Effectiveness of LNS and MNP Supplements to Prevent Malnutrition in Women and Their Children in Bangladesh (RDNS)

May 24, 2017 updated by: University of California, Davis

Home-fortification Approaches for the Prevention of Malnutrition in Pregnant and Lactating Women and Their Children in Bangladesh: Program Effectiveness Study

The program effectiveness study aims to assess the effect of a lipid-based nutrition supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for improving maternal nutritional status during pregnancy and lactation (LNS only), and preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.

Study Overview

Detailed Description

This study is a cluster-randomized controlled trial with four study "arms", implemented within the context of the Community Health and Development Program (CHDP) run by the World Mission Prayer League, which also has a hospital in the area and is known as LAMB. Data collection is longitudinal, starting with the identification of women in early pregnancy who are eligible to enter the study, and continuing, with follow-up of the child, until 24 months post-partum. A final follow-up visit will occur when the child is 36 months old to update contact information; no outcomes data will be collected at that final visit. The investigators are evaluating the effect of providing LNS-PLW to mothers during pregnancy and lactation on maternal health and nutrition outcomes (including anthropometric and micronutrient status), morbidity and birth outcomes in comparison to mothers who receive iron-folic acid tablets during pregnancy and lactation. The investigators are also evaluating the effect of three different home-fortification approaches (arms a-c, below) on child health and nutrition outcomes including anthropometric status, micronutrient status, anemia, and motor and cognitive development, in comparison to a control arm not receiving a home fortification intervention.

Additionally, the cost of implementation and delivery of the LNS-PLW, LNS-child or MNP interventions as part of the CHDP compared to standard CHDP program delivery will be documented. Willingness to pay (private demand) for LNS-PLW, LNS-child and MNP products by selected caregivers and male heads of households will be assessed at baseline and again at various points during the intervention period.

A process evaluation of the LNS and MNP interventions, and of the services provided to the control group, within the CHDP will be conducted to: 1) Document and evaluate the processes needed for implementation of interventions that provide a nutrient supplement such as LNS or MNP in the context of the CHDP; and 2) Explain and interpret program effectiveness study results and identify important facilitators and barriers to success of the nutrition intervention, which can be used to improve the effectiveness of current CHDP programs and future similar programs that include the scaling-up of LNS or MNP.

A post-intervention follow-up assessment for participants in the RDNS trial was added to the study protocol in November 2015. The intervention stopped when the study children turned 24 months old, and follow-up visits to update contact information were conducted when the children turned 36 months old. Thereafter, when the study children are between 40 and 52 months old, the follow-up assessment includes anthropometric and cognitive development assessments and collection of blood samples (finger prick, for measurement of hemoglobin) and buccal swab samples at the local clinics; for the mothers the follow-up includes anthropometric measurements, measurement of blood pressure and collection of fasting blood samples (finger prick). The follow-up also includes anthropometric measurements of the younger siblings, as well as a home visit to collect information on socioeconomic status, food security, hospitalizations of mother or child, developmental stimulation in the home, child food preferences and retrospective perceptions about the trial interventions.

Follow-up outcomes:

Maternal: Body mass index, skinfold thickness, mid-upper arm circumference, attained height. Hemoglobin, anemia, blood pressure, blood lipids, HbA1C.

Index child: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, skinfold thickness, MUAC, arm fat and muscle area. Verbal ability (language), non-verbal ability (visual spatial), executive function and pre-academic skills. Hemoglobin, anemia. Hospitalizations since 24 months of age. Preferences for sweet and fatty foods.

Younger sibling: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, MUAC.

Study Type

Interventional

Enrollment (Actual)

4011

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rangpur and Dinajpur Districts
      • Parbatipur, Rangpur and Dinajpur Districts, Bangladesh
        • LAMB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestational age ≤ 20 weeks
  • Planning to remain in the study area during pregnancy and the following three years (i.e., a permanent resident of the study area)

Exclusion Criteria:

  • Pregnancy identified and registered in the CHDP program before the beginning of the enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive
"Comprehensive" LNS: LNS-PLW provided daily to mothers during pregnancy and postpartum lactation (a total of at least 11 months, starting by 20 weeks gestation and ending at 6 months post-partum) and LNS developed for infants and young children (LNS-child) provided daily to their infants (beginning at 6 months of age for a period of 18 months i.e., from 6-24 months of age).

