Improving Birth Outcomes in Bangladesh

Status Recruiting

Clinical Trial Summary

Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh. Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant. A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05855551
Study type	Interventional
Source	International Food Policy Research Institute
Contact	Jef Leroy, PhD
Phone	2028625600
Email	j.leroy@cgiar.org
Status	Recruiting
Phase	N/A
Start date	May 25, 2023
Completion date	July 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04131023` - Metabolic Tracking and Weight Gain During Pregnancy	N/A
Completed	`NCT04294095` - My Baby My Move A Community Wellness Intervention	N/A
Completed	`NCT04330976` - Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC	N/A
Completed	`NCT00530439` - Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women	N/A
Completed	`NCT04866823` - Meals for Moms: Medically-Tailored Meals for Women Who Had Gestational Diabetes	N/A
Recruiting	`NCT05576207` - BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR)	N/A
Recruiting	`NCT05807594` - Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0	N/A
Completed	`NCT03767699` - Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain
Recruiting	`NCT05119868` - Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring	N/A
Recruiting	`NCT03916354` - Maternal Gestational Weight Gain and Microbiota of Maternal and Infant
Completed	`NCT01331564` - eMOMS of Rochester	Phase 3
Completed	`NCT03957603` - Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus	N/A
Completed	`NCT03936283` - Study of a Randomized Intervention Designed to Increase Exercise in Pregnancy	N/A
Not yet recruiting	`NCT05843903` - Teen Mom 2: Improving Black Adolescent Maternal Cardiometabolic Health	N/A
Recruiting	`NCT04421053` - Weight Gain Recommendations for Chinese Women With Gestational Diabetes Mellitus
Withdrawn	`NCT04025892` - Pregnancy Tracking Pilot	N/A
Recruiting	`NCT04731688` - A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity	N/A
Active, not recruiting	`NCT04868110` - Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion	N/A
Completed	`NCT05094479` - E-health App and Lifestyle Changes During Pregnancy	N/A
Completed	`NCT05590832` - The Effect of Smart-Phone Interventional Messages on Gestational Weight Gain	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.