Trial Outcomes & Findings for Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi (NCT NCT03673709)
NCT ID: NCT03673709
Last Updated: 2026-07-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1887 participants
Primary outcome timeframe
8 weeks postpartum
Results posted on
2026-07-13
Participant Flow
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
Participant milestones
| Measure |
Individual Antenatal 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.
|
Group Antenatal Care
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
941
|
946
|
|
Overall Study
Late Pregnancy
|
683
|
723
|
|
Overall Study
Early Postpartum
|
811
|
845
|
|
Overall Study
COMPLETED
|
747
|
767
|
|
Overall Study
NOT COMPLETED
|
194
|
179
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
Baseline characteristics by cohort
| Measure |
Individual Antenatal Care (Usual Care)
n=941 Participants
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.
|
Group Antenatal Care (Intervention)
n=946 Participants
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.
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.
|
Total
n=1887 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
15-19 years
|
261 Participants
n=20 Participants
|
235 Participants
n=20 Participants
|
496 Participants
n=40 Participants
|
|
Age, Customized
20-29 years
|
545 Participants
n=20 Participants
|
570 Participants
n=20 Participants
|
1115 Participants
n=40 Participants
|
|
Age, Customized
30-35 years
|
135 Participants
n=20 Participants
|
141 Participants
n=20 Participants
|
276 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
941 Participants
n=20 Participants
|
946 Participants
n=20 Participants
|
1887 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
941 Participants
n=20 Participants
|
946 Participants
n=20 Participants
|
1887 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
Malawi
|
941 participants
n=20 Participants
|
946 participants
n=20 Participants
|
1887 participants
n=40 Participants
|
|
Education category
Less than primary
|
422 Participants
n=20 Participants
|
414 Participants
n=20 Participants
|
836 Participants
n=40 Participants
|
|
Education category
Completed primary
|
386 Participants
n=20 Participants
|
381 Participants
n=20 Participants
|
767 Participants
n=40 Participants
|
|
Education category
More than primary
|
133 Participants
n=20 Participants
|
151 Participants
n=20 Participants
|
284 Participants
n=40 Participants
|
|
Ownership Index (0-3)
0 items owned
|
191 Participants
n=20 Participants
|
179 Participants
n=20 Participants
|
370 Participants
n=40 Participants
|
|
Ownership Index (0-3)
1 item owned
|
454 Participants
n=20 Participants
|
454 Participants
n=20 Participants
|
908 Participants
n=40 Participants
|
|
Ownership Index (0-3)
2 items owned
|
254 Participants
n=20 Participants
|
271 Participants
n=20 Participants
|
525 Participants
n=40 Participants
|
|
Ownership Index (0-3)
3 items owned
|
42 Participants
n=20 Participants
|
41 Participants
n=20 Participants
|
83 Participants
n=40 Participants
|
|
Ownership Index (0-3)
Missing
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Experienced Food Insecurity in last 12 months
Yes, Did Experience Food Insecurity in last 12 months
|
649 Participants
n=20 Participants
|
645 Participants
n=20 Participants
|
1294 Participants
n=40 Participants
|
|
Experienced Food Insecurity in last 12 months
No, Did Not Experience Food Insecurity in last 12 months
|
292 Participants
n=20 Participants
|
301 Participants
n=20 Participants
|
593 Participants
n=40 Participants
|
|
In a relationship (married, living with a partner, or dating)
In a relationship (married, living with a partner, or dating)
|
874 Participants
n=20 Participants
|
886 Participants
n=20 Participants
|
1760 Participants
n=40 Participants
|
|
In a relationship (married, living with a partner, or dating)
Not In a relationship (married, living with a partner, or dating)
|
67 Participants
n=20 Participants
|
60 Participants
n=20 Participants
|
127 Participants
n=40 Participants
|
|
Pregnant for the first time (\primiparous)
|
395 Participants
n=20 Participants
|
379 Participants
n=20 Participants
|
774 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 8 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.
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=766 Participants
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.
|
Group Antenatal Care (Intervention)
n=792 Participants
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.
