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Preeclampsia Intervention 4 – A double blind phase III randomised controlled trial assessing metformin to prolong gestation in preterm preeclampsia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502707-29-00
Acronym
PI4
Enrollment
294
Registered
2023-05-31
Start date
2024-02-07
Completion date
Unknown
Last updated
2025-12-17

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

Conditions

Preeclampsia

Brief summary

The primary endpoint is prolongation of gestation, defined as days and hours from randomisation to delivery. Prolongation of gestation in pregnancies with intrauterine fetal demise will be considered as interval censored between time from randomisation to last visit preceding delivery (where the baby was known to be alive) and time from randomisation to delivery.

Detailed description

Length of neonatal stay, defined as days and hours from birth to discharge from neonatal care, including both hospital and home-based care. Length of neonatal stay will be as zero if the infant was not admitted to neonatal care., Neonatal birthweight, in grams.

Interventions

DRUGGlucophage XR 500 mg RM Placebo

Sponsors

Vastra Gotalandsregionen, University Of Gothenburg
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint is prolongation of gestation, defined as days and hours from randomisation to delivery. Prolongation of gestation in pregnancies with intrauterine fetal demise will be considered as interval censored between time from randomisation to last visit preceding delivery (where the baby was known to be alive) and time from randomisation to delivery.

Secondary

MeasureTime frame
Length of neonatal stay, defined as days and hours from birth to discharge from neonatal care, including both hospital and home-based care. Length of neonatal stay will be as zero if the infant was not admitted to neonatal care., Neonatal birthweight, in grams.

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026