Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat (NCT07489664) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Indigenous Nutritional Supplements for Pregnancy to Improve Resilience in Environmental Heat
Pakistan292 participantsStarted 2026-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Women using long-lasting contraceptives such as IUDs, implants, and injectable methods like Depo-Provera.
. Women with a history of multiple miscarriage or stillbirths.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in proportion of neonates with low Weight-for-Gestational-Age Z-score (WGAZ< -2 SD) at birth between intervention and control arms.
Timeframe: Within 24 hours of delivery
2
Difference in proportion of neonates with low height-for-Gestational-Age Z-score (LGAZ< -2 SD) at birth between intervention and control arms.
. 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).
. Women having severe anemia (WHO: Severe anemia i.e., Hb \< 7g/dL).
. Women currently enrolled in BISP supplementation programs or taking any supplements other than iron and folic acid (IFA) will be excluded from the study.
. Those who do not become pregnant within three months of supplementation during pre-conception.