Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial
Phase: NA
Conditions: Antenatal Care
Sponsor: University of Michigan

Protocol: Ver. 3 July 17, 2019 
Group Antenatal Care -  Dodowa, Ghana 
 
 
Group Antenatal Care to Promote a Healthy 
Pregnancy and Optimize Maternal and Newborn 
Outcomes: A Cluster Randomized Controlled Trial 
 
 
 
 
 
Principal Investigators: Jody Lori, PhD, University of Michigan and 
Dr. John Williams, Dodowa Health Research Centre 
Co-investigators: Cheryl Moyer, PhD, University of Michigan 
Study Sponsor: National Institutes of Health; Eunice Kennedy Shriver 
National Institute of Child Health & Human Development. Grant#: 
RO1HD096277 
ClinicalTrials.gov: ID#: NCT04033003

Protocol: Ver. 3 July 17, 2019 
Group Antenatal Care -  Dodowa, Ghana 
 
Table of Contents 
1.0 Background and Rationale ...................................................................................................................... 3 
1.1 Ghanaian Context ............................................................................................................................... 4 
1.2 Scientific Premise ................................................................................................................................ 4 
2.0 Aims and Objectives ................................................................................................................................ 5 
3.0 Research Methods and Study Design ..................................................................................................... 6 
3.1 Recruitment and Informed Consent ................................................................................................... 6 
3.2 Inclusion/Exclusion Criteria ................................................................................................................. 7 
3.3 Data Collection and Measures ............................................................................................................ 8 
3.4 Process Evaluation ............................................................................................................................ 10 
3.5 Intervention - Description of the Model for Group Antenatal Care ................................................. 11 
3.6 Control - Antenatal Care as Usual ..................................................................................................... 12 
3.7 Randomization .................................................................................................................................. 13 
4.0 Data Analysis (Aims 1-3) ....................................................................................................................... 13 
4.1 Data Analysis (Process Evaluation): .................................................................................................. 14 
4.2 Risks or Discomforts and Benefits..................................................................................................... 15 
4.3 Incentives .......................................................................................................................................... 15 
4.4 Confidentiality of Data, Processes for Anonymizing Data ................................................................ 15 
4.5 Data Storage and Management ........................................................................................................ 16 
4.6 Long-term data storage and management; Clarity of data ownership ............................................ 16 
5.0 Ethical considerations ........................................................................................................................... 16 
 

Protocol: Ver. 3 July 17, 2019 
Group Antenatal Care -  Dodowa, Ghana 
 
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1.0 Background and Rationale 
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 (GANC). 
Antenatal care has the potential to play a pivotal role in ensuring positive pregnancy outcomes for 
both mothers and their newborns. 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 

Protocol: Ver. 3 July 17, 2019 
Group Antenatal Care -  Dodowa, Ghana 
 
Page 4 
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.  
 
1.1 Ghanaian Context 
In 2015, the maternal mortality ratio in Ghana was estimated at 319 per 100,000 live births – 
placing a woman’s lifetime risk of maternal death at 1 in 74, compared to 1 in 3,800 in the United 
States.  In 2014, while 87.3% of women in Ghana surveyed had attended the minimum standard of 
4 antenatal care (ANC) visits, 27% gave birth alone or with a non-skilled attendant. Sixty-eight 
percent of all deaths among children under age 5 in Ghana happen before a child’s first birthday, 
with 48% of deaths occurring in the first month of life - making the first 28 days in an infant’s life 
crucial for survival.  Only 22.8% of newborns received the recommended postnatal check-up 
within the first two days of life between 2012-2014 in Ghana.  It should be noted that since 2008 
there has been only a marginal decline (3%) in neonatal mortality within Ghana.  Ghana is now 
one of 24 priority countries targeted by the United States Agency for International Development 
(USAID) to improve maternal and child health and end preventable deaths. 
1.2 Scientific Premise 
Research has shown community-based women’s groups in low-resource settings catalyze action, 
provide supportive networks, educate and empower, and lead to substantial increases in neonatal 
survival. Women’s groups at the community level have been found to devise their own culturally 
appropriate strategies for prevention of newborn problems, home care support, consultation and 
referral. Women participating in community groups in Guinea showed an increase in maternal 
health care-seeking behaviors; with women in community groups more than twice as likely to 
attend four ANC visits, seek care for signs of complications, and given birth in a health facility. A 
rigorous systematic review and meta-analysis of seven randomised control trials (119,428 births) 
found women’s groups at the community level were associated with a 37% reduction in maternal 
mortality, a 23% reduction in neonatal mortality, and a 9% reduction in sitllbirths. [22]   
 
