Antenatal Care Clinical Trial
— GRANDOfficial title:
Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial
Verified date | May 2024 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1761 |
Est. completion date | June 26, 2023 |
Est. primary completion date | August 18, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: - willingness to participate in the study - less than 20 weeks' gestation 3) able to speak Dangme, Ga, Akan, Ewe, or English - over the age of 15 years Exclusion Criteria: - No history of medical problems that would indicate the participant might be considered "high risk" (e.g., hypertension, insulin-dependent diabetes mellitus) and thus requiring a more individualized approach to care. |
Country | Name | City | State |
---|---|---|---|
Ghana | Adawso Health Center | Adawso | |
Ghana | Adukrom Health Center | Adukrom | |
Ghana | Klo Agogo Polyclinic | Agogo | |
Ghana | Abiriw Clinic | Akropong | |
Ghana | St Martin's Hospital | Akropong | |
Ghana | Akuse Hospital | Akuse | |
Ghana | Nkurakan Health Center | Koforidua | |
Ghana | Tetteh Quarshie Hospital | Mampong | |
Ghana | Adoagyiri Health Center | Nsawam | |
Ghana | Djankrom Health Center | Nsawam | |
Ghana | Nsawam Health Center | Nsawam | |
Ghana | Nsawam Hospital | Nsawam | |
Ghana | Atua Hospital | Somanya | |
Ghana | Somanya Polyclinic | Somanya |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Dodowa Health Research Centre, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Ghana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
T0 Baseline (at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | |
Primary | 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. | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | |
Primary | 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. |
T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | |
Primary | Attendance of ANC Visits | Attendance of 4 or more ANC visits will be gleaned from data reported on the participant's ANC/health card. | T2 (6-12 weeks after delivery) | |
Primary | Place of Delivery | Place of delivery will be measured using a self-report question (facility delivery, home delivery). | T2 (6-12 weeks after delivery) | |
Primary | Attendance at Postpartum Check-ups for Mother | Attendance of postpartum check-ups will be gleaned from information on the participant's ANC/health card. | T2 (6-12 weeks after delivery) | |
Primary | 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. | T2 (6-12 weeks after delivery) | |
Primary | Birth Outcome | Birth outcomes will be self-reported and measured as stillbirth, live birth, early neonatal mortality. | T2 (6-12 weeks after delivery) | |
Primary | 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. |
T0 (Baseline at recruitment) and T2 (6 - 12 weeks postdelivery) | |
Secondary | 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. |
T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | |
Secondary | 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. | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | |
Secondary | 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. |
T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | |
Secondary | 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). | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | |
Secondary | 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). | T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum) | |
Secondary | 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) |
T0 (baseline) and T4 (11 - 14 months postpartum) | |
Secondary | 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. | T2 (6-12 postpartum) | |
Secondary | 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. | T1 (34 weeks gestation - 3 weeks postdelivery) | |
Secondary | 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. | T1 (34 weeks gestation - 3 weeks postdelivery) | |
Secondary | Newborn Weight | Newborn weight in grams; these data will be retrieved from the participant's ANC/health card and measured as newborn weight. | T2 (6-12 weeks postpartum) | |
Secondary | 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). | T2 (6 - 12 weeks postpartum) |
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