ClinicalTrials.gg
CompletedNCT01832688Updated Feb 28, 2020

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

An observational study in Pregnancy, sponsored by University of California, Davis. Completed at 1 site in Niger. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by University of California, Davis · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,306
Sex
Female
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Study 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.

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Conditions studied

  • Pregnancy

Keywords

  • iron and folic acid supplements
  • anemia
  • gestational weight gain
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In context

Anemia

1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.

This study's enrollment of 2,306 is above the median of 270 across 368 observational studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant women residing in participating villages

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,306 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherProgrammatic prenatal care optimization

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

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What researchers measure

Primary outcomes

  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 outcomes

  1. Prevalence of inadequate dietary diversity scores

    Time frame: 6 months

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Study locations

1 site
  • Helen Keller International
    Zinder, Niger
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References and documents

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. PubMed 28924978 ↗
  • 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. PubMed 30609695 ↗
  • 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. PubMed 28445440 ↗
  • 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. PubMed 29493896 ↗
  • 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. PubMed 27974077 ↗
  • 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. PubMed 31908852 ↗
  • 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. PubMed 31568674 ↗
  • 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. PubMed 33419448 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2014, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2013
First posted
Apr 16, 2013
Start
Feb 2014
Primary completionActual
Sep 2015
CompletionActual
Sep 2015
Last update
Feb 28, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01832688
Collaborators
Helen Keller International, Micronutrient Initiative
Responsible party
Sponsor
First posted
Apr 16, 2013
Start date
Feb 2014
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Feb 28, 2020

Study contacts

Sonja Y Hess, PhD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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