- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01832688
Assessment of the Nutritional Status of Pregnant Women and Optimization of Prenatal Care Services
February 26, 2020 updated by: University of California, Davis
Assessment of the Nutritional Status of Pregnant Women in Zinder, Niger and Optimization of Prenatal Care Services
A national survey in Niger found that women and children are at risk of undernutrition and that many pregnant women don't visit health centers during pregnancy as often as is recommended.
The aim is to assess the nutritional and health status of pregnant women in the Zinder region and to understand their knowledge, attitudes and practices related to health and nutrition during pregnancy.
In collaboration with the Medical District of Zinder the prenatal care services will be optimized and the programmatic impact on gestational weight gain and anemia prevalence will be assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2306
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zinder, Niger
- Helen Keller International
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant women residing in participating villages
Description
Inclusion Criteria:
- Pregnant
Exclusion Criteria:
- Pregnant women, who have severe illness warranting immediate hospital referral
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Baseline cohort
The baseline survey will be implemented among pregnant women in randomly selected villages using a continuous enrollment schedule over the period of 18 months
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Optimization cohort
The programmatic impact of optimized prenatal care services on women's health and behavior will be assessed among pregnant women in randomly selected villages (Programmatic prenatal care optimization)
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To further integrate and improve nutrition-related services and messages in the prenatal care package.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Prevalence of inadequate gestational weight gain
Time Frame: 6 months
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6 months
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Anemia prevalence
Time Frame: 6 months
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6 months
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Access and adherence to prenatal iron and folic acid supplements
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Prevalence of inadequate dietary diversity scores
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hess SY, Ouedraogo CT, Bamba IF, Wessells KR, Keith N, Faye T, Ndiaye B, Doudou M, Nielsen J. Using formative research to promote antenatal care attendance and iron folic acid supplementation in Zinder, Niger. Matern Child Nutr. 2018 Apr;14(2):e12525. doi: 10.1111/mcn.12525. Epub 2017 Sep 19.
- Wessells KR, Young RR, Ferguson EL, Ouedraogo CT, Faye MT, Hess SY. Assessment of Dietary Intake and Nutrient Gaps, and Development of Food-Based Recommendations, among Pregnant and Lactating Women in Zinder, Niger: An Optifood Linear Programming Analysis. Nutrients. 2019 Jan 2;11(1):72. doi: 10.3390/nu11010072.
- Wessells KR, Ouedraogo CT, Young RR, Faye MT, Brito A, Hess SY. Micronutrient Status among Pregnant Women in Zinder, Niger and Risk Factors Associated with Deficiency. Nutrients. 2017 Apr 26;9(5):430. doi: 10.3390/nu9050430.
- Begum K, Ouedraogo CT, Wessells KR, Young RR, Faye MT, Wuehler SE, Hess SY. Prevalence of and factors associated with antenatal care seeking and adherence to recommended iron-folic acid supplementation among pregnant women in Zinder, Niger. Matern Child Nutr. 2018 Feb;14 Suppl 1(Suppl 1):e12466. doi: 10.1111/mcn.12466.
- Hess SY, Ouedraogo CT, Young RR, Bamba IF, Stinca S, Zimmermann MB, Wessells KR. Urinary iodine concentration identifies pregnant women as iodine deficient yet school-aged children as iodine sufficient in rural Niger. Public Health Nutr. 2017 May;20(7):1154-1161. doi: 10.1017/S1368980016003232. Epub 2016 Dec 15.
- Ouedraogo CT, Wessells KR, Young RR, Bamba IF, Faye MT, Banda N, Hess SY. The mixed effects of a package of multilevel interventions on the health and care of pregnant women in Zinder, Niger. BMJ Glob Health. 2019 Dec 10;4(6):e001200. doi: 10.1136/bmjgh-2018-001200. eCollection 2019.
- Ouedraogo CT, Wessells KR, Young RR, Faye MT, Hess SY. Prevalence and determinants of gestational weight gain among pregnant women in Niger. Matern Child Nutr. 2020 Jan;16(1):e12887. doi: 10.1111/mcn.12887. Epub 2019 Sep 30.
- Ouedraogo CT, Vosti SA, Wessells KR, Arnold CD, Faye MT, Hess SY. Out-of-pocket costs and time spent attending antenatal care services: a case study of pregnant women in selected rural communities in Zinder, Niger. BMC Health Serv Res. 2021 Jan 8;21(1):47. doi: 10.1186/s12913-020-06027-2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
April 4, 2013
First Submitted That Met QC Criteria
April 11, 2013
First Posted (Estimate)
April 16, 2013
Study Record Updates
Last Update Posted (Actual)
February 28, 2020
Last Update Submitted That Met QC Criteria
February 26, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 447971
- 10-1335-UCALIF (Other Grant/Funding Number: The Micronutrient Initiative)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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