Record last verified: 2025-01

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.

Locations

MA(6)