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.  Two 
randomized controlled trials of group ANC using a U.S group-based model verses routine care 
found women assigned to group care had significantly better antenatal knowledge, greater 
satisfaction with care, and were less likely to have a preterm birth than those in standard care. In 
addition, the trials showed more favorable birth, neonatal, and reproductive outcomes in the 
intervention groups.  Although the experimental design of the studies from high-resource countries 
were scientifically rigorous, findings cannot be generalized to low-resource countries with low 
literacy rates and high rates of maternal and newborn morbidity and mortality.  In sub-Saharan 
Africa, data from two small studies found ANC delivered in groups to be acceptable and feasible 
to both women and providers in Ghana, Tanzania, and Malawi.  In the U.S., Australia, and the 
Netherlands, group ANC has improved outcomes in birth weight, preterm birth rates, satisfaction 
with care, and breastfeeding initiation.  

Protocol: Ver. 3 July 17, 2019 
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2.0 Aims and Objectives 
Aim 1: To quantify differences in BPCR, knowledge of pregnancy and newborn danger signs 
and recommended action steps.  
Primary Outcomes 
• Ability to identify danger signs in pregnancy (e.g. bleeding, severe headache, 
blurred vision, fever) 
• Birth preparedness and complication readiness (e.g. saved money, identified birth 
facility and emergency transportation to facility, blood donor)  
• Ability to identify newborn danger signs (e.g. poor suck, jaundice, difficulty/fast 
breathing, and convulsions)    
 
Secondary Outcomes 
• Ability to identify postpartum danger signs (e.g. increased bleeding or large 
clots; weakness/fainting; fever; pain in abdomen or breasts; painful urination)  
• Ability to identify the recommended action steps when a problem is identified 
(e.g. call for help, have a plan for transportation, identify someone to accompany 
you to facility, identify someone to care for the family, go straight to the facility, 
supportive care along the way to the facility)   
• Self-efficacy operationalized care-seeking history and health information 
knowledge    
Aim 2: To assess behavioral differences in care-seeking patterns (e.g. facility birth rates, 
postnatal and postpartum care)  
 
 
Primary Outcomes 
• Attendance at 4+ ANC visits  
• Facility birth  
• Four postnatal/postpartum check-ups for both mother and newborn in the first 6 
weeks after birth  
 
Secondary Outcomes 
• Uptake of modern family planning methods at 6 months postpartum  
• Infant immunized per EPI scheduled at 1 year   
• Completion of IPTp2 malaria prophylaxis during pregnancy  
Aim 3: To evaluate the clinical outcomes of mothers and their newborns (e.g. decrease in 
maternal morbidities and perinatal and neonatal mortality)   
 
Primary Outcomes 
• Maternal pregnancy-related morbidities (puerperal sepsis, delayed postpartum 
hemorrhage)  
• Birth outcome (stillbirth, live birth, early neonatal mortality)  
 
Secondary Outcomes 
• At least two tetanus toxoid vaccines during ANC  

Protocol: Ver. 3 July 17, 2019 
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• Infant protected against neonatal tetanus  
• Hemoglobin level upon hospital admission (dichotomized as normal or anemic 
(<9.5 g/dL)  
• Infant birth weight (normal vs. low (<2500g)  
• Repeat pregnancy within one year  
• Exclusive breastfeeding at 6 months  
 
We 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; and 3) better clinical outcomes for themselves and their newborns 
than women who received the routine, individual ANC.  
3.0 Research Methods and Study Design 
To accomplish our aims we propose a cluster randomized controlled trial (cRCT) in the Eastern 
District of Ghana. The study is designed in collaboration with the Dodowa Health Research Center 
under the direction of John Williams (Co-PI). Health facilities were selected based the number of 
deliveries and average gestational age of women in each facility and matched so that each pair of 
facilities are similar to each other with regard to these matching factors. For each pair of facilities, 
one will randomly be assigned to group ANC (intervention) and the other to routine, individual 
ANC (control). The locations of the chosen facilities ensure that participating facilities will be far 
enough apart to minimize the likelihood of cross-group contamination. The unit of randomization 
is the health facility stratified by site and gestational age. Cluster randomization will be produced 
through nbpMatching package from R software. During the study, 1680 participants will be 
randomized into 120 groups of 12 to 14 women of the same gestational age at the cluster site. This 
will result in approximately 8-10 groups per site during the study period.  
 
