Trial · NCT04033003
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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. |
| Secondary | Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | 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. |
| Secondary | Change in Knowledge of Family Planning Methods | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | 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. |
| Secondary | Change in Intent to Use Family Planning | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | 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). |
| Secondary | Change in Uptake of Family Planning | T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum) | 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). |
| Secondary | Change in Interpersonal Violence | T0 (baseline) and T4 (11 - 14 months postpartum) | 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) |
| Secondary | Experience of ANC Care | T2 (6-12 postpartum) | 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. |
| Secondary | Completion of IPTp2 Malaria Prophylaxis During Pregnancy | T1 (34 weeks gestation - 3 weeks postdelivery) | Data gleaned from the participant's ANC/health record will be used to measure affirmative completion of IPTp2 malaria prophylaxis during pregnancy. |
| Secondary | Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy | T1 (34 weeks gestation - 3 weeks postdelivery) | 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. |
| Secondary | Newborn Weight | T2 (6-12 weeks postpartum) | Newborn weight in grams; these data will be retrieved from the participant's ANC/health card and measured as newborn weight. |
| Secondary | Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). | T2 (6 - 12 weeks postpartum) | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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