Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAga Khan University
About this trial
The purpose of this study is to learn whether a simple, traditional, and balanced meal made from local foods, eaten once a day during pregnancy, can help women in rural Pakistan stay healthier in hot weather and give birth to healthier babies. Climate change has made heat a serious challenge for pregnant women, especially in areas with limited resources. This study will explore whether an indigenous meal that is culturally acceptable and easy to prepare can improve resilience to heat stress and support better outcomes for both mothers and newborns.
The study will focus on two main questions:
* Can this daily balanced meal reduce the harmful effects of heat stress during pregnancy? * Does it improve newborn health, especially birth weight?
Researchers will compare women who eat the balanced local meal every day with women who continue their usual meals. They will check changes in women's health, levels of key vitamins and nutrients, and their babies' birth outcomes.
During the study, participants will:
* Either eat the balanced local meal daily or continue their usual meals. * Share information on their health, diet, and heat exposure. * Provide small samples, such as blood and stool, to study nutrient levels and gut health. * Have their newborns' health and growth measured at birth.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 18-45 years belonging to a low to middle socioeconomic status, residing in Mithi, Districts in Sindh.
Planning to conceive within the study time frame and expect to become pregnant within four months of starting nutritional intervention.
Women who confirm their pregnancy during the first trimester i.e., before 8 weeks of gestational age.
Disqualifiers
Women using long-lasting contraceptives such as IUDs, implants, and injectable methods like Depo-Provera.
Women with a history of multiple miscarriage or stillbirths.
Women with known chronic diseases, such as cardiovascular disorders, hepatic disorders, renal disorders, and infectious diseases.
Women suffering from severe malnutrition (WHO: Underweight i.e., having BMI < 16 Kg/m2 or obese having BMI ≥ 30 Kg/m2).
Trial design
Design model
Parallel
Treatments tested in this trial
Indigenous Balanced Diet Arm
Dietary supplementThe uniqueness of this intervention lies in its culturally-preservative approach, its novel target of heat stress, its timing (preconception), and its integrated process (nutritionist collaboration + overall dietary counseling). It specifically targets heat resilience in pregnancy through a holistic approach of adapting dietary intervention as mitigating strategy for providing resilience to heat stress and evaluating key hypothesized pathways responsible for combating adverse pregnancy outcomes by this intervention.
Treatment groups
292 Participants
are divided into 2 treatment groupsGroup A: Indigenous Balanced Diet ArmOther 1 intervention
Group B: Usual Diet ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Difference in proportion of neonates with low Weight-for-Gestational-Age Z-score (WGAZ< -2 SD) at birth between intervention and control arms.
Neonatal birth weight (grams) will be measured using a digital infant weighing scale within 24 hours of birth. Birth weight will be converted into WGAZ using WHO 2013 sex- and gestational age-specific reference standards. The percentage of neonates with low WGAZ (\< -2 SD) will be calculated for both supplemented and non-supplemented groups, and comparisons between groups will be made using appropriate statistical methods, adjusting for maternal heat stress exposure. Unit of Measure: % of neonates with WGAZ \< -2 SD
Time frame
Within 24 hours of delivery2
Difference in proportion of neonates with low height-for-Gestational-Age Z-score (LGAZ< -2 SD) at birth between intervention and control arms.
Neonatal birth height (cm) will be measured using a standardized neonate's height scale within 24 hours of birth. Birth height will be converted into LGAZ using WHO 2013 sex- and gestational age-specific reference standards. The percentage of neonates with low LGAZ (\< -2 SD) will be calculated for both supplemented and non-supplemented groups, and comparisons between groups will be made using appropriate statistical methods, adjusting for maternal heat stress exposure. Unit of Measure: % of neonates with LGAZ \< -2 SD
Time frame
Within 24 hours of deliverySecondary outcomes
1
Gestational age at delivery
Gestational age will be determined based on first-trimester ultrasound and/or last menstrual period (LMP). Unit of Measure: Weeks
Time frame
At delivery date2
Mode of delivery
Mode of delivery will be recorded as vaginal or cesarean section. Unit of Measure: Percentage (%) of cesarean deliveries
Time frame
At delivery3
Maternal serum ferritin concentration
Maternal serum ferritin will be measured using standardized immunoturbidimetric assay on an automated chemistry analyzer. Unit of Measure: ng/mL
Time frame
Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.4
Maternal serum folate concentration
Maternal serum folate will be measured using standardized laboratory assay on automated immunoassay analyzer.
Time frame
Evaluated at the end of each trimester (within one week before or after the scheduled time point), from enrollment until delivery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aga Khan University
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
Source ClinicalTrials.gov
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