3.1 Recruitment and Informed Consent 
Recruitment of women will occur at individual health facilities. The research staff will work with 
clinic staff to identify women who meet the eligibility criteria and are healthy enough to discuss 
enrolling in an ANC intervention. The RA will inform health facility staff when they will be at 
the clinic and available to women interested in learning more about the study. Midwives will 
identify women who are: 1) less than 20 weeks gestation; 2) speak Dangme, Ga, Aka, Ewe, or 
English; 3) over the age of 15; and 4) are not considered high risk. Thus, the midwife (as a 
medical professional) will make the assessment that a woman is healthy enough to participate in 
the study. 
The midwife will instruct women who qualify to should talk to the RA if they are interested in 
learning more about the study. Women who approach the RA will be read an approved 

Protocol: Ver. 3 July 17, 2019 
Group Antenatal Care -  Dodowa, Ghana 
 
Page 7 
recruitment script. Those who are willing to participate will be taken through an informed 
consent procedure and will then complete baseline data collection.  
Due to the high rates of illiteracy in Ghana, we will ask for a waiver of the standard written 
informed consent procedure. Instead, oral consent will be obtained individually from all 
participants and witnessed. The procedures for informed consent will include: 1) We will 
prepare an informed consent document in English that will be translated into Dangme, Ga, Akan, 
and Ewe; 2) The informed consent document will be read aloud individually to all potential 
participants in private; 3) The Ghanaian RA will ask the potential participant questions to ensure 
understanding of the research process and informed consent document and will invite questions 
until the information is clear; and 4) as we anticipate that many participants will not be able to 
read the form themselves, a witness (health facility staff) will sign that he/she was present while 
the benefits, risks, and procedures were read to the participant, that all questions were answered, 
and that women  voluntarily agreed to take part in the research. A teach-back method will be 
used to confirm participant comprehension of the study requirements and methodology. The RA 
will ask potential participants to describe their understanding of the study’s purpose, procedure, 
risks, and benefits using open-ended prompts and repeating the material until understanding is 
achieved. 
The participant will sign, or mark with a thumbprint, the informed consent and the RA will use 
the camera on the encrypted tablet to take a shot of the signed/ thumbprint page. The image will 
be stored similar to all study data; that is, when internet connection is not available, data will be 
collected off-line and stored in a password protected file on the encrypted tablet. Once a 
connection is available, these data will be uploaded, managed, and stored on a secure server.  
Participants will be given  their signed/thumbprint informed consent that contains the following 
elements: title of project, name, credentials and institution of researcher, invitation to participate, 
statement that the study involves research, description of the research, description and length of 
participant involvement, benefits and risks, compensation, confidentiality, voluntary 
participation, and contact information.   
3.2 Inclusion/Exclusion Criteria 
Inclusion criteria are as follows: 1) willingness to participate in the study; 2) less than 20 weeks’ 
gestation 3) able to speak Dangme, Ga, Akan, Ewe, or English; 4) over the age of 15 years; and 5) 
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.  
In the eastern region, 10.4% of females age 15-49 have never attended school and only 15.7% 
percent have completed secondary school or higher. Thus, we will not limit participation based on 
literacy, however we will control for years of education and literacy status in the analysis. This is 
a study of an intervention for pregnant women to improve maternal and newborn outcomes; thus 
no males will be included.  