Dietary supplement: Lipid-based nutrient supplement

Lipid-based nutrient supplement for pregnant and lactating women (LNS-PLW)

Daily dose of LNS-PLW will be 20 g, packaged in one sachet

Dietary supplement: Lipid-based nutrient supplement

Lipid-based nutrient supplement for infants and young children (LNS-Child)

Daily dose of LNS-Child will be 20 g, packaged in two 10 g sachets

Experimental: Child-only LNS
"Child-only" LNS: Daily LNS-child supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.

Dietary supplement: Lipid-based nutrient supplement

Lipid-based nutrient supplement for infants and young children (LNS-Child)

Daily dose of LNS-Child will be 20 g, packaged in two 10 g sachets

Dietary supplement: Iron and folic acid nutrient supplement

Iron-folic acid tablets for pregnant and lactating women

Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid

Experimental: Child-only MNP
"Child-only" MNP: Daily MNP supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.

Dietary supplement: Iron and folic acid nutrient supplement

Iron-folic acid tablets for pregnant and lactating women

Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid

Dietary supplement: Micronutrient powder

Micronutrient powder for infants and young children (MNP)

The MNP for children will be packaged in 1 g sachets, so that each day, the child will consume one sachet.

Active Comparator: Control: IFA
Control: No additional nutrient supplementation for the child will be provided through the study, but the regular nutrition education and visits provided by the program frontline staff will continue. Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.

