Clinical trial NCT04033003: Group Antenatal Care and Delivery Project
Official title: Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antenatal Care
Keywords: Antenatal care
Sub-Saharan Africa
Ghana
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Dodowa Health Research Centre
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-07-25
Enrollment: 1761
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Ability to Identify Danger Signs in Pregnancy
timeFrame: T0 Baseline (at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
measure: Change in Birth Preparedness and Complication Readiness
timeFrame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
measure: Change in Ability to Identify Newborn Danger Signs
timeFrame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
measure: Attendance of ANC Visits
timeFrame: T2 (6-12 weeks after delivery)
measure: Place of Delivery
timeFrame: T2 (6-12 weeks after delivery)
measure: Attendance at Postpartum Check-ups for Mother
timeFrame: T2 (6-12 weeks after delivery)
measure: Attendance at Postnatal Check-up for Newborn
timeFrame: T2 (6-12 weeks after delivery)
measure: Birth Outcome
timeFrame: T2 (6-12 weeks after delivery)
measure: Change in Health Literacy
timeFrame: T0 (Baseline at recruitment) and T2 (6 - 12 weeks postdelivery)
Secondary outcomes:
measure: Change in Ability to Identify Postpartum Danger Signs for Mother
timeFrame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
measure: Change in Ability to Identify the Recommended Action Steps When a Problem is Identified
timeFrame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
measure: Change in Knowledge of Family Planning Methods
timeFrame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
measure: Change in Intent to Use Family Planning
timeFrame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
measure: Change in Uptake of Family Planning
timeFrame: T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum)
measure: Change in Interpersonal Violence
timeFrame: T0 (baseline) and T4 (11 - 14 months postpartum)
measure: Experience of ANC Care
timeFrame: T2 (6-12 postpartum)
measure: Completion of IPTp2 Malaria Prophylaxis During Pregnancy
timeFrame: T1 (34 weeks gestation - 3 weeks postdelivery)
measure: Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy
timeFrame: T1 (34 weeks gestation - 3 weeks postdelivery)
measure: Newborn Weight
timeFrame: T2 (6-12 weeks postpartum)
measure: Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl).
timeFrame: T2 (6 - 12 weeks postpartum)
Other outcomes:
Locations:
city: Adawso
country: Ghana
facility: Adawso Health Center
city: Adukrom
country: Ghana
facility: Adukrom Health Center
city: Agogo
country: Ghana
facility: Klo Agogo Polyclinic
city: Akropong
country: Ghana
facility: Abiriw Clinic
city: Akropong
country: Ghana
facility: St Martin's Hospital
city: Akuse
country: Ghana
facility: Akuse Hospital
city: Koforidua
country: Ghana
facility: Nkurakan Health Center
city: Mampong
country: Ghana
facility: Tetteh Quarshie Hospital
city: Nsawam
country: Ghana
facility: Adoagyiri Health Center
city: Nsawam
country: Ghana
facility: Djankrom Health Center
city: Nsawam
country: Ghana
facility: Nsawam Health Center
city: Nsawam
country: Ghana
facility: Nsawam Hospital
city: Somanya
country: Ghana
facility: Atua Hospital
city: Somanya
country: Ghana
facility: Somanya Polyclinic
Study officials:
affiliation: Dodowa Health Research Centre
name: John EO Williams
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Jody R Lori, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.