PregnancyNCT01832688
Assessment of the Nutritional Status of Pregnant Women and Optimization of Prenatal Care Services
An observational study of Pregnancy, run by University of California, Davis at 1 site in Niger.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Programmatic prenatal care optimization
- How many people
- 2,306 participants
- Where
- 1 siteNiger
- Study dates
- Feb 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women residing in participating villages
Who may be able to join
- Pregnant
Who cannot join
- Pregnant women, who have severe illness warranting immediate hospital referral
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Nutritional Status of Pregnant Women in Zinder, Niger and Optimization of Prenatal Care Services
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.
- Conditions
- Pregnancy
- Being tested
- Programmatic prenatal care optimization
- Keywords
- iron and folic acid supplements, anemia, gestational weight gain
- Medical subject headings
- Anemia, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmatic prenatal care optimizationOther
To further integrate and improve nutrition-related services and messages in the prenatal care package.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Programmatic prenatal care optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of inadequate gestational weight gain
Measured: 6 months
Anemia prevalence
Measured: 6 months
Access and adherence to prenatal iron and folic acid supplements
Measured: 6 months
Secondary outcomes (1)
Prevalence of inadequate dietary diversity scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Keller International, Micronutrient Initiative
- Responsible party
- Sponsor
- Investigators
- Sonja Y Hess, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832688
- Sponsor's protocol ID
- 447971
- Other IDs
- 10-1335-UCALIF
- Status last verified
- Feb 2020
- First submitted
- 4 Apr 2013
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
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 28924978Wessells 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 30609695Wessells 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 28445440Begum 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 29493896Hess 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 27974077Ouedraogo 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 31908852Ouedraogo 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 31568674Ouedraogo 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Nutritional Status of Pregnant Women in Zinder, Niger and Optimization of Prenatal Care Services
- ClinicalTrials.gov ID
- NCT01832688
- Acronym / sponsor ID
- 447971
- Conditions
- Pregnancy
- Keywords
- iron and folic acid supplements, anemia, gestational weight gain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,306 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Helen Keller International, Micronutrient Initiative
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Programmatic prenatal care optimizationThe 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) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women residing in participating villages
Key inclusion criteria (1 listed)
- Pregnant
Key exclusion criteria (1 listed)
- Pregnant women, who have severe illness warranting immediate hospital referral
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programmatic prenatal care optimizationTo further integrate and improve nutrition-related services and messages in the prenatal care package. | Other | Optimization cohort |
Primary outcome
Prevalence of inadequate gestational weight gain
Time frame: 6 months
Anemia prevalence
Time frame: 6 months
Access and adherence to prenatal iron and folic acid supplements
Time frame: 6 months
1 secondary outcome
Prevalence of inadequate dietary diversity scores
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Background: PubMed 28924978Hess 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.
- Background: PubMed 30609695Wessells 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.
- Results publication: PubMed 28445440Wessells 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.
- Results publication: PubMed 29493896Begum 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.
- Results publication: PubMed 27974077Hess 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.
- Results publication: PubMed 31908852Ouedraogo 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.
- Results publication: PubMed 31568674Ouedraogo 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.
- Derived from this study: PubMed 33419448Ouedraogo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonja Y Hess, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of California, Davis at 1 site in Niger.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Niger. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of inadequate gestational weight gain (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832688, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.