Trial Outcomes & Findings for Group Antenatal Care and Delivery Project (NCT NCT04033003)

NCT ID: NCT04033003

Last Updated: 2024-06-07

Results Overview

Ability to identify danger signs in pregnancy will be measured utilizing a self-report, open ended, question that asks participants to identify warning signs that may occur during pregnancy (e.g. headache, vision changes, fever, vaginal bleeding, swollen face, etc.). There is no validated or standardized instrument to measure Birth Preparedness and Complication Readiness (BPCR). The measure used in this study is an open-end question: What are the danger signs during pregnancy? Things that might mean there is a problem with you or the baby. Fourteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 14. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1761 participants
• Primary outcome timeframe: T0 Baseline (at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
• Results posted on: 2024-06-07

Participant Flow

Fourteen health facilities were randomized using a matched-pair method. Variables for matching included the number of deliveries and the average gestational age of pregnancy at the time of enrollment, so that facilities within each pair are similar to each other. For each pair of facilities, one site was randomly assigned to group ANC (intervention) and the other to routine individual ANC (control). Individual women were recruited at each health facility.

Unit of analysis: Health Facilities

Participant milestones

Measure	Group ANC Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC Individual standard antenatal care delivered at health facilities in Ghana
T0 (Baseline at Recruitment) STARTED	877 7	884 7
T0 (Baseline at Recruitment) COMPLETED	877 7	884 7
T0 (Baseline at Recruitment) NOT COMPLETED	0 0	0 0
T1 (34 Wks Gestation - 3 Wks Postpartum) STARTED	877 7	884 7
T1 (34 Wks Gestation - 3 Wks Postpartum) COMPLETED	617 7	668 7
T1 (34 Wks Gestation - 3 Wks Postpartum) NOT COMPLETED	260 0	216 0
T2 (6 - 12 Weeks Postpartum) STARTED	730 7	858 7
T2 (6 - 12 Weeks Postpartum) COMPLETED	585 7	596 7
T2 (6 - 12 Weeks Postpartum) NOT COMPLETED	145 0	262 0
T3 (5 - 8 Month Postpartum) STARTED	718 7	843 7
T3 (5 - 8 Month Postpartum) COMPLETED	619 7	673 7
T3 (5 - 8 Month Postpartum) NOT COMPLETED	99 0	170 0
T4 (11 -14 Months Postpartum) STARTED	715 7	838 7
T4 (11 -14 Months Postpartum) COMPLETED	626 7	688 7
T4 (11 -14 Months Postpartum) NOT COMPLETED	89 0	150 0

Reasons for withdrawal

Measure	Group ANC Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC Individual standard antenatal care delivered at health facilities in Ghana
T1 (34 Wks Gestation - 3 Wks Postpartum) Lost to Follow-up	113	190
T1 (34 Wks Gestation - 3 Wks Postpartum) Protocol Violation	115	0
T1 (34 Wks Gestation - 3 Wks Postpartum) Withdrawal by Subject	2	6
T1 (34 Wks Gestation - 3 Wks Postpartum) No longer meets criteria	30	19
T1 (34 Wks Gestation - 3 Wks Postpartum) Death	0	1
T2 (6 - 12 Weeks Postpartum) Lost to Follow-up	133	247
T2 (6 - 12 Weeks Postpartum) Protocol Violation	4	0
T2 (6 - 12 Weeks Postpartum) Withdrawal by Subject	5	3
T2 (6 - 12 Weeks Postpartum) No longer meets criteria	1	10
T2 (6 - 12 Weeks Postpartum) Death	2	2
T3 (5 - 8 Month Postpartum) Lost to Follow-up	96	165
T3 (5 - 8 Month Postpartum) Withdrawal by Subject	3	5
T4 (11 -14 Months Postpartum) Lost to Follow-up	89	150

