Preeclampsia Intervention Netherlands

Summary

The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child. Preterm PE affects about 1 in 100 pregnant individuals in the Netherlands. Signs of preterm PE can be high blood pressure and protein in the urine in the second half of pregnancy (but before 32-34 weeks of pregnancy). Other symptoms can develop, such as problems with blood clotting and how well the blood cells, liver, lungs, and brain work. The disease can lead to serious complications for both the mother and child. The only way to cure preterm PE is to make sure the child is born, and many times, children have to be delivered (very) early (before 37 weeks). Children born (very) early can suffer from infections, breathing difficulties, and problems in their development.

Metformin is a medicine used to treat high blood sugar during and outside of pregnancy. In a previous study in South Africa, women with preterm PE that used metformin were able to safely remain pregnant for an extra week. Similarly, the main goal of the Preeclampsia Intervention NetherLands (PI-NL) study is to see if patients with preterm PE in the Netherlands that use metformin can remain pregnant for a longer time than patients taking a placebo. A placebo is a look-a-like capsule that contains no active ingredients. Researchers, the treating medical team, and participants will not know which participant gets which treatment. In addition, all participants will receive the standard care that all preterm PE patients get.

Conditions

• Pre-Eclampsia Onset Less Than 37 Weeks
• Pre-Eclampsia
• Pre-Eclampsia; Complicating Pregnancy
• Pre-Eclampsia as Antepartum Condition
• Pre-eclampsia or Eclampsia With Pre-existing Hypertension
• Pre-Eclampsia; Affecting Fetus
• HELLP Syndrome Complicating Pregnancy
• HELLP Syndrome
• HELLP

Interventions

DRUG

Metformin Hydrochloride

Metformin Hydrochloride encapsulated immediate-release tablet of 500 mg, backfilled with cellulose.

DRUG

Placebo

Capsule filled with cellulose.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Amsterdam UMC

  lead OTHER

Principal Investigators

• R.C. Painter, Prof, MD, PhD · Amsterdam UMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-31

Primary Completion

2028-04-30

Completion

2028-07-31