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Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi

Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03673709
Enrollment
1887
Registered
2018-09-17
Start date
2019-07-05
Completion date
2024-05-31
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

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.

Detailed description

Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for 2/3 of new HIV infections and 1/4 of preterm births. Antenatal (prenatal) care is the entry point into the health system for many women and offers a unique opportunity to provide life-saving monitoring. However, provider shortages, low quality of care and failure to attend all recommended visits mean that the potential benefits of antenatal care are not realized. There is an urgent need to test novel interventions to reduce health risks for mother and child. Group antenatal care is a transformative model of care that provides a positive pregnancy experience, uses provider time efficiently, and improves perinatal and HIV-related outcomes. Women in group antenatal care have 2-hour visits with the same provider in a group of 8-12 women at a similar stage of pregnancy. Women conduct self-assessments, briefly consult the midwife, and meet for 80-90 minutes of interactive health promotion enlivened by games and role-plays. Women form relationships with midwives and each other. In a US randomized clinical trial (RCT), group care improved prematurity rates, antenatal care attendance, satisfaction with care, breastfeeding practices, safer sex behaviors, and uptake of family planning. Our randomized pilot in Malawi and Tanzania had promising outcomes. More women in group care than in usual care completed ≥4 antenatal visits (94% vs 58%). Their partners were more likely to be tested for HIV during pregnancy (51% vs. 27%). We established that group antenatal care can be offered in a rigorous RCT with high fidelity despite provider shortages. The next step is an adequately powered effectiveness trial. Malawi is an especially appropriate site because it has the world's highest prematurity rate (18%) and high HIV prevalence (10% nationally, 16% at the study site). We conducted an effectiveness RCT with individual-level randomization. Aim 1 is to evaluate the effectiveness of group antenatal care through 6 months postpartum. We hypothesize that compared to usual care, women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We test Aim 1 hypotheses using multi-level hierarchical models using data from repeated surveys and health records. This high-impact study addresses three global health priorities, maternal and infant mortality and HIV prevention, that affect all women of childbearing age in Malawi. The Ministry of Health strongly supports this project; results will help them decide whether to scale-up this innovative model of group care. Negative results will avoid spending on ineffective care. Positive results will provide evidence needed to adopt group antenatal care nationally and in other low-resource countries.

Interventions

BEHAVIORALAntenatal Care

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.

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER
University of Malawi
CollaboratorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pregnant, 24 weeks gestation or less, no marked cognitive impairment, speaks and understands Chichewa (the national language)

Exclusion criteria

* Not pregnant, more than 24 weeks gestation, marked cognitive impairment, does not speak or understand Chichewa (the national language)

Design outcomes

Primary

MeasureTime frameDescription
Born Weighing Less Than 2500 g8 weeks postpartumWhether 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.
Partner HIV Test36-42 weeks gestationProportion of partners tested during this pregnancy

Secondary

MeasureTime frameDescription
Spontaneous Abortion36-42 weeks gestationPregnancy loss less than 20 weeks
Stillbirth8 weeks postpartumBaby born with no signs of life at or after 28 weeks gestational age
Infant Death6 months postpartumInfant death before the end of the study
Maternal Death6 months postpartumMaternal death before the end of the study
Anemia36-42 weeks gestationHemoglobin level of \<11 g/dl
Family Planning6 months postpartumReported use of family planning at late postpartum, approximately 6 months after delivery
Exclusive Breastfeeding6 months postpartumExclusive breastfeeding for six months (yes)
Self Reporting Questionnaire (SRQ)8 weeks postpartumSelf-Reporting Questionnaire has 20 yes/no items that screen for symptoms of anxiety, depression, psychosomatic symptoms, reduced vital energy, and depressive thoughts. Score range is a minimum of 0 and a maximum of 20 for a total score; a higher score indicates higher distress.
Satisfaction With Antenatal Care (ANC)36-42 weeks gestationA 10-item scale rating satisfaction with the overall quality of the care, the procedures, providers' level of respect and listening skills, with response options of a 5-point Likert scale ("1= Poor; 2= Fair; 3= Good; 4= Very good; 5= Excellent). The range is 10-50, with higher scores indicating greater satisfaction with care.
Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct36-42 weeks gestationJoint United Nations Programme on HIV/AIDS (UNAIDS) comprehensive HIV prevention knowledge measured as whether the person answered all five questions correctly: if a healthy-looking person can have HIV, whether condom use and having only one uninfected partner reduce the likelihood of getting HIV transmission and two of the most common local misconceptions about HIV transmission (casual contact and mosquito bites).
Mean Antenatal Care (ANC) Contacts8 weeks postpartumMean number of antenatal care (ANC) contacts. Minimum is 1 since all participants were recruited at their first contact, and maximum is unlimited, but 8 was the ecommended number of contacts
Pregnancy-related Empowerment Scale (PRES)36 to 42 weeks gestationThe 16-item Likert-type scale with 1 (strongly disagree) to 4 (strongly agree) capturing a sense of control over pregnancy health and healthcare across four domains: provider connectedness, skillful decision-making, peer connectedness, and gaining voice; range 16-64 with a higher score indicating feeling more empowerment.
Wait Time36-42 weeks gestationWaited less than one hour for antenatal care (ANC) services (% yes)
Prefer Group Antenatal Care (ANC) in the Future36-42 weeks gestationIn late pregnancy, participants were asked if they would prefer individual or group antenatal care (ANC) if pregnant in the future (% preferring group ANC).

Countries

Malawi

Contacts

PRINCIPAL_INVESTIGATORCrystal L Patil, PhD

University of Illinois at Chicago

Participant flow

Recruitment details

Data were collected between 5 July 2019 and 10 August 2023, comparing outcomes for pregnant women randomly assigned to Group ANC or Individual ANC at seven clinics in Blantyre District, Malawi. The sample size was 1887 for the detection of a reduced preterm birth rate from 18% in the individual care arm to 12% in the Group ANC arm, controlling for 80% statistical power and 30% retention

Baseline characteristics

Characteristic
Age, Customized
15-19 years
496 Participants
Age, Customized
20-29 years
1115 Participants
Age, Customized
30-35 years
276 Participants
Education category
Completed primary
767 Participants
Education category
Less than primary
414 Participants
Education category
More than primary
133 Participants
Experienced Food Insecurity in last 12 months
No, Did Not Experience Food Insecurity in last 12 months
292 Participants
Experienced Food Insecurity in last 12 months
Yes, Did Experience Food Insecurity in last 12 months
649 Participants
In a relationship (married, living with a partner, or dating)
In a relationship (married, living with a partner, or dating)
886 Participants
In a relationship (married, living with a partner, or dating)
Not In a relationship (married, living with a partner, or dating)
127 Participants
Ownership Index (0-3)
0 items owned
370 Participants
Ownership Index (0-3)
1 item owned
454 Participants
Ownership Index (0-3)
2 items owned
271 Participants
Ownership Index (0-3)
3 items owned
41 Participants
Ownership Index (0-3)
Missing
0 Participants
Pregnant for the first time (\primiparous)774 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
941 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
Malawi
941 participants
Sex: Female, Male
Female
941 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 94116 / 8151 / 94622 / 848
other
Total, other adverse events
0 / 9410 / 8150 / 9460 / 848
serious
Total, serious adverse events
0 / 9410 / 8150 / 9460 / 848

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026