Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
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ClinicalTrials.gov Identifier: NCT03673709 |
Recruitment Status :
Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : April 13, 2023
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Condition or disease | Intervention/treatment | Phase |
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Premature Birth | Behavioral: Antenatal Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1776 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
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. |
Primary Purpose: | Health Services Research |
Official Title: | Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi |
Actual Study Start Date : | July 5, 2019 |
Estimated Primary Completion Date : | July 15, 2023 |
Estimated Study Completion Date : | May 31, 2024 |
Arm | Intervention/treatment |
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No Intervention: Individual Antenatal Care (usual care)
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.
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Experimental: Group Antenatal Care (intervention)
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.
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Behavioral: Antenatal 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. |
- Preterm birth [ Time Frame: 8 weeks postpartum ]Newborn born before 37 weeks gestational age
- Partner HIV Test [ Time Frame: Enrollment, 36-42 weeks gestation ]Proportion of partners tested during this pregnancy
- Spontaneous abortion [ Time Frame: 36-42 weeks gestation ]Pregnancy loss less than 20 weeks
- Stillbirth [ Time Frame: 8 weeks postpartum ]Baby born with no signs of life at or after 28 weeks gestational age
- Low birthweight [ Time Frame: 8 weeks postpartum ]Newborn weighing less than 2.5 kg or 2500 grams, measured within 24 hours of birth
- Neonatal death [ Time Frame: 8 weeks postpartum ]Newborn dies between 0-28 days after birth
- Maternal death [ Time Frame: 8 weeks postpartum, 6 months postpartum ]Woman dies in pregnancy or within 42 days of the end of pregnancy
- Woman HIV test [ Time Frame: Enrollment, 36-42 weeks gestation ]Initial HIV test, if seronegative then repeated in 3rd trimester of pregnancy
- Anemia [ Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum ]Hemoglobin
- Postpartum bleeding [ Time Frame: 8 weeks postpartum ]Blood loss of greater than 500 ml (yes/no) or greater than 1000 ml (yes/no)
- Hypertension [ Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum ]Blood pressure
- Family planning [ Time Frame: 8 weeks postpartum; 6 months postpartum ]Using a family planning method (yes/no)
- Exclusive breastfeeding [ Time Frame: 8 weeks postpartum; 6 months postpartum ]Duration in days
- Early repeat pregnancy [ Time Frame: 8 weeks postpartum; 6 months postpartum ]Negative pregnancy test and no reported pregnancy loss
- ART medication (woman) [ Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum ]Received medication from intake through six months postpartum
- HIV test infant [ Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum ]Infant tested for HIV and results received
- Self Reporting Questionnaire (SRQ) [ Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum ]The Self Reporting Questionnaire (SRQ) is a brief measure of psychiatric symptomatology designed by the WHO to be used to screen for common mental disorders. It consists of 20 questions with yes/no answers exploring symptoms of depression, anxiety, and somatic complaints such as headache and non-specific gastrointestinal symptoms. SRQ has been translated and validated in several African countries. A recent study conducted in Rwanda reported the α = 0.85 for refugee women. It consists of 20 Yes/No Items, with a total score range from 0-20; α = 0.789. Higher scores indicate more distress.
- Satisfaction with care [ Time Frame: 36-42 weeks gestation ]10-item satisfaction with antenatal care index; 5 point Likert scale [1 (poor) and to 5 (excellent)], range 10-50, α =0.980
- Healthcare utilization [ Time Frame: 36-42 weeks gestation; 8 weeks postpartum ]Pre- and postnatal care attendance; health facility birth (yes/no), services received (21 items); content covered (18 items)
- Adequate HIV knowledge [ Time Frame: Enrollment, 36-42 weeks gestation ]Total HIV Knowledge is the number of questions answered correctly for five HIV-prevention items defined by UNAIDS as essential plus an additional four items from the Malawi Demographic and Health Survey assessing prevention of maternal-to-child transmission. Higher scores indicate more knowledge about how HIV is transmitted.

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673709
Malawi | |
Bangwe HC | |
Blantyre, Malawi | |
Chileka HC | |
Blantyre, Malawi | |
Chilomoni HC | |
Blantyre, Malawi | |
Limbe HC | |
Blantyre, Malawi | |
Lirangwe HC | |
Blantyre, Malawi | |
Madziabango HC | |
Blantyre, Malawi |
Principal Investigator: | Crystal L Patil, PhD | University of Illinois at Chicago |
Responsible Party: | Crystal L. Patil, PhD, Associate Professor, University of Illinois at Chicago |
ClinicalTrials.gov Identifier: | NCT03673709 |
Other Study ID Numbers: |
2018-0845 R01NR018115 ( U.S. NIH Grant/Contract ) |
First Posted: | September 17, 2018 Key Record Dates |
Last Update Posted: | April 13, 2023 |
Last Verified: | April 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications |
Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |