Antenatal CareGRANDNCT04033003
Group Antenatal Care and Delivery Project
A study testing Group ANC in people with Antenatal Care, run by University of Michigan at 14 sites in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Antenatal Care
- What is being tested?
- Group ANC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,761 participants
- Where
- 14 sitesGhana
- Study dates
- 29 Jul 2019to 26 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Ghana14 sites
Adawso Health Center
Adawso
Adukrom Health Center
Adukrom
Klo Agogo Polyclinic
Agogo
Abiriw Clinic
Akropong
St Martin's Hospital
Akropong
Akuse Hospital
Akuse
Nkurakan Health Center
Koforidua
Tetteh Quarshie Hospital
Mampong
Adoagyiri Health Center
Nsawam
Djankrom Health Center
Nsawam
Nsawam Health Center
Nsawam
Nsawam Hospital
Nsawam
Atua Hospital
Somanya
Somanya Polyclinic
Somanya
About this study
Official title: Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial
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.
Read the 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:
- Increased BPCR, including recognition of danger signs and knowledge of how to respond to such signs
- 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
- 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
- Being tested
- Group ANC
- Keywords
- Antenatal care, Sub-Saharan Africa, Ghana
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ANCBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Group ANC |
| Stand ANC | No intervention | Individual standard antenatal care delivered at health facilities in Ghana |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T2 (6-12 weeks after delivery)
Place of Delivery
Place of delivery will be measured using a self-report question (facility delivery, home delivery).
Measured: 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.
Measured: 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.
Measured: T2 (6-12 weeks after delivery)
Birth Outcome
Birth outcomes will be self-reported and measured as stillbirth, live birth, early neonatal mortality.
Measured: 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.
Measured: T0 (Baseline at recruitment) and T2 (6 - 12 weeks postdelivery)
Secondary outcomes (11)
Change in Ability to Identify Postpartum Danger Signs for Mother
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 T0 (baseline) and T1 (34 weeks gestation - 3 weeks postdelivery).
There is no validated or standardized instrument to measure postpartum danger signs. The measure used in this study is an open-end question: What are the danger signs for you, the mother, after the baby is born? 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.
Measured: 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
Ability of mother to identify recommended action steps in response to danger signs that may occur before or after delivery. There is no validated or standardized instrument to measure this outcome, therefore the measure used in this study is the question: What do you think you would do if you have any of these (danger signs)? Responses are coded as Go to hospital or health facility CHECKED (1) or Go to hospital or health facility NOT CHECKED (0). Reported results are the sum of individual responses; higher score "Go to hospital checked" means a better outcome.
Measured: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Change in Knowledge of Family Planning Methods
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.
There is no validated or standardized instrument to measure this outcome, therefore the measure used in this study is an open-end 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 T0 (baseline) and T1 (34 weeks gestation - 3 weeks postdelivery). There are 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.
Measured: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Change in Intent to Use Family Planning
Intent to use family planning methods will be measured by self-report using a binary (yes/no) question that asks participants, "Do you intend to use family planning after delivery?". Responses are coded as yes = 1 or no = 0. A higher number equals those who indicated yes to 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 T0 (baseline) to T1( 34 weeks gestation - 3 weeks postdelivery).
Measured: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Change in Uptake of Family Planning
Uptake of family planning will be measured by self-report using a binary (yes/no) question that asks participants if they are currently using any family planning method. Responses are coded as yes = 1 or no = 0. A higher number equals those who indicated "yes" to currently using family planning. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum).
Measured: T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum)
Change in Interpersonal Violence
Experiences of physical, sexual, and emotional violence were measured using an investigator-derived questionnaire that asks participants if they experienced violence in the past year, and if resources and support are available to them. Raw item scores are a sum of individual responses; scores range from 0 to 9. 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 T4. Higher score means higher rates of reported sexual and emotional violence and lower access to resources and support.
Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 (baseline) to T4 (11 - 14 months postpartum)
Measured: T0 (baseline) and T4 (11 - 14 months postpartum)
Experience of ANC Care
Experience of ANC care is measured using a twenty-one item investigator-derived 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. Raw item scores are a sum of individual responses; scores range from 0 to 21. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome.
Measured: T2 (6-12 postpartum)
Completion of IPTp2 Malaria Prophylaxis During Pregnancy
Data gleaned from the participant's ANC/health record will be used to measure affirmative completion of IPTp2 malaria prophylaxis during pregnancy.
Measured: T1 (34 weeks gestation - 3 weeks postdelivery)
Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy
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.
Measured: T1 (34 weeks gestation - 3 weeks postdelivery)
Newborn Weight
Newborn weight in grams; these data will be retrieved from the participant's ANC/health card and measured as newborn weight.
Measured: T2 (6-12 weeks postpartum)
Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl).
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).
Measured: T2 (6 - 12 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start29 Jul 2019
- Primary completion18 Aug 2022
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Antenatal CareStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,761 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Dodowa Health Research Centre, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jody Rae Lori, University of Michigan
- Investigators
- John EO Williams, Study director, Dodowa Health Research CentreJody R Lori, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033003
- Sponsor's protocol ID
- HUM00161464
- Other IDs
- R01HD096277
- Acronym
- GRAND
- Status last verified
- May 2024
- First submitted
- 8 Jul 2019
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41091707Apetorgbor 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.
PubMed 39558280Kukula 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.
PubMed 39152408Lori 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.
PubMed 36083608
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04033003
- Acronym / sponsor ID
- GRAND / HUM00161464
- Conditions
- Antenatal Care
- Keywords
- Antenatal care, Sub-Saharan Africa, Ghana
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,761 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Dodowa Health Research Centre, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Increased BPCR, including recognition of danger signs and knowledge of how to respond to such signs
- 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
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ANC | Experimental | Behavioral: Group ANCIntervention 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. |
| Stand ANC | No intervention | –Individual standard antenatal care delivered at health facilities in Ghana |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group ANCIntervention 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. | Behavioural | Group ANC |
Primary outcome
Change in Ability to Identify Danger Signs in Pregnancy
Time frame: T0 Baseline (at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
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.
Change in Birth Preparedness and Complication Readiness
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
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.
Change in Ability to Identify Newborn Danger Signs
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
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.
Attendance of ANC Visits
Time frame: T2 (6-12 weeks after delivery)
Attendance of 4 or more ANC visits will be gleaned from data reported on the participant's ANC/health card.
Place of Delivery
Time frame: T2 (6-12 weeks after delivery)
Place of delivery will be measured using a self-report question (facility delivery, home delivery).
Attendance at Postpartum Check-ups for Mother
Time frame: T2 (6-12 weeks after delivery)
Attendance of postpartum check-ups will be gleaned from information on the participant's ANC/health card.
Attendance at Postnatal Check-up for Newborn
Time frame: T2 (6-12 weeks after delivery)
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.
Birth Outcome
Time frame: T2 (6-12 weeks after delivery)
Birth outcomes will be self-reported and measured as stillbirth, live birth, early neonatal mortality.
Change in Health Literacy
Time frame: T0 (Baseline at recruitment) and T2 (6 - 12 weeks postdelivery)
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.
11 secondary outcomes
Change in Ability to Identify Postpartum Danger Signs for Mother
Time frame: 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
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Change in Knowledge of Family Planning Methods
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Change in Intent to Use Family Planning
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Change in Uptake of Family Planning
Time frame: T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum)
Change in Interpersonal Violence
Time frame: T0 (baseline) and T4 (11 - 14 months postpartum)
Experience of ANC Care
Time frame: T2 (6-12 postpartum)
Completion of IPTp2 Malaria Prophylaxis During Pregnancy
Time frame: T1 (34 weeks gestation - 3 weeks postdelivery)
Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy
Time frame: T1 (34 weeks gestation - 3 weeks postdelivery)
Newborn Weight
Time frame: T2 (6-12 weeks postpartum)
Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl).
Time frame: T2 (6 - 12 weeks postpartum)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41091707Lanyo 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.
- Derived from this study: PubMed 39558280Apetorgbor 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.
- Derived from this study: PubMed 39152408Kukula 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.
- Derived from this study: PubMed 36083608Lori 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John EO Williams study director
Dodowa Health Research Centre
Jody R Lori, PhD principal investigator
University of Michigan
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group ANC in people with Antenatal Care, run by University of Michigan at 14 sites in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ability to Identify Danger Signs in Pregnancy (time frame: T0 Baseline (at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04033003, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.