Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial (MumtaPW)
Undernutrition
About this trial
This is an interventional treatment trial for Undernutrition
Eligibility Criteria
Inclusion Criteria:
- Gestational age between ≥8 and < 19 weeks confirmed by ultrasound
- Able to give written voluntary informed consent.
- Permanent resident within the surveillance area, i.e. woman should be resident of the area for last 6 months at least to be considered as part of surveillance.
- Willing to spend the whole pregnancy duration after registration in trial within surveillance area until the birth outcome.
- Singleton and viable fetus on ultrasound
- Not working woman, and available for ANC and compliance visits at home.
- Previously not enrolled in pregnant woman trial.
- Previously not enrolled in Lactating woman trials.
Exclusion Criteria:
- Having Mid-upper-arm-circumference of pregnant of ≥30.5 cm
- Having known food allergies if reported by woman (like peanut, lentils)
Sites / Locations
- Peri-urban slum (Rehri Goth)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
Control Arm
Nutrition only Arm
Nutrition plus Azithromycin Arm
Nutrition plus Choline and Nicotinamide Arm
Arm-A: Standard antenatal care (ANC) counseling, service provision and nutrition counseling (World Health Organization (WHO) standard)
Arm-B:Balanced-energy protein (BEP), ready-to-use utrition supplement for at least 6 months + Standard ANC counseling, service provision and nutrition counseling (WHO standard)
Arm-C:Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + 2000 mg of Azithromycin at week 20 and 28 of pregnancy + Standard ANC counseling, service provision and nutrition counseling (WHO standard).
Arm-D: Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + Choline 450 and Nicotinamide 100 mg (1 each once daily orally starting from week 20 until birth outcome) + Standard ANC counseling, service provision and nutrition counseling (WHO standard).