Trial · NCT04033003
Group Antenatal Care and Delivery Project
NCT04033003, Not applicable, Completed, University of Michigan; results first posted 2023-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Group Antenatal Care and Delivery Project. Trials, record NCT04033003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04033003
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Group Antenatal Care and Delivery Project
- NCT number
- NCT04033003
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,761 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Antenatal Care
- Interventions
- Group ANC
- First posted
- 2019-07-25
- Last updated
- 2024-06-07
- Results first posted
- 2023-09-28
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Ability to Identify Danger Signs in Pregnancy | 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. |
| Primary | Change in Birth Preparedness and Complication Readiness | 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. |
| Primary | Change in Ability to Identify Newborn Danger Signs | 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. |
| Primary | Attendance of ANC Visits | 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. |
| Primary | Place of Delivery | T2 (6-12 weeks after delivery) | Place of delivery will be measured using a self-report question (facility delivery, home delivery). |
| Primary | Attendance at Postpartum Check-ups for Mother | T2 (6-12 weeks after delivery) | Attendance of postpartum check-ups will be gleaned from information on the participant's ANC/health card. |
| Primary | Attendance at Postnatal Check-up for Newborn | 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. |
| Primary | Birth Outcome | T2 (6-12 weeks after delivery) | Birth outcomes will be self-reported and measured as stillbirth, live birth, early neonatal mortality. |
| Primary | Change in Health Literacy | 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. |
| Secondary | Change in Ability to Identify Postpartum Danger Signs for Mother | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Ability to Identify Danger Signs in Pregnancy | T0 Baseline (at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668 | units on a scale | MEAN |
| PRIMARY | Change in Birth Preparedness and Complication Readiness | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668 | units on a scale | MEAN |
| PRIMARY | Change in Ability to Identify Newborn Danger Signs | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668 | units on a scale | MEAN |
| PRIMARY | Attendance of ANC Visits | T2 (6-12 weeks after delivery) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Place of Delivery | T2 (6-12 weeks after delivery) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Attendance at Postpartum Check-ups for Mother | T2 (6-12 weeks after delivery) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Attendance at Postnatal Check-up for Newborn | T2 (6-12 weeks after delivery) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Birth Outcome | T2 (6-12 weeks after delivery) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Change in Health Literacy | T0 (Baseline at recruitment) and T2 (6 - 12 weeks postdelivery) | Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T2 = 585 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T2 = 596 | score on a scale | MEAN |
| SECONDARY | Change in Ability to Identify Postpartum Danger Signs for Mother | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668 | units on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Ability to Identify Danger Signs in Pregnancy | Group ANC | T0 - baseline | 1.8 | Standard Deviation 1.3 | units on a scale |
| Change in Ability to Identify Danger Signs in Pregnancy | Stand ANC | T0 - baseline | 1.7 | Standard Deviation 1.4 | units on a scale |
| Change in Ability to Identify Danger Signs in Pregnancy | Group ANC | T1 (34 weeks gestation - 3 weeks postdelivery) | 3.4 | Standard Deviation 1.6 | units on a scale |
| Change in Ability to Identify Danger Signs in Pregnancy | Stand ANC | T1 (34 weeks gestation - 3 weeks postdelivery) | 2.2 | Standard Deviation 1.3 | units on a scale |
| Change in Birth Preparedness and Complication Readiness | Group ANC | T0 | 1.4 | Standard Deviation 0.9 | units on a scale |
| Change in Birth Preparedness and Complication Readiness | Stand ANC | T0 | 1.42 | Standard Deviation 0.9 | units on a scale |
| Change in Birth Preparedness and Complication Readiness | Group ANC | T1 (34 weeks gestation - 3 weeks postdelivery) | 2.9 | Standard Deviation 1.5 | units on a scale |
| Change in Birth Preparedness and Complication Readiness | Stand ANC | T1 (34 weeks gestation - 3 weeks postdelivery) | 1.7 | Standard Deviation 1.0 | units on a scale |
| Change in Ability to Identify Newborn Danger Signs | Group ANC | T0 Baseline at recruitment | 1.9 | Standard Deviation 1.2 | units on a scale |
| Change in Ability to Identify Newborn Danger Signs | Stand ANC | T0 Baseline at recruitment | 1.5 | Standard Deviation 1.2 | units on a scale |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| T0 (Baseline at Recruitment) | STARTED | Group ANC | 877 | 7 |
| T0 (Baseline at Recruitment) | STARTED | Stand ANC | 884 | 7 |
| T0 (Baseline at Recruitment) | COMPLETED | Group ANC | 877 | 7 |
| T0 (Baseline at Recruitment) | COMPLETED | Stand ANC | 884 | 7 |
| T0 (Baseline at Recruitment) | NOT COMPLETED | Group ANC | 0 | 0 |
| T0 (Baseline at Recruitment) | NOT COMPLETED | Stand ANC | 0 | 0 |
| T1 (34 Wks Gestation - 3 Wks Postpartum) | STARTED | Group ANC | 877 | 7 |
| T1 (34 Wks Gestation - 3 Wks Postpartum) | STARTED | Stand ANC | 884 | 7 |
| T1 (34 Wks Gestation - 3 Wks Postpartum) | COMPLETED | Group ANC | 617 | 7 |
| T1 (34 Wks Gestation - 3 Wks Postpartum) | COMPLETED | Stand ANC | 668 | 7 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Death not related to study protocol | Pregnancy, puerperium and perinatal conditions | Group ANC | 2 | 877 | 2 |
| serious | Death not related to study protocol | Pregnancy, puerperium and perinatal conditions | Stand ANC | 3 | 884 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group ANC | 2 | 877 |
| Total, all-cause mortality | Stand ANC | 3 | 884 |
| Total, other adverse events | Group ANC | 0 | 877 |
| Total, other adverse events | Stand ANC | 0 | 884 |
| Total, serious adverse events | Group ANC | 2 | 877 |
| Total, serious adverse events | Stand ANC | 3 | 884 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD096277 | Group Antenatal Care to Promote a Healthy Pregnancy and Optimize Maternal and Newborn Outcomes: A Cluster Randomized Controlled Trial | LORI, JODY RAE | UNIVERSITY OF MICHIGAN AT ANN ARBOR | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2018 to 2022 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group ANC vs Stand ANC: deaths from any cause | Trial comparisons |
| Group ANC vs Stand ANC: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04033003
GET https://conductscience.org/api/trials/v1/NCT04033003/results?page=2