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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, Davis
Sponsor:
Collaborators:
Helen Keller International
Micronutrient Initiative
UNICEF
Information provided by (Responsible Party):
Sonja Hess, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01832688
First received: April 4, 2013
Last updated: June 13, 2014
Last verified: June 2014
  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


Estimated Enrollment: 2305
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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

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

Contacts
Contact: Thierno Faye +227 20 75 33 14 tfaye@hki.org
Contact: Cesaire T Ouedraogo, MD +227 20 51 09 39 ctouedraogo@ucdavis.edu

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

No publications provided

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: June 13, 2014
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 November 24, 2014