Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452498
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-31
Brief Title:
Preeclampsia Intervention Netherlands
Sponsor:
Amsterdam UMC
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Metformin for the Prolongation of Pregnancy in Preterm Preeclampsia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PI-NL
Brief 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 safer 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
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
Detailed Description:
Preterm preeclampsia PE is a severe hypertensive disorder of pregnancy and a major cause of maternal and perinatal morbidity and mortality Currently the only treatment to halt disease progression is delivery of the dysfunctional placenta and thereby the child This often happens prematurely Being able to safely for mother and child extend pregnancy even by a few days is expected to reduce the short- and long-term risks associated with severe prematurity Preclinical and recent clinical evidence presents metformin a drug commonly used to treat diabetes in and outside of pregnancy as a promising treatment candidate for preterm PE Metformin might reduce inflammation oxidative stress and anti-angiogenesis and improve endothelial function In a recent South African trial use of metformin was associated with a safe median 76 day prolongation of pregnancy in women with preterm PE compared to placebo There was a nonsignificant increase in the neonatal birthweight and a decrease in the length of stay in any neonatal nursery Metformin did not lead to any serious adverse events
The goal of this multicenter triple-blind randomized placebo-controlled trial is to investigate whether metformin can safely prolong gestation in patients with preterm PE in the Dutch population Secondary outcomes include composite adverse maternal fetal and neonatal outcomes Cost-effectiveness of the treatment will be evaluated
The goal of this multicenter triple-blind randomized placebo-controlled trial is to investigate whether metformin can safely prolong gestation in patients with preterm PE in the Dutch population Secondary outcomes include composite adverse maternal fetal and neonatal outcomes Cost-effectiveness of the treatment will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-510382-10-00 | CTIS | None | None |