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Completed

NCT Number: NCT03673709

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

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.

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bangwe HC, Blantyre, Malawi

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Antenatal Care

Behavioral

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.

Primary outcomes

  1. Born Weighing Less Than 2500 g

    Time frame: 8 weeks postpartum

    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.

  2. Partner HIV Test

    Time frame: 36-42 weeks gestation

    Proportion of partners tested during this pregnancy

Secondary outcomes

  1. Spontaneous Abortion

    Time frame: 36-42 weeks gestation

    Pregnancy loss less than 20 weeks

  2. Stillbirth

    Time frame: 8 weeks postpartum

    Baby born with no signs of life at or after 28 weeks gestational age

  3. Infant Death

    Time frame: 6 months postpartum

    Infant death before the end of the study

  4. Maternal Death

    Time frame: 6 months postpartum

    Maternal death before the end of the study

  5. Anemia

    Time frame: 36-42 weeks gestation

    Hemoglobin level of <11 g/dl

  6. Family Planning

    Time frame: 6 months postpartum

    Reported use of family planning at late postpartum, approximately 6 months after delivery

  7. Exclusive Breastfeeding

    Time frame: 6 months postpartum

    Exclusive breastfeeding for six months (yes)

  8. Self Reporting Questionnaire (SRQ)

    Time frame: 8 weeks postpartum

    Self-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.

  9. Satisfaction With Antenatal Care (ANC)

    Time frame: 36-42 weeks gestation

    A 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.

  10. Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct

    Time frame: 36-42 weeks gestation

    Joint 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).

  11. Mean Antenatal Care (ANC) Contacts

    Time frame: 8 weeks postpartum

    Mean 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

  12. Pregnancy-related Empowerment Scale (PRES)

    Time frame: 36 to 42 weeks gestation

    The 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.

  13. Wait Time

    Time frame: 36-42 weeks gestation

    Waited less than one hour for antenatal care (ANC) services (% yes)

  14. Prefer Group Antenatal Care (ANC) in the Future

    Time frame: 36-42 weeks gestation

    In late pregnancy, participants were asked if they would prefer individual or group antenatal care (ANC) if pregnant in the future (% preferring group ANC).

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • University of Malawi

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Sep 17, 2018
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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