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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01832688
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : February 28, 2020
Sponsor:
Collaborators:
Helen Keller International
Micronutrient Initiative
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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.

Condition or disease Intervention/treatment
Pregnancy Other: Programmatic prenatal care optimization

Study Design
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Study Type : Observational
Actual Enrollment : 2306 participants
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
Study Start Date : February 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
To further integrate and improve nutrition-related services and messages in the prenatal care package.


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of inadequate gestational weight gain [ Time Frame: 6 months ]
  2. Anemia prevalence [ Time Frame: 6 months ]
  3. Access and adherence to prenatal iron and folic acid supplements [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Prevalence of inadequate dietary diversity scores [ Time Frame: 6 months ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832688


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

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01832688    
Other Study ID Numbers: 447971
10-1335-UCALIF ( Other Grant/Funding Number: The Micronutrient Initiative )
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Keywords provided by University of California, Davis:
iron and folic acid supplements
anemia
gestational weight gain