Group Antenatal Care and Delivery Project

NCT04033003 | Completed Results

• 2 other identifiers: HUM00161464R01HD096277
• Study Type: interventional
• Target: 1,761
• Locations: 1 country
• Sites: 14

Brief Summary

Antenatal care (ANC) has the potential to play a pivotal role in ensuring positive pregnancy outcomes for both mothers and their newborns. A critical component of all ANC is teaching women to recognize the major complications that account for the majority of preventable maternal and newborn deaths. Antenatal care provides an opportunity to promote a healthy lifestyle, to integrate positive health behaviors, and to develop a trusting relationship with a provider and the health system. While group ANC has been delivered and studied in high-resource settings for over a decade, it has only recently been introduced as an alternative to individual care in sub-Saharan Africa. The goal of this research is to improve health literacy and reduce preventable maternal and newborn morbidities and mortality within highly vulnerable, low and non-literate populations that assume a disproportionate burden of poor pregnancy outcomes globally. This research examines a bold, new approach to ANC that takes provision of care out of clinic exam rooms into small groups of women grouped by gestational age in low resource settings with low and non-literate populations. Group ANC has the potential to shift the current clinical practice paradigm of antenatal care for highly vulnerable women to improve maternal and newborn outcomes both globally and domestically. The investigators hypothesize that pregnant women randomized into group ANC will exhibit increased health literacy through: 1) increased birth preparedness and complication readiness (BPCR), including recognition of danger signs and knowledge of how to respond to such signs; 2) higher rates of care-seeking behaviors, including seeking care for problems identified during pregnancy, higher facility delivery rates, and increased attendance at postnatal and postpartum care; and 3) better clinical outcomes for themselves and their newborns than women who received the routine, individual ANC.

Conditions

Antenatal Care

Keywords

Antenatal care; Sub-Saharan Africa; Ghana

Outcome Measures

Primary Outcomes (9)

• Change in Ability to Identify Danger Signs in Pregnancy

  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.

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

• Change in Birth Preparedness and Complication Readiness

  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.

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

• Change in Ability to Identify Newborn Danger Signs

  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.

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

• Attendance of ANC Visits

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

  T2 (6-12 weeks after delivery)

• Place of Delivery

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

  T2 (6-12 weeks after delivery)

• Attendance at Postpartum Check-ups for Mother

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

  T2 (6-12 weeks after delivery)

• Attendance at Postnatal Check-up for Newborn

  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.

  T2 (6-12 weeks after delivery)

• Birth Outcome

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

  T2 (6-12 weeks after delivery)

• Change in Health Literacy

  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.

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

Secondary Outcomes (11)

• Change in Ability to Identify Postpartum Danger Signs for Mother

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

• Change in Ability to Identify the Recommended Action Steps When a Problem is Identified

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

• Change in Knowledge of Family Planning Methods

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

• Change in Intent to Use Family Planning

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

• Change in Uptake of Family Planning

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

Study Arms (2)

Group ANC

EXPERIMENTAL

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.

Behavioral: Group ANC

Stand ANC

NO INTERVENTION

Individual standard antenatal care delivered at health facilities in Ghana

Interventions

Group ANC BEHAVIORAL

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.

Group ANC

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Study for pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• willingness to participate in the study
• less than 20 weeks' gestation 3) able to speak Dangme, Ga, Akan, Ewe, or English
• over the age of 15 years

You may not qualify if:

• No history of medical problems that would indicate the participant might be considered "high risk" (e.g., hypertension, insulin-dependent diabetes mellitus) and thus requiring a more individualized approach to care.

Sponsors & Collaborators

• University of Michigan: lead
• Dodowa Health Research Centre: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (14)

Adawso Health Center

Adawso, Ghana

Location

Adukrom Health Center

Adukrom, Ghana

Location

Klo Agogo Polyclinic

Agogo, Ghana

Location

Abiriw Clinic

Akropong, Ghana

Location

St Martin's Hospital

Akropong, Ghana

Location

Akuse Hospital

Akuse, Ghana

Location

Nkurakan Health Center

Koforidua, Ghana

Location

Tetteh Quarshie Hospital

Mampong, Ghana

Location

Adoagyiri Health Center

Nsawam, Ghana

Location

Djankrom Health Center

Nsawam, Ghana

Location

Nsawam Health Center

Nsawam, Ghana

Location

Nsawam Hospital

Nsawam, Ghana

Location

Atua Hospital

Somanya, Ghana

Location

Somanya Polyclinic

Somanya, Ghana

Location

Related Publications (4)

• Lanyo TN, Williams JEO, Ghosh B, Apetorgbor VEA, Kukula VA, Zielinski R, Awini E, Moyer CA, Lori J. Impact of group antenatal care on lactational amenorrhea method awareness and knowledge: A cluster randomized control trial. PLoS One. 2025 Oct 15;20(10):e0333074. doi: 10.1371/journal.pone.0333074. eCollection 2025.

  PMID: 41091707 DERIVED

• Apetorgbor V, Awini E, Ghosh B, Zielinski R, Amankwah G, Kukula VA, James K, Williams JEO, Lori JR, Moyer CA. The impact of group antenatal care on newborns: Results of a cluster randomized control trial in Eastern Region, Ghana. BMC Pediatr. 2024 Nov 18;24(1):747. doi: 10.1186/s12887-024-05225-9.

  PMID: 39558280 DERIVED

• Kukula VA, Awini E, Ghosh B, Apetorgbor V, Zielinski R, Amankwah G, Ofosu WK, James K, Williams JEO, Lori JR, Moyer CA. Effect of group antenatal care versus individualized antenatal care on birth preparedness and complication readiness: a cluster randomized controlled study among pregnant women in Eastern Region of Ghana. BMC Pregnancy Childbirth. 2024 Aug 16;24(1):546. doi: 10.1186/s12884-024-06743-1.

  PMID: 39152408 DERIVED

• Lori JR, Williams JEO, Kukula VA, Apetorgbor VEA, Awini EA, Amankwah G, Zielinski R, Lockhart N, James KH, Moyer CA. Group Antenatal Care in Ghana: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 9;11(9):e40828. doi: 10.2196/40828.

  PMID: 36083608 DERIVED

Results Point of Contact

• Title: Jody R. Lori PhD, Associate Dean for Global Affairs, Director, PAHO/WHO Collaborating Center
• Organization: University of Michigan, School of Nursing

jrlori@med.umich.edu

734-763-0097

Study Officials

• John EO Williams

  Dodowa Health Research Centre

  STUDY DIRECTOR

• Jody R Lori, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Associate Dean for Global Affairs

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 25, 2019
• Study Start: July 29, 2019
• Primary Completion: August 18, 2022
• Study Completion: June 26, 2023
• Last Updated: June 7, 2024
• Results First Posted: September 28, 2023

Record last verified: 2024-05

Locations

GH (14)