Protocol: Ver. 3 July 17, 2019 
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3.3 Data Collection and Measures  
All quantitative data will be collected by trained RAs using encrypted and password protected 
tablets and the REDCap secure web application for data collection database management. Redcap, 
a secure web application, is geared to support online or offline data capture for research studies. 
When internet connection is not available, data will be collected off-line and stored on the 
encrypted tablet. Once a connection is available, these data will be uploaded, managed, and stored 
on a secure server.    
No data will be collected by clinical providers. Data collection will occur at five time points in 
both intervention and control arms: 
1. Time 0: at ENROLLMENT (in person) 
2. Time 1: at THIRD TRIMESTER (in person) 
3. Time 2: POST BIRTH up to 6 weeks after delivery (in person) 
4. Time 3: SIX MONTHS POSTPARTUM (by phone) 
5. Time 4: ONE YEAR POSTPARTUM (by phone)  
 
1) T0: The baseline session occurs immediately following the consent process and will be 
held for approximately 1 hour. Data will be collected by trained RAs using a structured 
survey; medial information will be self-reported, and thus, are not protected health 
information (PHI).  
2) T1: This session will occur at the third trimester of pregnancy and will last  45 – 60 minutes. 
Data will be collected by trained RAs using a structured interview and retrieving data from 
the ANC card. Data collected from the ANC card are PHI and will be protected.  
3) T2: This session will occur in the period immediately to 6 week after delivery and will last  
45 – 60 minutes. Data will be collected by trained RAs using a structured interview and 
information from ANC cards on maternal and newborn clinical outcomes using a pre-
determined set of indicators.  
4) T3: This session will occur 6-months postpartum; data will be collected via phone by a 
trained RAs using a structured interview. This session will take approximately 20 - 30 
minutes.  
5) T4: This session will occur 1-year postpartum; data will be collected via phone  by a trained 
RAs using a structured interview.  This session will take approximately 20 - 30minutes. 
 
During all visits midwives will record Clinical Health Related Outcomes (Place of birth, 
hemoglobin levels, newborn birth weight, maternal & newborn morbidities, stillbirth, postpartum 
visit within 2 days post birth) on the women’s ANC card. These data will be collected by the RA 
during all study visits except baseline.  
 
 

Protocol: Ver. 3 July 17, 2019 
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Measures 
 
 
 
Time Point 
Domain 
Data collection 
T0 – 
Baseline 
Demographic Characteristics  
(Age, gravida, living children, marital status, age at marriage, 
pregnancy history, medical history) 
Face-to-face Survey   
 
Self-efficacy 
 
 
Recognize problems and understands health information 
Face-to-face Survey   
 
Care-seeking history 
Face-to-face Survey   
 
Educational Background 
 
 
Level of Education 
Face-to-face Survey   
 
Prior Knowledge  
 
 
Ability to identify danger signs/BPCR 
Face-to-face Survey   
 
Health Literacy Skills 
(understanding, engagement with health system) 
Face-to-face Survey   
 
Ecological Influences 
(social support, community and family resources) 
Face-to-face Survey   
T1 – Third 
trimester 
Comprehension of Stimuli  
(identification of danger signs, BPCR) 
Face-to-face Survey   
 
Self-determination 
 
 
Intent to use family planning / preparation for birth 
Face-to-face Survey   
 
Two or more tetanus toxoid vaccines / Completion of ITP2 
malaria prophylaxis 
ANC Card 
T2 – Post 
birth 
Clinical Health Related Outcomes 
(Place of birth, hemoglobin levels, newborn birth weight, 
maternal & newborn morbidities, stillbirth, postpartum visit 
within 2 days post birth) 
ANC Card 
 
Self-determination 
 
 
Attendance at 4 or more ANC visits 
ANC Card 
 
Adherence to care - Number of ANC Visits 
ANC Card 
 
Health Related Behavior 
(Maternal and newborn postpartum visits) 
Survey 
 
Clinical Health Related Outcomes 
(Perinatal mortality (<7 days), maternal morbidities) 
ANC Card 
T3 – Six 
months 
postpartum 
Health Related Behavior 
(Uptake of modern family planning, exclusive breastfeeding, 4 
postnatal check-ups completed on both mother and newborn in 
first 6 weeks)  
Survey via phone 
 
Clinical Health Related Outcomes 
(Neonatal mortality(<28 days), maternal morbidities)  
Survey via phone 
T4 – One 
year 
postpartum 
Health Related Behavior  
(Repeat pregnancy) 
Survey via phone 
 
Clinical Health Related Outcomes 
(Infant immunized per EPI schedule; maternal morbidities)  
Self-report 
Survey via phone 

Protocol: Ver. 3 July 17, 2019 
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Page 10 
 
 
During all visits midwives will record Clinical Health Related Outcomes (Place of birth, 
hemoglobin levels, newborn birth weight, maternal & newborn morbidities, stillbirth, postpartum 
visit within 2 days post birth) on the women’s ANC card. These data will be collected by the RA 
during all study visits except baseline.  
3.4 Process Evaluation  
We will concurrently conduct a process evaluation to identify and document patient, provider, and 
system barriers and facilitators to program implementation. Using both quantitative and qualitative 
methods, we will identify potential and actual influences on the quality and conduct of the 
program's operations, implementation, and service delivery.  
 
