NCT01832688

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,306

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

April 4, 2013

Last Update Submit

February 26, 2020

Conditions

Keywords

iron and folic acid supplementsanemiagestational weight gain

Outcome Measures

Primary Outcomes (3)

  • Prevalence of inadequate gestational weight gain

    6 months

  • Anemia prevalence

    6 months

  • Access and adherence to prenatal iron and folic acid supplements

    6 months

Secondary Outcomes (1)

  • Prevalence of inadequate dietary diversity scores

    6 months

Study Arms (2)

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

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)

Other: Programmatic prenatal care optimization

Interventions

To further integrate and improve nutrition-related services and messages in the prenatal care package.

Optimization cohort

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women residing in participating villages

You may qualify if:

  • Pregnant

You may not qualify if:

  • Pregnant women, who have severe illness warranting immediate hospital referral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen Keller International

Zinder, Niger

Location

Related Publications (8)

  • 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.

    PMID: 28924978BACKGROUND
  • 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.

    PMID: 30609695BACKGROUND
  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine sample for assessment of nutritional status

MeSH Terms

Conditions

AnemiaGestational Weight Gain

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesWeight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sonja Y Hess, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 16, 2013

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations