Preeclampsia Intervention 4

Phase 3

Recruiting

Conditions: Preeclampsia

Registration Number: 2022-502707-29-00

Lead Sponsor: Vastra Gotalandsregionen, University Of Gothenburg

Brief Summary: To examine whether 3 grams of metformin ER daily can prolong gestation in pregnancies complicated by preterm preeclampsia diagnosed 22+0–33+6 weeks in women undergoing expectant management, compared to placebo.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 294

Inclusion Criteria

• A diagnosis of preeclampsia has been made by the attending clinician

• The managing clinicians have made the assessment to proceed with expectant management and that delivery is not expected within 48 hours

• The subject has given written consent to participate in the study.

• The woman must be 18 years of age or older

• The gestational age is between 22+0 weeks to 33+6 weeks with a viable fetus

• The woman carries a singleton pregnancy

Exclusion Criteria

• There are contraindications to treatment with metformin as outlined in SmPC (Attachment E)

• Not suitable for inclusion by the opinion of the investigator

• Contraindications for expectant management of preeclampsia such as an immediate indication for delivery according to Swedish guidelines.

Current use of metformin

• Known or suspected allergies against metformin

• Reluctance or language difficulties that result in difficulty understanding the meaning of study participation

• Unable to understand the informed consent process

• Previous participation in the study

• Established fetal compromise that necessitates imminent delivery (including planned delivery after 48 hours of corticosteroid treatment). This will be decided by the clinical team before expectant management is offered to the patient.

Diabetes type 1

• Suspicion of a major known fetal anomaly or malformation.

• Renal disease or dysfunction, suggested by a creatinine level greater than or equal to 125 µmol/L or rapidly declining renal function

• Known acute or chronic metabolic acidosis, including diabetic ketoacidosis

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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 Outcome Measures

Name	Time	Method
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.		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.		Neonatal birthweight, in grams.

Trial Locations

Locations (7): Danderyds Sjukhus AB
🇸🇪
Danderyd, Sweden
Region Oestergoetland
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Linkoping, Sweden
Uppsala University Hospital
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Uppsala, Sweden
Karolinska University Hospital
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Solna, Sweden
Region Skane - Skanes Universitetssjukhus
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Malmo, Sweden
Sahlgrenska University Hospital-Vastra Gotalandsregionen
🇸🇪
Gothenburg, Sweden
Region Dalarna
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Falun, Sweden
Danderyds Sjukhus AB
🇸🇪Danderyd, Sweden
Sophia Brismar Wendel
Site contact
0722024895
sophia.brismar-wendel@regionstockholm.se