Data Collection (Process Evaluation):  Process evaluation data will be collected via audiotaped 
semi-structured interviews with facility staff and women participating in GANC. Process 
evaluation data will include an assessment of both providers’ and women’s perceptions. 
 
All midwives (providers) involved in the intervention arm (GANC) will be asked to participate in 
the process evaluation. Midwives will be approached by the RA at the end of the 7th group meeting 
and asked if they are interested in providing feedback about group care. Those willing to participate 
will be taken through a consent process before the first interview begins. Each midwife will be 
interviewed at two random times and each interview will last approximately 40 minutes.  A 
structured interview using open-ended questions will be conducted to explore  the midwife’s 
perceptions of group versus standard ANC, barriers to implementation, challenges to integrating 
it into the existing clinic workflow, and strategies that have helped with implementation. 
Interviews will be audiotaped (with permission from the participant) to ensure accuracy of 
responses; midwives can refuse to be audiotaped yet continue with the interview. The RA will 
write short answer responses on a data collection form. Audio tapes will be transcribed and will 
be de-identified; tapes will be destroyed immediately after transcription. We have 7 health 
facilities randomized to the intervention arm and 2 to 4 midwives at each facility; As each midwife 
may be interviewed twice, we expect approximately 56 midwives may participate in the process 
evaluation. 
 
Groups of women in the intervention arm will be randomly selected to participate in focus groups 
for process evaluation. We anticipate 10 random groups of 10 women through the course of the 
study for a total of 100 women in focus groups. Women will be asked to describe their perceptions 
of group versus standard ANC, their perceptions of the value of group ANC, and how they could 
envision the process being improved. Each focus group discussion will last about 1 hour. Women 
will be given a small baby gift for their participation. 
 
We will employ structured observations of group sessions, interviews with providers, focus groups 

Protocol: Ver. 3 July 17, 2019 
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of women, and tracking logs to record how the intervention is delivered and received, document 
program fidelity, and identify opportunities to enhance the delivery of the intervention, while 
maximizing consistency in intervention delivery across sites. This process evaluation will add 
value to the analysis of the group ANC intervention by identifying barriers and facilitators at 
multiple levels throughout the study. For this process evaluation we will focus on both fidelity of 
the intervention and dose (or frequency). 
 
We will not conduct focus groups with women in the control arm or interviews with midwives at 
facilities in the control arm as the intent of the focus group is to glean information about women’s 
experience in GANC. 
 
Structured Observations: A sample of 2 of 7 group ANC visits will be observed for each provider 
to monitor fidelity to the model (e.g. if content is delivered as intended, women are engaged to 
actively participate in group discussions and activities, picture cards are used as written in the 
Facilitators Guide, feedback is provided to participants during demonstrations). 
 
Focus Groups: Focus group discussions will be led by the RA or study coordinator 
 with randomly selected groups of women completing GANC throughout the study. Focus groups 
participants will be consented individually before they enter the focus group room so they may 
choose whether they want to participate. The group will be conducted in a private setting, and 
names will not be used during the discussion. Participants will be reminded that the discussion is 
private and they should avoid discussing the focus with others outside the group. Focus groups 
will be audiotaped to ensure accuracy of responses. Women who do not want to be audiotaped will 
not be included in the focus group. Audio tapes will be transcribed and will be de-identified; tapes 
will be destroyed immediately after transcription. 
 
Tracking logs: A brief form completed by the provider each time an ANC visit is held to track 
the date of the session and the number of participants from the group in attendance (to track dose). 
 