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group ANC n=877 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 Participants Individual standard antenatal care delivered at health facilities in Ghana	Total n=1761 Participants Total of all reporting groups
Age, Categorical <=18 years	29 Participants n=877 Participants	40 Participants n=884 Participants	69 Participants n=1761 Participants
Age, Categorical Between 18 and 65 years	848 Participants n=877 Participants	844 Participants n=884 Participants	1692 Participants n=1761 Participants
Age, Categorical >=65 years	0 Participants n=877 Participants	0 Participants n=884 Participants	0 Participants n=1761 Participants
Sex: Female, Male Female	877 Participants n=877 Participants	884 Participants n=884 Participants	1761 Participants n=1761 Participants
Sex: Female, Male Male	0 Participants n=877 Participants	0 Participants n=884 Participants	0 Participants n=1761 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Ghana	877 Participants n=877 Participants	884 Participants n=884 Participants	1761 Participants n=1761 Participants

PRIMARY outcome

Timeframe: T0 Baseline (at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)

Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668

Ability to identify danger signs in pregnancy will be measured utilizing a self-report, open ended, question that asks participants to identify warning signs that may occur during pregnancy (e.g. headache, vision changes, fever, vaginal bleeding, swollen face, etc.). There is no validated or standardized instrument to measure Birth Preparedness and Complication Readiness (BPCR).

The measure used in this study is an open-end question: What are the danger signs during pregnancy? Things that might mean there is a problem with you or the baby. Fourteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 14. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome.

Outcome measures

Measure	Group ANC n=877 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Ability to Identify Danger Signs in Pregnancy T0 - baseline	1.8 units on a scale Standard Deviation 1.3	1.7 units on a scale Standard Deviation 1.4
Change in Ability to Identify Danger Signs in Pregnancy T1 (34 weeks gestation - 3 weeks postdelivery)	3.4 units on a scale Standard Deviation 1.6	2.2 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)

Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668

Change in the ability to identify a strategy for birth preparedness and complication readiness (BPCR) will be measured using a binary response (yes/no) to a question that ask participants if they have: (1) saved money, (2) identified birth facility for delivery, (3) identified emergency transportation to the facility, and (4) identified a blood donor. There is no validated or standardized instrument to measure BPCR. The measure used in this study is an open-end question: What are some things a woman can do to prepare for birth? Eleven possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 11. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome.

Outcome measures

Measure	Group ANC n=877 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Birth Preparedness and Complication Readiness T0	1.4 units on a scale Standard Deviation 0.9	1.42 units on a scale Standard Deviation 0.9
Change in Birth Preparedness and Complication Readiness T1 (34 weeks gestation - 3 weeks postdelivery)	2.9 units on a scale Standard Deviation 1.5	1.7 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)

Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668

Ability to identify newborn danger signs will be measured utilizing a self-report, open ended, question that asks participants to identify newborn danger signs that may occur after delivery (e.g. poor suck, jaundice, difficulty/fast breathing, and convulsions). Change will be measured by calculating the difference in the mean at T0 and T1.

There is no validated or standardized instrument to measure Birth Preparedness and Complication Readiness (BPCR). The measure used in this study is an open-end question: What are the danger signs for your newborn? Things that might mean there is a problem. Thirteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 13. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome.

Outcome measures

Measure	Group ANC n=877 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Ability to Identify Newborn Danger Signs T0 Baseline at recruitment	1.9 units on a scale Standard Deviation 1.2	1.5 units on a scale Standard Deviation 1.2
Change in Ability to Identify Newborn Danger Signs T1 (34 weeks gestation - 3 weeks postdelivery)	1.8 units on a scale Standard Deviation 1.3	2.8 units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: T2 (6-12 weeks after delivery)

Attendance of 4 or more ANC visits will be gleaned from data reported on the participant's ANC/health card.

Outcome measures

Measure	Group ANC n=557 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=526 Participants Individual standard antenatal care delivered at health facilities in Ghana
Attendance of ANC Visits Yes	555 Participants	523 Participants
Attendance of ANC Visits No	2 Participants	3 Participants

PRIMARY outcome

Timeframe: T2 (6-12 weeks after delivery)

Place of delivery will be measured using a self-report question (facility delivery, home delivery).