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.
|
|---|---|---|
|
Born Weighing Less Than 2500 g
Yes, less than 2500 grams
|
73 Participants
|
87 Participants
|
|
Born Weighing Less Than 2500 g
No, not less than 2500 grams
|
693 Participants
|
705 Participants
|
PRIMARY outcome
Timeframe: 36-42 weeks gestationPopulation: The number does not reflect the total in Participant Flow due to missing data and exclusion of participants who identified as HIV positive, so would not need to be tested for HIV
Proportion of partners tested during this pregnancy
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=791 Participants
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.
|
Group Antenatal Care (Intervention)
n=816 Participants
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.
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.
|
|---|---|---|
|
Partner HIV Test
|
594 Participants
|
644 Participants
|
SECONDARY outcome
Timeframe: 36-42 weeks gestationPregnancy loss less than 20 weeks
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=815 Participants
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.
|
Group Antenatal Care (Intervention)
n=848 Participants
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.
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.
|
|---|---|---|
|
Spontaneous Abortion
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 8 weeks postpartumBaby born with no signs of life at or after 28 weeks gestational age
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=815 Participants
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.
|
Group Antenatal Care (Intervention)
n=848 Participants
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.
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.
|
|---|---|---|
|
Stillbirth
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumInfant death before the end of the study
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=815 Participants
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.
|
Group Antenatal Care (Intervention)
n=848 Participants
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.
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.
|
|---|---|---|
|
Infant Death
|
16 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumMaternal death before the end of the study
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=941 Participants
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.
|
Group Antenatal Care (Intervention)
n=946 Participants
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.
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.
|
|---|---|---|
|
Maternal Death
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 36-42 weeks gestationHemoglobin level of \<11 g/dl
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=680 Participants
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.
|
Group Antenatal Care (Intervention)
n=719 Participants
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.
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.
|
|---|---|---|
|
Anemia
|
318 Participants
|
315 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumReported use of family planning at late postpartum, approximately 6 months after delivery
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=747 Participants
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.
|
Group Antenatal Care (Intervention)
n=768 Participants
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.
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.
|
|---|---|---|
|
Family Planning
|
703 Participants
|
726 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumExclusive breastfeeding for six months (yes)
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=722 Participants
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.
|
Group Antenatal Care (Intervention)
n=749 Participants
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.
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.
|
|---|---|---|
|
Exclusive Breastfeeding
|
454 Participants
|
491 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=617 Participants
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.
|
Group Antenatal Care (Intervention)
n=655 Participants
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.
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.
|
|---|---|---|
|
Self Reporting Questionnaire (SRQ)
|
7.57 score on a scale
Standard Deviation 4.89
|
7.16 score on a scale
Standard Deviation 4.91
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=683 Participants
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.
|
Group Antenatal Care (Intervention)
n=723 Participants
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.
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.
|
|---|---|---|
|
Satisfaction With Antenatal Care (ANC)
|
32.8 units on a scale
Standard Deviation 7.95
|
34.9 units on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: 36-42 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).
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=883 Participants
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.
|
Group Antenatal Care (Intervention)
n=723 Participants
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.
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.
|
|---|---|---|
|
Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct
|
351 Participants
|
475 Participants
|
SECONDARY outcome
Timeframe: 8 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
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=941 Participants
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.
|
Group Antenatal Care (Intervention)
n=946 Participants
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.
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.
|
|---|---|---|
|
Mean Antenatal Care (ANC) Contacts
|
4.8 Contacts
Standard Deviation 1.91
|
5.6 Contacts
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=683 Participants
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.
|
Group Antenatal Care (Intervention)
n=724 Participants
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.
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.
|
|---|---|---|
|
Pregnancy-related Empowerment Scale (PRES)
|
56.48 score on a scale
Standard Deviation 7.13
|
56.65 score on a scale
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: 36-42 weeks gestationWaited less than one hour for antenatal care (ANC) services (% yes)
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=683 Participants
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.
|
Group Antenatal Care (Intervention)
n=723 Participants
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.
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.
|
|---|---|---|
|
Wait Time
|
453 Participants
|
625 Participants
|
SECONDARY outcome
Timeframe: 36-42 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).
Outcome measures
| Measure |
Individual Antenatal Care (Usual Care)
n=683 Participants
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.
|
Group Antenatal Care (Intervention)
n=724 Participants
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.
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.
|
|---|---|---|
|
Prefer Group Antenatal Care (ANC) in the Future
|
553 Participants
|
690 Participants
|
Adverse Events
Individual Antenatal Care Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Antenatal Care Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 16 deaths
Group Antenatal Care Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Group Antenatal Care Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 22 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place