Trial · NCT06452498
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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). |
| Other | Rate of diarrhea, nausea/vomiting, abdominal pain, headache (all based on PHASE-20 questionnaire), lactic acidosis, and hypoglycemia (individually) | Randomization till delivery (up to 37 weeks of gestation) | Tolerability and safety of metformin |
| Other | Score on PROMIS Anxiety 8a Short Form | Randomization till 90 days postpartum | Maternal anxiety |
| Other | Score on EPDS | Randomization till 90 days postpartum | Maternal depressive symptoms |
| Other | Score on Rosenberg Self-Esteem Scale | Randomization till 90 days postpartum | Maternal self-esteem |
| Other | Score on City Birth Trauma Scale | Randomization till 90 days postpartum | Childbirth-related PTSD |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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