3.5 Intervention - Description of the Model for Group Antenatal Care 
The group ANC model was modified from a curriculum initially developed by the American 
College of Nurse Midwives to mobilize communities in low-resource countries for early problem 
identification of pregnancy related problems and referral. Using an iterative process with 
Ghanaian providers, pregnant women, and stakeholders as well as content experts from the U.S. 
to ensure local and cultural relevance and the WHO Standards for Maternal and Neonatal Care, 
the group ANC model was developed and tested for acceptability and feasibility by Dr. Lori and 
her Ghanaian team for the first time in a clinical setting in Ghana. At the core of the model is a 
negotiation process that acknowledges some health messaging may be in conflict with cultural 
beliefs.  The model allows participants to incorporate safe, feasible, and culturally acceptable 
health beliefs into self-care actions by being inclusive of traditional practices that are not 

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Page 12 
harmful. Participants and the facilitator ‘agree’ on safe and acceptable actions within the context 
of the setting that are then practiced by the group.  
  
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 12-14 women of similar 
gestational age.  Women meet individually with the midwife and the standard complete 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.  
 Evidence-based information is presented in a non-hierarchical, patient centered, participatory 
way.  Picture cards are used to enhance communication and learning in the group setting. They 
provide a mechanism to envision new concepts and ideas. The picture cards provide a valuable 
group discussion and learning aid to stimulate thinking and reflection, dialogue, and learning 
among participants.  A Take Action Card booklet comprised of pictures corresponding to each 
topic covered in the group sessions, is provided for each pregnant 
woman to take home and use as a reminder of problems and actions to 
take if problems arise. Women are encouraged to discuss and share 
the information with family members and friends - reinforcing what 
was learned during ANC visits. Content is repeated multiple times in 
a variety of ways to enhance retention, including:  1) auditory 
(listening to stories and signs of problems); 2) visual (through use of 
demonstration and picture cards); 3) kinesthetically (practicing 
actions and “handling” picture cards); and 4) the Take Action Card 
Booklet for home use.  
 A Facilitator’s Guide for Antenatal Care developed during the 
Fogarty-funded study in Ghana, provides a step-by-step guide that details how to conduct each 
of the group ANC visits care, becoming a facilitator, enhancing adult learning, respectful 
maternity care, and monitoring for program quality, performance, and fidelity.    
 
3.6 Control - Antenatal Care as Usual.  
The control arm is standard antenatal care delivered at health facilities in Ghana. During these 
visits women meet individually with a midwife who conducts a brief history and physical exam 
including weight and blood pressure. Following the standard ANC visit, women enrolled in the 
study at a control site will complete the same survey as the women in the intervention arm. 
Follow-up visits are the same across conditions.  

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3.7 Randomization 
There are 14 sites in the study. We randomized these 14 sites into the control group and the 
intervention group. To improve the balance between the two groups and improve the efficiency 
of estimating intervention effect, we used the facility type, district of site, and ANC registrant 
numbers in 2018 to conduct matched randomization. The randomization process were carried out 
using nbpMatching package from R software.  
Control Sites 
  
Intervention Sites 
Facility  
Facility Type 
District 
ANC 
2018 
  Facility  
Facility Type 
District 
ANC 
2018 
Adawso  
Health Center 
Akuapim North 
403 
  
Akuse  
Hospital 
Lower Manya 
Krobo 
378 
Abiriw 
Clinic 
Akuapim North 
322 
  
Adkukrom  Health Center 
Akuapim North 
299 
Tetteh Quarshie  
Hospital 
Akuapim North 
654 
  
Atua  
Hospital 
Lower Manya 
Krobo 
715 
St Martin's  
Hospital 
Lower Manya 
Krobo 
1081 
  
Nsawam  
Hospital 
Nsawam 
4930 
Nsawam  
Health Center 
Nsawam 
901 
Adoagyiri  
Health Center 
Nsawam 
817 
Djankrom  
Health Center 
Nsawam 
295 
Klo 
Agogo  
Polyclinic 
Yilo Krobo 
237 
Nkurakan  
Health Center 
Yilo Krobo 
469 
Somanya  
Polyclinic 
Yilo Krobo 
616 
 
