Preeclampsia Intervention Netherlands

Sponsor
Amsterdam UMC
Study ID
NCT06452498
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride — DRUG
    Metformin Hydrochloride encapsulated immediate-release tablet of 500 mg, backfilled with cellulose.
  • Placebo — DRUG
    Capsule filled with cellulose.

Study Details

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.

Key Dates

Start date
Aug 31, 2024
Status verified
Jun 2024
Primary completion
Apr 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin
    Metformin 3000 mg divided by three daily doses (3 times 2 capsules of 500 mg; following a step-up schedule) from randomization till delivery, aside from usual preterm preeclampsia care.
  • Placebo Comparator: Placebo
    Placebo, divided by three daily doses (3 times 2 capsules; following a step-up schedule) from randomization till delivery, aside from usual preterm preeclampsia care.

Primary Outcome Measure

Number of days between randomization and delivery [ Time Frame: Time between randomization and delivery (up to 37 weeks of gestation) ]

Central Contacts

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