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

NCT03673709 — Not applicable, Completed, 1887 participants, University of Illinois at Chicago

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

RegistryNCT03673709
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, health services research
Enrollment1887 (Actual)
SponsorUniversity of Illinois at Chicago (Other); collaborators: University of Malawi, National Institute of Nursing Research (NINR)
ConditionsPremature Birth
InterventionsAntenatal Care (Behavioral)
Datesstart 2019-07-05, primary completion 2023-08-10, completion 2024-05-31, first posted 2018-09-17, last updated 2026-07-13
Locations7 sites in Malawi

Related Papers Related Patents Related Grants Related Experts
All trials for Premature Birth All trials of Antenatal Care

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
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)ExperimentalBehavioral: Antenatal CareWomen 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.
  • 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.

+Outcome measures

Primary outcomes

  • Born Weighing Less Than 2500 g [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.
  • Partner HIV Test [36-42 weeks gestation]: Proportion of partners tested during this pregnancy

Secondary outcomes

  • Spontaneous Abortion [36-42 weeks gestation]: Pregnancy loss less than 20 weeks
  • Stillbirth [8 weeks postpartum]: Baby born with no signs of life at or after 28 weeks gestational age
  • Infant Death [6 months postpartum]: Infant death before the end of the study
  • Maternal Death [6 months postpartum]: Maternal death before the end of the study
  • Anemia [36-42 weeks gestation]: Hemoglobin level of <11 g/dl
  • Family Planning [6 months postpartum]: Reported use of family planning at late postpartum, approximately 6 months after delivery
  • Exclusive Breastfeeding [6 months postpartum]: Exclusive breastfeeding for six months (yes)
  • Self Reporting Questionnaire (SRQ) [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.
  • Satisfaction With Antenatal Care (ANC) [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.
  • Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct [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).
  • Mean Antenatal Care (ANC) Contacts [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
  • Pregnancy-related Empowerment Scale (PRES) [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.
  • Wait Time [36-42 weeks gestation]: Waited less than one hour for antenatal care (ANC) services (% yes)
  • Prefer Group Antenatal Care (ANC) in the Future [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).

+Eligibility

Sex: Female, ages: 15 Years to any, accepts healthy volunteers

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)

+Posted results

Participant flow

MilestoneIndividual Antenatal CareGroup Antenatal Care
Started941946
Late pregnancy683723
Early postpartum811845
Completed747767
Not completed194179

Outcome results

  • Born Weighing Less Than 2500 g (Primary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 73; Group Antenatal Care (Intervention) 87
  • Partner HIV Test (Primary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 594; Group Antenatal Care (Intervention) 644
  • Spontaneous Abortion (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 17; Group Antenatal Care (Intervention) 10
  • Stillbirth (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 8; Group Antenatal Care (Intervention) 13
  • Infant Death (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 16; Group Antenatal Care (Intervention) 22
  • Maternal Death (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 0; Group Antenatal Care (Intervention) 1
  • Anemia (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 318; Group Antenatal Care (Intervention) 315
  • Family Planning (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 703; Group Antenatal Care (Intervention) 726
  • Exclusive Breastfeeding (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 454; Group Antenatal Care (Intervention) 491
  • Self Reporting Questionnaire (SRQ) (Secondary), Mean, score on a scale: Individual Antenatal Care (Usual Care) 7.57 +/- 4.89; Group Antenatal Care (Intervention) 7.16 +/- 4.91
  • Satisfaction With Antenatal Care (ANC) (Secondary), Mean, units on a scale: Individual Antenatal Care (Usual Care) 32.8 +/- 7.95; Group Antenatal Care (Intervention) 34.9 +/- 8.0
  • Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 351; Group Antenatal Care (Intervention) 475
  • Mean Antenatal Care (ANC) Contacts (Secondary), Mean, Contacts: Individual Antenatal Care (Usual Care) 4.8 +/- 1.91; Group Antenatal Care (Intervention) 5.6 +/- 2.0
  • Pregnancy-related Empowerment Scale (PRES) (Secondary), Mean, score on a scale: Individual Antenatal Care (Usual Care) 56.48 +/- 7.13; Group Antenatal Care (Intervention) 56.65 +/- 6.25
  • Wait Time (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 453; Group Antenatal Care (Intervention) 625
  • Prefer Group Antenatal Care (ANC) in the Future (Secondary), Count of participants, Participants: Individual Antenatal Care (Usual Care) 553; Group Antenatal Care (Intervention) 690

Adverse events

Time frame: The specific time period was 1 year, from baseline (in mid-pregnancy) until the end of follow-up at 6 months postpartum.

ArmDeathsSerious adverse eventsOther adverse events
Individual Antenatal Care Women0/941 (0.0%)0/941 (0.0%)0/941 (0.0%)
Individual Antenatal Care Infants16/815 (2.0%)0/815 (0.0%)0/815 (0.0%)
Group Antenatal Care Women1/946 (0.1%)0/946 (0.0%)0/946 (0.0%)
Group Antenatal Care Infants22/848 (2.6%)0/848 (0.0%)0/848 (0.0%)

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

+Locations (7)

FacilityCityCountryStatus
Bangwe HCBlantyreMalawi
Chileka HCBlantyreMalawi
Chilomoni HCBlantyreMalawi
Limbe HCBlantyreMalawi
Lirangwe HCBlantyreMalawi
Madziabango HCBlantyreMalawi
Ndirande HCBlantyreMalawi

+Publications

  • Results publication: 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 40531963
  • Results publication: 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 33098114
  • Results publication: 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 32039721

+Study documents

+Investigators

+Funding

NIH grants: R01NR018115