 
4.0 Data Analysis (Aims 1-3) 
Data on all patients randomly assigned to the intervention or control groups will be analyzed on 
an intention-to-treat basis. Deviations from randomized allocation will be reported. Summary 
statistics based on mean, standard deviation or frequency will be used to characterize the sample 
distribution of each arm. Proper transformations will be investigated and taken if the sample 
distributions of continuous variables violate the normality assumption. For Aims 1-3, generalized 
linear mixed models (GLMMs) will be used to test the differences between the two arms since 
cluster randomized control design is used. There are four components in GLMMs: outcome 
variable, fixed effects, random effect, and link function.  The fixed effects include explanatory 
variable and covariates. In this study, all three aims have the same explanatory variable which is a 
binary variable indicating the arm to which women are assigned. The study sites, gestational age, 
and women’s demographic variables such as education or literacy, marital status, pregnancy 
history, and medical history will be added to the GLMMs as covariates to increase the precision 
of estimates. The random effect is the 14 facilities. In this study, a random intercept model will be 
used to account for the cluster effect. The outcome variables and link functions in GLMMs depends 
on aims and are described below. The construct of GLMMs is to test if the explanatory variable is 
significant at 0.05 level using likelihood ratio test.   
 

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For Aim 1 to quantify differences in the recognition of pregnancy and newborn danger signs and 
knowledge of recommended action steps, the BPCR Index will be measured at enrollment and 
third trimester. We will add baseline data as covariates. The logit link function will be used for 
each binary BPCR question to test the efficacy of the group-based ANC method. The identity link 
function will be used when the outcome variable is a summary statistic of the BPCR Index. When 
the p-value of the explanatory variable is less than 0.05, we will declare a significant difference 
between the two arms. Average changes in BPCR summary statistics or odds ratio in each question 
will be used to quantify the effect of the group-based ANC intervention. 
  
For Aim 2 of assessing behavioral differences in care-seeking patterns between the two arms, the 
outcome variables are number of attendances in ANC visits, facility birth, and postnatal/partum 
care. For the attendance outcome variable, identity function will be used. For facility birth or 
postnatal/partum care, the logit link function is used. When the p-value of the explanatory variable 
is less than 0.05, we will declare a significant difference between the two arms. The effect of 
group-based ANC on attendances is quantified by the average difference. The effects of group-
based ANC on facility birth and postnatal/partum care are quantified by odds ratio. For the 
secondary outcomes in aim 2, the logit or identity links will be used in the way similar to the 
primary outcomes.  
  
For Aim 3 to evaluate the clinical outcomes of mothers and their newborns, the outcome variables 
are maternal pregnancy-related morbidities and newborn birth status. For maternal morbidities, the 
logit link function is used. Since the newborn birth status is classified into three categories 
(stillbirth, live birth, and early neonatal mortality), cumulative logit link function is used. When 
the explanatory variable is significant at 0.05, the effect of group-based ANC on maternal 
pregnancy-related morbidities and newborn birth status are interpreted using odds ratio. We will 
illustrate the difference between outcomes using odds ratios for each pair of newborn birth status. 
The secondary outcomes are analyzed similarly using identity or logit link functions.   
 
For the multiple outcomes in the same family, we will conduct direct inference using the Holm’s 
multiple testing procedure to control familywise error rate at 0.05 level. The GLMM analysis will 
be carried out using lme4 package from R software. All findings will be reported using the 
Consolidated Standards of Reporting Trials (CONSORT) statement as a guide.  Full transparency 
will be provided when reporting experimental details so that others may reproduce and extend our 
findings.  We will register the study with clinicaltrials.gov and disclose all demographic and 
baseline characteristics, as well as primary and secondary outcomes. 
 
 
4.1 Data Analysis (Process Evaluation):   
Steckler et al. will guide our analysis of our process evaluation data.  Qualitative data will be 
obtained from semi-structured interviews. All qualitative data will be collected by trained RAs, 

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transcribed verbatim into English (leaving key phrases that are difficult to translate intact, with the 
closest approximate meaning put in parentheses in the transcription). No data will be collected by 
clinical providers. All transcripts will be stored on a password protected server.  All data from 
semi-structured interviews will be entered into N-Vivo qualitative software to assist with the 
identification of key themes. Structured observations will be recorded and summarized for key 
points.  The use of an audit trail composed of methodological and analytical documentation and 
validation with colleagues will be used to achieve validity.  
 
