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New treatment option for Newborn Health
Official title The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes
ClinicalTrials.gov ID: NCT07029282
What this study is testing
What is MMS Plus?
MMS Plus is an investigational medicine, given as an once-weekly, being studied as a potential treatment for newborn health.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial aims to learn if MMS Plus improves infant health compared to standard MMS during pregnancy and the postnatal period in women living in peri-urban areas of Karachi, Pakistan. It will also evaluate how MMS Plus affects infant growth during the first 6 months of life.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 49, women only. Healthy volunteers may be eligible.
You may be able to join if
- Antenatal Phase::
- Gestational age confirmed by ultrasound to be 8-14 weeks
- Singleton and viable fetus on ultrasound
- A resident of the catchment area for at least the last six months
- Plans to stay within the catchment area during the pregnancy duration, during delivery and after birth of the baby.
You likely can't join if
- Women with known allergies or intolerance to any components of the MMS or MMS PLUS being studied
- Women with pre-existing health conditions such as history of uncontrolled diabetes and hypertension or other chronic illnesses
- Substance abuse, such as recreational drugs or smoking tobacco. Women chewing tobacco will not be excluded. Postnatal Phase:: Inclusion Criteria:
- Birth weight available within 72 hours
- Intention to breastfeed for 6 months
- Resides in the study area for the duration of the trial
See the full eligibility criteria
- Antenatal Phase::
- Gestational age confirmed by ultrasound to be 8-14 weeks
- Singleton and viable fetus on ultrasound
- A resident of the catchment area for at least the last six months
- Plans to stay within the catchment area during the pregnancy duration, during delivery and after birth of the baby.
- Has provided voluntary written informed consent
- Women with known allergies or intolerance to any components of the MMS or MMS PLUS being studied
- Women with pre-existing health conditions such as history of uncontrolled diabetes and hypertension or other chronic illnesses
- Substance abuse, such as recreational drugs or smoking tobacco. Women chewing tobacco will not be excluded. Postnatal Phase:: Inclusion Criteria:
- Birth weight available within 72 hours
- Intention to breastfeed for 6 months
- Resides in the study area for the duration of the trial
- Has provided voluntary written informed consent Exclusion Criteria:
- Congenital anomalies, birth defects, or severe neonatal complications
- Infants who are already receiving supplemental formula feeding or other nutritional supplements (except pre-lacteal feeding, vitamins, and medications)
- Infants whose mothers have conditions that significantly affect breastfeeding, such as severe postpartum depression, insufficient milk supply, or maternal use of medications that contraindicate breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Karachi, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 15 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Karachi, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.