Women First: Preconception Maternal Nutrition (WF)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Mortality; Growth Failure; Maternal Malnutrition; Stunting; Morbidity

Treatments: Dietary Supplement: Comprehensive Maternal Nutrition Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01883193

U10HD076474-01 (U.S. NIH Grant/Contract)

12-1672

OPP1055867 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,374 patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,374 participants in 3 patient groups

Arm 1: Preconception

Experimental group

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.

Treatment:

Dietary Supplement: Comprehensive Maternal Nutrition Intervention

Arm 2: Pregnancy

Experimental group

Description:

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

Treatment:

Dietary Supplement: Comprehensive Maternal Nutrition Intervention

Arm 3: Control

No Intervention group

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.