Trial · NCT06452498
Preeclampsia Intervention Netherlands
NCT06452498, Phase 3, Recruiting, Amsterdam UMC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Preeclampsia Intervention Netherlands. Trials, record NCT06452498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06452498
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preeclampsia Intervention Netherlands
- NCT number
- NCT06452498
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 180 participants, estimated
- Lead sponsor
- Amsterdam UMC
- 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
- Metformin Hydrochloride, Placebo
- First posted
- 2024-06-11
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of days between randomization and delivery | Time between randomization and delivery (up to 37 weeks of gestation) | Prolongation of gestation |
| Secondary | Number of participants reaching a composite maternal adverse outcome | Randomization till 90 days postpartum (unless otherwise specified) | Combined endpoint of maternal death (during pregnancy or within 42 days postpartum), eclampsia, pulmonary edema, severe renal impairment, cerebrovascular accident, placental abruption, and/or liver hematoma or rupture. |
| Secondary | Number of participants reaching a composite fetal adverse outcome | Randomization till delivery (up to 37 weeks of gestation) | Combined endpoint of intrauterine fetal demise, suboptimal fetal condition based on CTG, and fetal growth restriction. |
| Secondary | Number of participants reaching a composite neonatal adverse outcome | Birth till 90 days after birth (unless otherwise specified) | Combined endpoint of neonatal death (within 28 days after birth), grade 3 or 4 intraventricular hemorrhage, retinopathy of prematurity requiring treatment, necrotizing enterocolitis (grade II or higher), bronchopulmonary dysplasia, neonatal sepsis, and cystic periventricular leukomalacia (grade II or higher) |
| Other | Maternal individual exploratory outcomes | Randomization till 90 days postpartum (unless otherwise specified) | Number of participants experiencing each of the following: maternal death, cerebrovascular event, eclampsia, cortical blindness, pulmonary edema, AKI, liver hematoma/rupture, placental abruption, retinal detachment, postpartum hemorrhage, HELLP syndrome, severe elevated liver enzymes, low platelets, left ventricular heart failure, PRES, DIC, thromboembolic disease, need for dialysis due to renal failure, admission to high or ICU, need for intubation and mechanical ventilation |
| Other | Fetal individual exploratory outcomes | Randomization till 90 days postpartum (unless otherwise specified) | Number of participants experiencing each of the following: intrauterine or intrapartum fetal death, reversed end diastolic flow in umbilical artery on at least 2 occasions, redistribution in the middle cerebral artery, absent or reversed a-wave in ductus venosus, suboptimal fetal condition based on CTG. |
| Other | Neonatal individual exploratory outcomes | Randomization till 90 days postpartum (unless otherwise specified) | Number of participants experiencing each of the following: neonatal death within 28 days after birth, neonatal death between 29 and 90 days after birth, growth restriction at birth, Apgar score \< 7 at 5 min, umbilical artery pH \< 7.10, neonatal hypoglycemia, neonatal seizures, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of the premature, pulmonary insufficiency of the preterm infant, bronchopulmonary dysplasia, cystic periventricular leukomalacia, patent ductus arteriosus, persistent pulmonary hypertension, surfactant use within 72 hours after birth, need for respiratory support, admission to NICU. |
| Other | Mean neonatal birthweight | Within the first 24 hours after birth | In grams |
| Other | Median neonatal length of stay in any neonatal nursery, including NICU | Birth till 90 days postpartum | In days |
| Other | Incremental cost-effectiveness ratios (ICERs; exploratory) | Start of pregnancy till 90 days postpartum | Determined through length of maternal stay in hospital (and specifically ICU), neonatal length of stay in hospital (and specifically NICU), other health care utilization (based on iMCQ questionnaire, maternal and neonatal use of medication during pregnancy and after birth), loss of productivity (measured with iPCQ questionnaire), quality-of-life (score on EQ-5D-5L). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06452498
GET https://conductscience.org/api/trials/v1/NCT06452498/registered