Assessment of the Nutritional Status of Pregnant Women and Optimization of Prenatal Care Services

This study has been completed.
Sponsor:
Collaborators:
Helen Keller International
Micronutrient Initiative
Information provided by (Responsible Party):
Sonja Hess, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01832688
First received: April 4, 2013
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Pregnancy
Other: Programmatic prenatal care optimization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Nutritional Status of Pregnant Women in Zinder, Niger and Optimization of Prenatal Care Services

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Prevalence of inadequate gestational weight gain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Anemia prevalence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Access and adherence to prenatal iron and folic acid supplements [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of inadequate dietary diversity scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Blood and urine sample for assessment of nutritional status

Enrollment: 2306
Study Start Date: February 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: Programmatic prenatal care optimization
To further integrate and improve nutrition-related services and messages in the prenatal care package.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women residing in participating villages
Criteria

Inclusion Criteria:

  • Pregnant

Exclusion Criteria:

  • Pregnant women, who have severe illness warranting immediate hospital referral
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832688

Locations
Niger
Helen Keller International
Zinder, Niger
Sponsors and Collaborators
University of California, Davis
Helen Keller International
Micronutrient Initiative
Investigators
Principal Investigator: Sonja Y Hess, PhD University of California, Davis
  More Information

Responsible Party: Sonja Hess, Associate Research Nutritionist, University of California, Davis
ClinicalTrials.gov Identifier: NCT01832688     History of Changes
Other Study ID Numbers: 201300662  10-1335-UCALIF 
Study First Received: April 4, 2013
Last Updated: November 30, 2015
Health Authority: Niger: Comité Consultatif National d'Ethique

Keywords provided by University of California, Davis:
iron and folic acid supplements
anemia
gestational weight gain

ClinicalTrials.gov processed this record on July 25, 2016