Outcome measures

Measure	Group ANC n=585 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=593 Participants Individual standard antenatal care delivered at health facilities in Ghana
Place of Delivery Delivered at health facility	567 Participants	567 Participants
Place of Delivery Delivered at home	18 Participants	26 Participants

PRIMARY outcome

Timeframe: T2 (6-12 weeks after delivery)

Attendance of postpartum check-ups will be gleaned from information on the participant's ANC/health card.

Outcome measures

Measure	Group ANC n=584 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=591 Participants Individual standard antenatal care delivered at health facilities in Ghana
Attendance at Postpartum Check-ups for Mother Attended 2 day pp visit	392 Participants	451 Participants
Attendance at Postpartum Check-ups for Mother Attended 6 day pp visit	469 Participants	447 Participants
Attendance at Postpartum Check-ups for Mother Attended 6 week pp visit	517 Participants	541 Participants

PRIMARY outcome

Timeframe: T2 (6-12 weeks after delivery)

Attendance of postnatal checkup will be gleaned from information on the participant's ANC/health card using a measure of 3 visits before 6 weeks for newborns.

Outcome measures

Measure	Group ANC n=580 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=585 Participants Individual standard antenatal care delivered at health facilities in Ghana
Attendance at Postnatal Check-up for Newborn 6 day postnatal visit	473 Participants	453 Participants
Attendance at Postnatal Check-up for Newborn 2 day postnatal visit	412 Participants	460 Participants
Attendance at Postnatal Check-up for Newborn 6 week postnatal visit	531 Participants	550 Participants

PRIMARY outcome

Timeframe: T2 (6-12 weeks after delivery)

Birth outcomes will be self-reported and measured as stillbirth, live birth, early neonatal mortality.

Outcome measures

Measure	Group ANC n=585 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=595 Participants Individual standard antenatal care delivered at health facilities in Ghana
Birth Outcome Live birth	580 Participants	587 Participants
Birth Outcome Stillbirth	5 Participants	8 Participants
Birth Outcome Early neonatal mortality	6 Participants	7 Participants

PRIMARY outcome

Timeframe: T0 (Baseline at recruitment) and T2 (6 - 12 weeks postdelivery)

Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T2 = 585 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T2 = 596

Change in Health Literacy will be measured using the Maternal Health Literacy Scale. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 to T2.

Maternal Health Literacy (MaHeLi) scale is a validated measure that consists of 12 yes-or-no questions to assess maternal health literacy among the participants. Raw item scores are a sum of individual responses; scores range from 0 to 12. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome.

Outcome measures

Measure	Group ANC n=887 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Health Literacy T0 - baseline	9.6 score on a scale Standard Deviation 1.7	9.7 score on a scale Standard Deviation 1.6
Change in Health Literacy T2 - 6 weeks post-delivery	11.3 score on a scale Standard Deviation 0.9	11 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)

Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668

Ability to identify danger signs after delivery will be measured utilizing a self-report, open ended, question that asks participants to identify warning signs that may occur after delivery (e.g. increased bleeding or large clots; weakness/fainting; fever; pain in abdominal or breast; painful urination, etc.). Change will be measured by calculating the difference in the mean at T0 (baseline) and T1 (34 weeks gestation - 3 weeks postdelivery).

There is no validated or standardized instrument to measure postpartum danger signs. The measure used in this study is an open-end question: What are the danger signs for you, the mother, after the baby is born? Fourteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 14. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome.

Outcome measures

Measure	Group ANC n=877 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Ability to Identify Postpartum Danger Signs for Mother T0	1.26 units on a scale Standard Deviation 1.1	1.17 units on a scale Standard Deviation 1.1
Change in Ability to Identify Postpartum Danger Signs for Mother T1	2.44 units on a scale Standard Deviation 1.3	1.69 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)

Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668

Ability of mother to identify recommended action steps in response to danger signs that may occur before or after delivery. There is no validated or standardized instrument to measure this outcome, therefore the measure used in this study is the question: What do you think you would do if you have any of these (danger signs)? Responses are coded as Go to hospital or health facility CHECKED (1) or Go to hospital or health facility NOT CHECKED (0). Reported results are the sum of individual responses; higher score "Go to hospital checked" means a better outcome.

Outcome measures

Measure	Group ANC n=877 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Ability to Identify the Recommended Action Steps When a Problem is Identified T1 · Go to hospital or health facility NOT CHECKED	23 Participants	116 Participants
Change in Ability to Identify the Recommended Action Steps When a Problem is Identified T0 · Go to hospital or health facility CHECKED	671 Participants	636 Participants
Change in Ability to Identify the Recommended Action Steps When a Problem is Identified T0 · Go to hospital or health facility NOT CHECKED	206 Participants	248 Participants
Change in Ability to Identify the Recommended Action Steps When a Problem is Identified T1 · Go to hospital or health facility CHECKED	594 Participants	552 Participants

SECONDARY outcome

Timeframe: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)

Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668

Knowledge of family planning methods will be measured by self-report using a question that asks participants to identify all the methods of family planning they know. Change will be measured by calculating the difference in the mean at baseline and 3rd trimester.

There is no validated or standardized instrument to measure this outcome, therefore the measure used in this study is an open-end question that asks participants to identify all the methods of family planning they know. Change will be measured by calculating the difference in the mean at T0 (baseline) and T1 (34 weeks gestation - 3 weeks postdelivery). There are eleven possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 11. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome.

Outcome measures

Measure	Group ANC n=877 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Knowledge of Family Planning Methods T0	2.22 units on a scale Standard Deviation 1.3	2.01 units on a scale Standard Deviation 1.39
Change in Knowledge of Family Planning Methods T1	3.88 units on a scale Standard Deviation 1.7	2.37 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)

Population: Group ANC: Number of participants analyzed at T0 = 747; Number of participants analyzed at T1 = 526 Standard ANC: Number of participants analyzed at T0 = 760; Number of participants analyzed at T1 = 525

Intent to use family planning methods will be measured by self-report using a binary (yes/no) question that asks participants, "Do you intend to use family planning after delivery?". Responses are coded as yes = 1 or no = 0. A higher number equals those who indicated yes to their intent to use family planning after delivery. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 (baseline) to T1( 34 weeks gestation - 3 weeks postdelivery).

Outcome measures

Measure	Group ANC n=747 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=760 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Intent to Use Family Planning T0	0.38 units on a scale Standard Deviation 0.5	0.41 units on a scale Standard Deviation 0.5
Change in Intent to Use Family Planning T1	0.61 units on a scale Standard Deviation 0.5	0.42 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum)

Population: Group ANC: Number of participants analyzed at T2 = 585; Number analyzed at T3 = 619; Number analyzed at T4 = 609 Standard ANC: Number of participants analyzed at T0 592= ; Number analyzed at T1 = 673; Number analyzed at T4 = 674 Participants lost to follow-up at T2 and T3 remain eligible to complete surveys at subsequent timepoints. Thus, there may be more participants analyzed at later timepoints.

Uptake of family planning will be measured by self-report using a binary (yes/no) question that asks participants if they are currently using any family planning method. Responses are coded as yes = 1 or no = 0. A higher number equals those who indicated "yes" to currently using family planning. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum).

Outcome measures

Measure	Group ANC n=619 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=674 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Uptake of Family Planning T2	0.15 units on a scale Standard Deviation 0.4	0.09 units on a scale Standard Deviation 0.3
Change in Uptake of Family Planning T3	0.25 units on a scale Standard Deviation 0.4	0.2 units on a scale Standard Deviation 0.4
Change in Uptake of Family Planning T4	0.35 units on a scale Standard Deviation 0.5	0.43 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: T0 (baseline) and T4 (11 - 14 months postpartum)

Population: Group ANC: Number of participants analyzed at T0 = 873 ; Number of participants analyzed at T4 = 626 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T4 = 686

Experiences of physical, sexual, and emotional violence were measured using an investigator-derived questionnaire that asks participants if they experienced violence in the past year, and if resources and support are available to them. Raw item scores are a sum of individual responses; scores range from 0 to 9. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T4. Higher score means higher rates of reported sexual and emotional violence and lower access to resources and support.

Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 (baseline) to T4 (11 - 14 months postpartum)

Outcome measures

Measure	Group ANC n=873 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 Participants Individual standard antenatal care delivered at health facilities in Ghana
Change in Interpersonal Violence T0	4.48 units on a scale Standard Deviation 1.4	4.59 units on a scale Standard Deviation 1.4
Change in Interpersonal Violence T4	4.62 units on a scale Standard Deviation 1.0	4.78 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: T2 (6-12 postpartum)

Experience of ANC care is measured using a twenty-one item investigator-derived questionnaire that asks participants about their experience regarding respectful care, satisfaction with care, and experience such as privacy and treatment with health system during their ANC visits. Raw item scores are a sum of individual responses; scores range from 0 to 21. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome.

Outcome measures

Measure	Group ANC n=585 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=592 Participants Individual standard antenatal care delivered at health facilities in Ghana
Experience of ANC Care	20.1 units on a scale Standard Deviation 1.4	18.79 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: T1 (34 weeks gestation - 3 weeks postdelivery)

Data gleaned from the participant's ANC/health record will be used to measure affirmative completion of IPTp2 malaria prophylaxis during pregnancy.

Outcome measures

Measure	Group ANC n=612 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=657 Participants Individual standard antenatal care delivered at health facilities in Ghana
Completion of IPTp2 Malaria Prophylaxis During Pregnancy YES (completed IPTp2 malaria prophylaxis during pregnancy)	375 Participants	419 Participants
Completion of IPTp2 Malaria Prophylaxis During Pregnancy NO (did not complete IPTp2 malaria prophylaxis during pregnancy)	237 Participants	238 Participants

SECONDARY outcome

Timeframe: T1 (34 weeks gestation - 3 weeks postdelivery)

Data gleaned from the participant's ANC/health record will be used to measure if the participant received least two tetanus toxoid vaccines during pregnancy.

Outcome measures

Measure	Group ANC n=611 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=660 Participants Individual standard antenatal care delivered at health facilities in Ghana
Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy YES (received at least two tetanus toxoid vaccines during pregnancy)	487 Participants	518 Participants
Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy No (did not receive at least two tetanus toxoid vaccines during pregnancy)	124 Participants	142 Participants

SECONDARY outcome

Timeframe: T2 (6-12 weeks postpartum)

Newborn weight in grams; these data will be retrieved from the participant's ANC/health card and measured as newborn weight.

Outcome measures

Measure	Group ANC n=492 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=469 Participants Individual standard antenatal care delivered at health facilities in Ghana
Newborn Weight ≥ 2500 g	459 Participants	431 Participants
Newborn Weight < 2500 g	33 Participants	38 Participants

SECONDARY outcome

Timeframe: T2 (6 - 12 weeks postpartum)

Mother's hemoglobin at delivery; these data will be retrieved from the participant's ANC/health card and measured as hemoglobin in grams per deciliter (g/dl).

Outcome measures

Measure	Group ANC n=491 Participants Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=493 Participants Individual standard antenatal care delivered at health facilities in Ghana
Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). Severely anemic (< 7.5)	4 Participants	3 Participants
Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). Moderately anemic (> 7.5, <11)	176 Participants	177 Participants
Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). Normal (>11)	311 Participants	313 Participants

Adverse Events

Group ANC

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Stand ANC

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Group ANC n=877 participants at risk Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.	Stand ANC n=884 participants at risk Individual standard antenatal care delivered at health facilities in Ghana
Pregnancy, puerperium and perinatal conditions Death not related to study protocol	0.23% 2/877 • Number of events 2 • from time of enrollment until study completion (11-14 months post delivery) clinicaltrials.gov definition	0.34% 3/884 • Number of events 3 • from time of enrollment until study completion (11-14 months post delivery) clinicaltrials.gov definition

Other adverse events

Adverse event data not reported

Additional Information

Jody R. Lori PhD, Associate Dean for Global Affairs, Director, PAHO/WHO Collaborating Center

University of Michigan, School of Nursing

Phone: 734-763-0097

Email: jrlori@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place