Group Antenatal Care and Delivery Project

NCT ID: NCT04033003

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1761 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2023-06-26

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.

Detailed Description

We are at a critical time to examine new, innovative strategies to promote healthy pregnancy and optimize maternal and newborn outcomes. Generating successful strategies will require careful examination of existing service delivery models, challenging the current structure of care provision. One aspect of care, recently identified by the World Health Organization, which merits further research, is group antenatal care (ANC).

Since ANC is widely available and attended by the majority of pregnant women in Ghana without the expected impact on birth outcomes, it is vital to examine the way antenatal health messages are delivered. Pregnant women must receive health information that is accurate and easy to understand for them to make informed choices to improve their health and the health of their baby. 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. Interactions during ANC provide the opportunity to identify and treat numerous problems, as well as providing a setting to improve women's health literacy. Patients must receive health messages in a manner that allows them to process and evaluate the information and ultimately use it to impact their own health.

The effectiveness of ANC depends on the multidimensional concept of health literacy. Initially considered only as a patient's ability to read and understand written information, it is now more broadly defined as a person's ability to acquire or access information, understand it, and use the information in ways that promote and maintain good health. Despite a burgeoning emphasis on health literacy in high resource countries, there are a dearth of studies examining interventions to improve health literacy in low-resource settings. Even fewer studies have examined maternal health literacy, defined as the "cognitive and social skills which determine the motivation and ability of women to gain access to, understand, and use information in ways that promote and maintain their health and that of their children''. New approaches to improve health literacy are sorely needed in countries where women and newborns continue to die from preventable causes.

Antenatal care has been delivered the same way for decades. Clinics and hospitals in low-resource countries are notorious for providing ethnocentric care, privileging northern medical values at the expense of traditional and community values. Yet health literacy is affected by the cultural context in which learning takes place, including, but not limited to, belief systems, traditions, understanding, and communication styles. Transmitting health information in a clinical setting often fails to take into account the social and economic circumstances of patients, therefore not achieving the expected impact on health behaviors. This divide has contributed to a lack of progress in reaching the most vulnerable populations. If pregnant women do not receive health messages in a comprehensible way, they cannot effectively maximize the benefits of the health system. Substantially improving women's ability to understand and utilize health information is of utmost importance if we are to reach the global targets of 70 maternal deaths per 100,000 live births by 2030 and a neonatal mortality rate of 12 per 1000 live births set by WHO/USAID.

The investigators hypothesize that pregnant women randomized into group ANC will exhibit increased health literacy through:

1. Increased 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

3. Better clinical outcomes for themselves and their newborns than women who received the routine, individual ANC.

The intervention consists of nine meetings; one individual meeting and eight group meetings. At the initial ANC visit, women are assigned to a small groups with up to14 women of similar gestational age. Women meet individually with the midwife and the standard history and physical exam as well as lab tests are completed; group visits start at the second ANC visit. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. The midwife, health facility staff member, and patients then sit in circle facing one another for a 60-90 minute facilitated discussion. The health facility staff member will assist the midwife with group activities. The model uses strategies such as story-telling, peer support, and demonstration and teach-back to enhance its effectiveness. Health literacy is incorporated as an integral part of clinical practice within the model - not as an add-on to care.

Conditions

Antenatal Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 Type: EXPERIMENTAL

Group ANC

Intervention Type: 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.

Stand ANC

Individual standard antenatal care delivered at health facilities in Ghana

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dodowa Health Research Centre

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jody Rae Lori

Professor & Associate Dean for Global Affairs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John EO Williams

Role: STUDY_DIRECTOR

Dodowa Health Research Centre

Jody R Lori, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Adawso Health Center

Adawso, , Ghana

Adukrom Health Center

Adukrom, , Ghana

Klo Agogo Polyclinic

Agogo, , Ghana

Abiriw Clinic

Akropong, , Ghana

St Martin's Hospital

Akropong, , Ghana

Akuse Hospital

Akuse, , Ghana

Nkurakan Health Center

Koforidua, , Ghana

Tetteh Quarshie Hospital

Mampong, , Ghana

Adoagyiri Health Center

Nsawam, , Ghana

Djankrom Health Center

Nsawam, , Ghana

Nsawam Health Center

Nsawam, , Ghana

Nsawam Hospital

Nsawam, , Ghana

Atua Hospital

Somanya, , Ghana

Somanya Polyclinic

Somanya, , Ghana

Countries

Ghana

References

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.

Reference Type: DERIVED

PMID: 41091707 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39558280 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39152408 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36083608 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01HD096277

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00161464

Identifier Type: -

Identifier Source: org_study_id