Metformin for the prolongation of pregnancy in preterm preeclampsia: the PI-NL trial

Conditions

HELLP syndrome, Hypertensive disorders of pregnancy, Preterm preeclampsia

Brief summary

Gestational prolongation (in days)

Detailed description

Combined endpoint of maternal adverse outcome, consisting of maternal death (death during pregnancy or within 42 days of delivery), eclampsia, pulmonary edema, severe renal impairment, cerebrovascular accident, placental abruption, and/or liver hematoma or rupture., Combined endpoint of fetal adverse outcome, consisting of intrauterine fetal death (IUFD, including intrapartum death), suboptimal fetal condition based on the heart rate pattern on the CTG (as judged by the treating clinician), and/or fetal growth restriction (FGR), Combined endpoint of neonatal adverse outcome, consisting of neonatal death (within 28 days of birth), intraventricular hemorrhage (grade III or IV), retinopathy of prematurity requiring treatment, necrotizing enterocolitis (grade II or higher), bronchopulmonary dysplasia, neonatal sepsis, and/or cystic periventricular leukomalacia (grade II or higher)

Related papers

No related papers found yet.

Interventions

DRUGMetformine HCl 500 mg Teva

DRUGfilmomhulde tabletten

DRUGMicrocrystalline cellulose

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Gestational prolongation (in days)	—

Secondary

Measure	Time frame
Combined endpoint of maternal adverse outcome, consisting of maternal death (death during pregnancy or within 42 days of delivery), eclampsia, pulmonary edema, severe renal impairment, cerebrovascular accident, placental abruption, and/or liver hematoma or rupture., Combined endpoint of fetal adverse outcome, consisting of intrauterine fetal death (IUFD, including intrapartum death), suboptimal fetal condition based on the heart rate pattern on the CTG (as judged by the treating clinician), and/or fetal growth restriction (FGR), Combined endpoint of neonatal adverse outcome, consisting of neonatal death (within 28 days of birth), intraventricular hemorrhage (grade III or IV), retinopathy of prematurity requiring treatment, necrotizing enterocolitis (grade II or higher), bronchopulmonary dysplasia, neonatal sepsis, and/or cystic periventricular leukomalacia (grade II or higher)	—

Measure

Time frame

Combined endpoint of maternal adverse outcome, consisting of maternal death (death during pregnancy or within 42 days of delivery), eclampsia, pulmonary edema, severe renal impairment, cerebrovascular accident, placental abruption, and/or liver hematoma or rupture., Combined endpoint of fetal adverse outcome, consisting of intrauterine fetal death (IUFD, including intrapartum death), suboptimal fetal condition based on the heart rate pattern on the CTG (as judged by the treating clinician), and/or fetal growth restriction (FGR), Combined endpoint of neonatal adverse outcome, consisting of neonatal death (within 28 days of birth), intraventricular hemorrhage (grade III or IV), retinopathy of prematurity requiring treatment, necrotizing enterocolitis (grade II or higher), bronchopulmonary dysplasia, neonatal sepsis, and/or cystic periventricular leukomalacia (grade II or higher)

—

Countries

Netherlands

Outcome results

None listed