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.
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.
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.
Bangwe HC
Blantyre, Malawi
Chileka HC
Blantyre, Malawi
Chilomoni HC
Blantyre, Malawi
Limbe HC
Blantyre, Malawi
Lirangwe HC
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.
Time frame: 8 weeks postpartum
Partner HIV Test
Proportion of partners tested during this pregnancy
Time frame: 36-42 weeks gestation
Spontaneous Abortion
Pregnancy loss less than 20 weeks
Time frame: 36-42 weeks gestation
Stillbirth
Baby born with no signs of life at or after 28 weeks gestational age
Time frame: 8 weeks postpartum
Infant Death
Infant death before the end of the study
Time frame: 6 months postpartum
Maternal Death
Maternal death before the end of the study
Time frame: 6 months postpartum
Anemia
Hemoglobin level of \<11 g/dl
Time frame: 36-42 weeks gestation
Family Planning
Reported use of family planning at late postpartum, approximately 6 months after delivery
Time frame: 6 months postpartum
Exclusive Breastfeeding
Exclusive breastfeeding for six months (yes)
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
1,887
Blantyre, Malawi
Madziabango HC
Blantyre, Malawi
Ndirande HC
Blantyre, Malawi
Time frame: 6 months postpartum
Self Reporting Questionnaire (SRQ)
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.
Time frame: 8 weeks postpartum
Satisfaction With Antenatal Care (ANC)
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.
Time frame: 36-42 weeks gestation
Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct
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).
Time frame: 36-42 weeks gestation
Mean Antenatal Care (ANC) Contacts
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
Time frame: 8 weeks postpartum
Pregnancy-related Empowerment Scale (PRES)
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.
Time frame: 36 to 42 weeks gestation
Wait Time
Waited less than one hour for antenatal care (ANC) services (% yes)
Time frame: 36-42 weeks gestation
Prefer Group Antenatal Care (ANC) in the Future
In late pregnancy, participants were asked if they would prefer individual or group antenatal care (ANC) if pregnant in the future (% preferring group ANC).
Time frame: 36-42 weeks gestation