Women First: Preconception Maternal Nutrition

Women First: Preconception Maternal Nutrition

Sponsors

Lead Sponsor: University of Colorado, Denver

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Instituto de Nutricion de Centroamerica y Panama (INCAP)
Kinshasa School of Public Health
Jawaharlal Nehru Medical College
Aga Khan University
RTI International

Source University of Colorado, Denver
Brief Summary

Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.

Detailed Description

The objective is to determine the benefits to the offspring of women in poor, food-insecure environments of commencing a daily comprehensive maternal nutrition supplement (with additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior to conception versus the benefits of commencing the same supplement at 12 weeks gestation and also to compare offspring outcomes with those of a control group which receives no supplement.

Overall Status Active, not recruiting
Start Date August 2013
Completion Date October 30, 2020
Primary Completion Date October 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Neonatal linear growth <24 hours of age
Secondary Outcome
Measure Time Frame
Length-for-age Z-scores age 0.5, 1, 3, 6, 12, 18 and 24 months postnatal
Estimate fetal growth 12 weeks gestation
Mean birth weight at birth
Incidence of low birth weight (LBW) infants at birth
Perinatal Mortality From 20 weeks gestation through 1 month of age
Incidence of severe neonatal and infant infectious disease birth to 6 months of age
Epigenome (Maternal) baseline, 12 and 34 weeks gestation, delivery, and 3 months postpartum (maternal); 2 weeks and 3 months of age (infant)
Epigenome (Infant) 2 weeks and 3 months of age
Deep phenotyping of maternal metabolic and nutritional status 12 and 34 weeks gestation, delivery, and 3 months postpartum
Microbiome (maternal) 12 & 34 weeks gestation and delivery (maternal)
Microbiome (infant) 14 days and 3 months of age (infant)
Composition of breast milk 14 days postpartum
Neurodevelopment assessment 24 mo age
Enrollment 7374
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Comprehensive Maternal Nutrition Intervention

Description: The nutrition intervention will be delivered before conception or at 12 weeks gestation and continued through delivery and compared with a control group. The supplement to be used is a multi-micronutrient (MMN) fortified lipid-based supplement composed of dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers.

Eligibility

Criteria:

Inclusion Criteria:

- 16-35 years of age;

- expectation to have first or further pregnancy without intent to utilize contraception

- Hb >8 g/dL

Exclusion Criteria:

- Nulliparous women who do not agree to hospital delivery (equipped for caesarian section) or/and do not have ready access to such a facility.

Gender: Female

Minimum Age: 16 Years

Maximum Age: 35 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility:
Kinshasa School of Public Health | Kinshasa, Congo, The Democratic Republic of the
INCAP | Guatemala City, Guatemala
Jawaharlal Nehru Medical College | Belgaum, 590 010, India
Aga Khan University | Karachi, Pakistan
Location Countries

Congo, The Democratic Republic of the

Guatemala

India

Pakistan

Verification Date

November 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Arm 1: Preconception

Type: Experimental

Description: Arm 1 will commence the comprehensive maternal nutrition intervention at 3-7 months postpartum. Delivery of the intervention will be monitored biweekly by collection of empty and unused sachets of the lipid-based supplement (LNS), maternal report, and casual observation of household behavior. Arm 1 participants will be weighed monthly and Body Mass Index (BMI) calculated. If BMI <20 an additional energy supplement will be provided. Menstrual history will be obtained at each visit and a urine pregnancy test will be performed if menses is delayed.

Label: Arm 2: Pregnancy

Type: Experimental

Description: Participants in Arm 2 will commence the same comprehensive maternal nutrition intervention at 12 weeks gestation.

Label: Arm 3: Control

Type: No Intervention

Description: Participants in Arm 3 will receive biweekly visits to monitor pregnancy status. No health advice will be given other than information about prenatal care, location of delivery, and breastfeeding education in the third trimester.

Acronym WF
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov