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

Phase 3

• Conditions: Pregnancy and Childbirth

• Registration Number: PACTR202107604428217
• Lead Sponsor: Stellenbosch University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 1430

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
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of preeclampsia or super-imposed preeclampsia

Secondary Outcome Measures

Name	Time	Method
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