PACTR202107604428217
Not yet recruiting
Phase 3
A Prospective PreecLampsia/Eclampsia Preventative Intervention – Metformin (APPLE PIE) study
ConditionsPregnancy and Childbirth
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pregnancy and Childbirth
- Sponsor
- Stellenbosch University
- Enrollment
- 1430
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All these criteria must be met to be eligible for inclusion:
- •A)At high risk of developing preeclampsia: Pregnant women who have chronic hypertension AND/OR have had a previous pregnancy complicated by preterm preeclampsia (before 34 weeks gestation) AND/OR had preeclampsia complicating 2 or more previous pregnancies
- •B)Gestational age between 12w 0d and 26w 0d
- •C)Viable singleton pregnancy
- •D)Be able to understand the information provided, with the use of an interpreter if needed, and be able to give informed consent
- •E)Be willing to take the trial medication daily until delivery
Exclusion Criteria
- •Any of the following will be considered an exclusion criterion:
- •A)Under 18 years of age
- •B)Known fetal anomaly
- •C)Unable or not willing to give consent
- •E)Contraindication to the use of metformin
- •F)Currently using metformin
- •G)Previously enrolled in this trial. Participants will only be able to enrol for this trial once and not again in the next pregnancy.
Outcomes
Primary Outcomes
Not specified
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