Dietary supplement: Iron and folic acid nutrient supplement

Iron-folic acid tablets for pregnant and lactating women

Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth weight
Time Frame: Within 48 hours (or back calculated from later measurements).
Birth weight of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Within 48 hours (or back calculated from later measurements).
Birth length
Time Frame: Within 48 hours (or back calculated from later measurements)
Birth length of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Within 48 hours (or back calculated from later measurements)
Child linear growth status at 24 months
Time Frame: 24 months
Linear growth (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maternal weight between baseline and 36 wk gestation
Time Frame: Between 12-20 and 36 weeks of gestation
Gestational weight gain from enrollment (by 20 weeks of gestation) through 36 weeks of gestation (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 12-20 and 36 weeks of gestation
Pre-eclampsia
Time Frame: 36 weeks of gestation
Prevalence of pre-eclampsia (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
36 weeks of gestation
Duration of gestation
Time Frame: Day 0
Duration of gestation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Day 0
Pre-term delivery
Time Frame: Day 0
Prevalence of pre-term delivery (delivery at <37 gestational weeks) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Day 0
Low birth weight
Time Frame: Within 48 hours (or back calculated from later measurements)
Prevalence of low birth weight (birth weight < 2500 g) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Within 48 hours (or back calculated from later measurements)
Small for gestational age (SGA)
Time Frame: Within 48 hours (or back calculated from later measurements)
Prevalence of SGA (birth weight < 10th percentile) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Within 48 hours (or back calculated from later measurements)
Newborn stunting
Time Frame: Within 48 hours (or back calculated from later measurements)
Prevalence of newborn stunting (length-for-age z-score <-2) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Within 48 hours (or back calculated from later measurements)
BMI z score at birth
Time Frame: Within 48 hours (or back calculated from later measurements)
BMI z score at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Within 48 hours (or back calculated from later measurements)
Head circumference (HC) at birth
Time Frame: Within 48 hours (or back calculated from later measurements)
Head circumference at birth of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Within 48 hours (or back calculated from later measurements)
Small head size at birth
Time Frame: Within 48 hours (or back calculated from later measurements)
Prevalence of small head size (HC-z-score <-2) at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Within 48 hours (or back calculated from later measurements)
Change in maternal weight between 42 d and 6 mo postpartum
Time Frame: Between 42 d and 6 mo postpartum
Postpartum weight change from 42 days through 6 mo postpartum (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), for time of year when outcome was assessed
Between 42 d and 6 mo postpartum
Change in maternal iodine status between baseline and 6 mo postpartum
Time Frame: Between 10-20 weeks of gestation and 6 months postpartum
Prevalence of iodine deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iodine status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal iron status between baseline and 6 months postpartum
Time Frame: Between 10-20 weeks of gestation and 6 months postpartum
Prevalence of iron deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal iron-deficiency anemia between baseline and 6 months postpartum
Time Frame: Between 10-20 weeks of gestation and 6 months postpartum
Prevalence of iron-deficiency anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal anemia between baseline and 6 months postpartum
Time Frame: Between 10-20 weeks of gestation and 6 months postpartum
Prevalence of anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal vitamin A status between baseline and 6 months postpartum
Time Frame: Between 10-20 weeks of gestation and 6 months postpartum
Prevalence of vitamin A deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal vitamin A status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 10-20 weeks of gestation and 6 months postpartum
Change in maternal depressive symptoms between baseline and 6 months postpartum
Time Frame: Between 10-20 weeks of gestation and 6 months postpartum
Prevalence of depression during lactation (women who received LNS-PLW vs. a comparison group). Pre-defined tests for interaction will be done for: baseline maternal depression status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 10-20 weeks of gestation and 6 months postpartum
Child hemoglobin concentration at 18 months of age
Time Frame: 18 months
Hemoglobin concentration (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
18 months
Child iron status at 18 months of age
Time Frame: 18 months
Prevalence of iron deficiency (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
18 months
Child vitamin A status at 18 months of age
Time Frame: 18 months
Prevalence of vitamin A deficiency (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
18 months
Child anemia status at 18 months of age
Time Frame: 18 months
Prevalence of anemia in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
18 months
Child iron-deficiency anemia status at 18 months of age
Time Frame: 18 months
Prevalence of iron-deficiency anemia in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
18 months
Wasting at 24 months of age
Time Frame: 24 months
Prevalence of wasting (weight-for-length z-score <-2) in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
24 months
Head circumference at 24 months of age
Time Frame: 24 months
Head circumference of children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
24 months
Stunting at 24 months of age
Time Frame: 24 months
Prevalence of stunting (length-for-age z-score <-2) in children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
24 months
Child motor development at 24 months of age
Time Frame: 24 months
Motor development of children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
24 months
Child cognitive development at 24 months of age
Time Frame: 24 months
Cognitive development of children (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maternal hemoglobin concentration between baseline and 36 wk gestation
Time Frame: Between 12-20 weeks and 36 weeks of gestation
Hemoglobin concentration during pregnancy (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: hemoglobin baseline value, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 12-20 weeks and 36 weeks of gestation
Change in maternal iodine status between baseline and 36 wk gestation
Time Frame: Between 12-20 weeks and 36 weeks of gestation
Prevalence of iodine deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iodine status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 12-20 weeks and 36 weeks of gestation
Change in maternal depressive symptoms between baseline and 36 wk gestation
Time Frame: Between 12-20 weeks and 36 weeks of gestation
Prevalence of depression during pregnancy (women who received LNS-PLW vs. a comparison group). Pre-defined tests for interaction will be done for: baseline maternal depression status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 12-20 weeks and 36 weeks of gestation
Change in maternal iron status between baseline and 36 wk gestation
Time Frame: Between 12-20 weeks and 36 weeks of gestation
Prevalence of iron deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 12-20 weeks and 36 weeks of gestation
Change in maternal vitamin A status between baseline and 36 wk gestation
Time Frame: Between 12-20 weeks and 36 weeks of gestation
Prevalence of vitamin A deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal vitamin A status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 12-20 weeks and 36 weeks of gestation
Change in maternal anemia between baseline and 36 wk gestation
Time Frame: Between 12-20 weeks and 36 weeks of gestation
Prevalence of anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 12-20 weeks and 36 weeks of gestation
Change in maternal iron-deficiency anemia between baseline and 36 wk gestation
Time Frame: Between 12-20 weeks and 36 weeks of gestation
Prevalence of iron-deficiency anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron-deficiency anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Between 12-20 weeks and 36 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 252233
  • PR-10044 (Other Identifier: ICDDR,B)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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