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A Prospective PreecLampsia/Eclampsia Preventative Intervention – Metformin (APPLE PIE) study

A Prospective PreecLampsia/Eclampsia Preventative Intervention – Metformin (APPLE PIE) study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202107604428217
Enrollment
1430
Registered
2021-07-08
Start date
2022-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth

Interventions

Sponsors

Stellenbosch University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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 D) Diabetes 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.

Design outcomes

Primary

MeasureTime frame
Diagnosis of preeclampsia or super-imposed preeclampsia

Secondary

MeasureTime frame
Diagnosis of preeclampsia or super-imposed preeclampsia <37 weeks;Diagnosis of preeclampsia or super-imposed preeclampsia <34 weeks;Diagnosis of any hypertensive disorder of pregnancy after enrollment

Countries

South Africa

Contacts

Public ContactCatherine Cluver

Associate Professor

cathycluver@sun.ac.za+27823210298

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026