Group Antenatal Care and Delivery Project (GRAND)

• ClinicalTrials.gov Identifier: NCT04033003
• Recruitment Status: Active, not recruiting
• First Posted: July 25, 2019
• Last Update Posted: January 6, 2022
• Sponsor: University of Michigan
• Collaborators: Dodowa Health Research Centre; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Jody Rae Lori, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Antenatal Care	Behavioral: Group ANC	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1680 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial
• Actual Study Start Date: July 29, 2019
• Estimated Primary Completion Date: December 5, 2022
• Estimated Study Completion Date: August 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Stand ANC; Individual standard antenatal care delivered at health facilities in Ghana

Outcome Measures

Primary Outcome Measures :

1. Change in ability to identify danger signs in pregnancy [ Time Frame: Baseline and 3rd trimester ]
   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.). Change will be measured by calculating the difference in the mean at baseline and 3rd trimester.
2. Change in birth preparedness and complication readiness [ Time Frame: Baseline and 3rd trimester ]
   Change in the ability to identify a strategy for birth preparedness and complication readiness will be measured using a binary response (yes/no) to questions 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. Modified from the Birth Preparedness and Complication Readiness Index
3. Change in ability to identify newborn danger signs [ Time Frame: Baseline and 3rd trimester ]
   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 baseline and 3rd trimester.
4. Attendance of ANC visits [ Time Frame: 6 weeks post-delivery ]
   Attendance of 4 or more ANC visits will be gleaned from data reported on the participant's ANC/health card.
5. Place of delivery [ Time Frame: 6 weeks post-delivery ]
   Place of delivery will be measured using a self-report question (facility delivery, home delivery).
6. Attendance at postnatal/postpartum check-ups for mother and newborn [ Time Frame: 6 weeks post-delivery ]
   Attendance of postnatal/postpartum check-ups will be gleaned from information on the participant's ANC/health card using a measure of 3 visits before 6 weeks for newborns and mothers.
7. Birth outcome [ Time Frame: 6 week post-delivery ]
   Birth outcomes will be self-reported and measured as stillbirth, live birth, early neonatal mortality.
8. Change in Health Literacy [ Time Frame: Baseline and 6 weeks post-delivery ]
   Change in Health Literacy will be measured using the Maternal Health Literacy Scale, a 12-item composite scale.The MaHeLi Scale is a validated measure that uses composite scores to measure health-seeking behaviors, competence and coping skills, and appraisal of health information. Change over time will be analyzed using between group analysis and calculating the difference in the mean from baseline to 6 weeks post-delivery.

Secondary Outcome Measures :

1. Change in ability to identify postpartum danger signs for mother [ Time Frame: Baseline and 3rd trimester ]
   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 baseline and 3rd trimester.
2. Change in ability to identify the recommended action steps when a problem is identified [ Time Frame: Baselin) and 3rd trimester ]
   Ability of mother to identify recommended action steps in response to danger signs will be measured by self-report using a question that asks participants to identify care-seeking behaviors to respond to danger signs that may occur before or after delivery (e.g. call for help, go to the hospital or health facility, identify someone to accompany you to the facility). Change will be measured by calculating the difference in the mean at baseline and 3rd trimester.
3. Change in knowledge of family planning methods [ Time Frame: Baseline and 3rd trimester ]
   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.
4. Change in intent to use family planning [ Time Frame: Baseline and 3rd trimester ]
   Intent to use family planning methods will be measured by self-report using a binary (yes/no) question that asks participants 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 baseline to 3rd trimester
5. Change in uptake of family planning [ Time Frame: 6 weeks post-delivery, 6 months post-delivery, and 1 year post-delivery ]
   Uptake of family planning will be measured by self-report using a questionnaire that asks participants if they are currently using family planning after delivery. Change over time will be analyzed using between group analysis and calculating the difference in the mean from baseline to 3rd trimester
6. Change in interpersonal violence [ Time Frame: Baseline and 1 year post-delivery ]
   Interpersonal violence will be measured by self-report using a binary (yes/no) questionnaire that asks participants if they experienced violence in the past year, and if resources and support are available to them. Change over time will be analyzed using between group analysis and calculating the difference in the mean from baseline to 3rd trimester
7. Experience of ANC care [ Time Frame: 6 weeks post-delivery ]
   Experience of ANC care will be measured by self-report using a binary (yes/no) 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.
8. Completion of IPTp2 malaria prophylaxis during pregnancy [ Time Frame: 3rd Trimester ]
   Data gleaned from the participant's ANC/health record will be used to measure affirmative completion of IPTp2 malaria prophylaxis during pregnancy.
9. Completion of least two tetanus toxoid vaccines during pregnancy [ Time Frame: 3rd trimester ]
   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.
10. Newborn weight in kg [ Time Frame: 6 weeks post-delivery ]
    Newborn weight in kg; these data will be retrieved from the participant's ANC/health card and measured as newborn weight in kg.
11. Mother's hemoglobin at delivery in grams per deciliter (g/dl). [ Time Frame: 6 weeks post-delivery ]
    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).

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Study for pregnant women
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Ghana

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

Sponsors and Collaborators

University of Michigan

Dodowa Health Research Centre

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

Investigators

• Study Director: John EO Williams; Dodowa Health Research Centre
• Principal Investigator: Jody R Lori, PhD; University of Michigan

More Information

• Responsible Party: Jody Rae Lori, Professor & Associate Dean for Global Affairs, University of Michigan
• ClinicalTrials.gov Identifier: NCT04033003
• Other Study ID Numbers: HUM00161464; R01HD096277 ( U.S. NIH Grant/Contract )
• First Posted: July 25, 2019
• Last Update Posted: January 6, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jody Rae Lori, University of Michigan:

Antenatal care; Sub-Saharan Africa; Ghana