NCT06452498RecruitingPhase 3
Preeclampsia Intervention Netherlands
Metformin for the Prolongation of Pregnancy in Preterm Preeclampsia
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 31 May 2024
- Start date
- 19 Sept 2025
- Primary completion date
- 19 Mar 2029
- Lead sponsor
- Amsterdam UMC
- Diseases
- High blood pressure
- NCT number
- NCT06452498
- EU CT number
- 2023-510382-10-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 180
- From 19 Sept 2025 to the primary completion date, 19 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of drugs that might interact with metformin
Other illness
- A decision for immediate delivery (including cases where corticosteroids are administered with planned delivery directly after completion of treatment) or termination of pregnancy (e.g., due to disease severity in the patient combined with a dismal prognosis for the fetus), as made by the treating multidisciplinary team and the parent(s)
- Contraindication(s) for the use of metformin (e.g., severe renal insufficiency, acute metabolic acidosis, severe liver insufficiency)
Other
- Any of the following:
- Current use of metformin or a clinical indication for the use of metformin
- Suspicion of a major fetal anomaly and/or chromosomal abnormality
- Unable or unwilling to (completely) understand or provide informed consent, due to language, culture, or other barriers
Who the study is looking for
- All of the following:
- Aged 18 years or older
- Singleton pregnancy
- Gestational age between 23+0 and 31+6 weeks
- A diagnosis of preterm preeclampsia, defined according to modified International Society for the Study of Hypertension in Pregnancy (ISSHP) classification, including only those who have proteinuria (≥300 mg of protein in a 24-hour urine specimen or a protein-creatinine-ratio \>50 in a single urine sample)
- Estimated fetal weight \>400 grams
- No clear indication (maternal or fetal) or intention, by both the treating multidisciplinary team and the patient after counseling, to immediately deliver (or directly after corticosteroid administration) or to terminate the pregnancy otherwise.
- Ability to understand English or Dutch
- Ability and willingness to provide written informed consent
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.