4.2 Risks or Discomforts and Benefits 
There are minimal risks to participants in this study. There is a rare risk of breach of confidentiality, 
emotional discomfort, and lack of privacy in the study that will be minimized as outlined below. 
For the survey portion of the study, participants will be informed in the informed consent as well 
as verbally in advance of the possibility of questions regarding sensitive subject matters that may 
make them feel uncomfortable. They will be told that they may skip any question that they find 
too distressing and/or withdraw from the survey at any time The Ghanaian RAs will be trained to 
monitor and to provide emotional support. If a participant experiences emotional discomfort while 
responding to the questions, the RAs will offer support, determine whether it is appropriate to 
continue and/or provide an appropriate local referral if needed. Local referrals sources will be 
determined in advance and supplied to the RAs at the time of the study. All forms will be retained 
by the Ghanaian RA in a locked office, transported to the US in a locked carry-on that is kept with 
the research team member at all times, and then will be stored in a secure location in a locked file 
cabinet in the locked office of the primary investigator at the University of Michigan after study 
completion to protect confidentiality.  
4.3 Incentives 
Incentives for participants will include baby layette items (e.g. baby hat, blanket, socks, tote bag) 
given at each time point. 
 
4.4 Confidentiality of Data, Processes for Anonymizing Data  
To maximize data confidentiality and participant protection in the proposed project, all project 
staff will be trained in these requirements and the importance of confidentiality emphasized on a 
regular basis.  Participant confidentiality will be protected in that we are not recording names of 
participants on any paper study material or data collection tools. All study materials will be stored 
in a locked space every evening and all data will be encrypted.  Data will be stored on an encrypted 
and password protected tablet in a locked space. 
Focus groups participants will be consented individually before they enter the focus group room 
so they may choose whether they want to participate. The group will be conducted in a private 
setting, and names will not be used during the discussion. Participants will be reminded that the 
discussion is private and they should avoid discussing the focus with others outside the group. 
Audio tapes will be transcribed and will be de-identified; tapes will be immediately destroyed after 
transcription. Prior to transcription, all tapes will be stored in a locked file cabinet in a locked 

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office in the Dodowa Health Research Center. Access to the cabinet will be restricted to study 
investigators and the DHRC study team. 
4.5 Data Storage and Management 
Data will be considered strictly confidential and will be entered into an electronic record using a 
secure tablet with password-protected access. Prior to data collection, tablets will be encrypted to 
ensure all data is securely stored. Once a tablet is encrypted, a one-time process that is initiated 
from the tablet's settings page, users will be asked to enter a pin every time the device is turned 
on and data will only be available when the device is unlocked. 
 
Data will be stored on a secure, cloud-based server, accessible only to trained members of the 
research team. No names will be included in any recorded data, instead using individual tracking 
numbers that will be kept in a separate encrypted data file for the purposes of long-term follow-
up.  There will be two contact lists:  first, a full contact list that contains the participant’s name, 
phone number, and study ID.  This paper list will be kept in a locked file cabinet in a locked 
office.  The second contact list (electronic list), for the purpose of study visits and data 
collection, will include only the participant’s first name and study ID number.  The RA will 
travel to the field for data collection carrying only a password protected file on the encrypted 
tablet to meet with participants.    
Access will be available only to study members working directly with participants for 
follow-up data collection.  We will destroy all links between respondents and survey data after 
project completion. Study material transported back to UM will be in a locked briefcase that will 
be carried onto the plane and remain with the research team at all times. 
 
4.6 Long-term data storage and management; Clarity of data ownership 
Upon completion of the project all data - stripped of any potential identifiers - will be kept in 
University of Michigan’s Deep Blue, a permanent, publically available data repository. 
5.0 Ethical considerations 
This study will begin after approval from the University of Michigan Health Sciences Behavioral 
Sciences Institutional Review Board (IRB) and Ghana Health Service.  An experienced, 
interdisciplinary and transnational team of researchers with a long-standing history of 
collaborations will carry out the proposed study. This innovative interdisciplinary group—nurse 
midwives, public health experts, and researchers from the United States and Ghana—bring a 
wealth of knowledge and skills to the proposed study. As required by the University of Michigan 
(regardless of the country of residence), all research staff, including principal investigators, 
coinvestigators, and research assistants on research projects that involve human study participants 
must complete the online Program for Education and Evaluation in Responsible Research and 
Scholarship (PEERRS) or equivalent, and must have their human subjects certification renewed 
every three years. The Ethics Boards at Ghana Health Services and DHRC are responsible to 
oversee the research activity of the DHRC study members.