threatened preterm labour
Conditions
Interventions
Prior to randomization, all patients will undergo measurement of cervical
length and, in case of unruptured membranes, measurement of cervical
fibronectin and vaginal examination. All women will the
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women with a gestational age between 24+0 and 31+6 weeks who are spontaneously in labour, and who have been treated for 48 hours with tocolytics.
Exclusion criteria
Exclusion criteria: Women with signs of intra-uterine infection, women whose child has signs of fetal distress (abnormal CTG or biophysical profile) or major congenital malformation and women with any contraindication for the use of nifedipine or having a maternal disease (severe hypertension, HELLP syndrome, preeclampsia or other) or other reason for delivery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome measure will be a composite neonatal morbidity status, including perinatal death, chronic lung disease (CLD) and severe respiratory distress syndrome (IRDS), intra ventricular hemorrhage (IVH) grade 3 and 4, periventricular leukomalacia (PVL) and necrotizing enterocolitis (NEC) at the calculated term date. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be gestational age at delivery, number of days in NICU, and total days in hospital and costs. | — |
Countries
Netherlands
Outcome results
None listed