Nulliparity and post-term pregnancy Pregnancy and Childbirth Nulliparity and post-term pregnancy
Conditions
Interventions
Current version as of 04/04/2018:
Randomisation is performed by computer-sequenced block randomisation technique. The first randomisation (timing of labour induction) is performed at 41+0 gestational
Sponsors
Helsinki University Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pregnant women 2. Age =18 years 3. Nulliparous 4. Gestational age 41+0 weeks 5. Singleton pregnancy 6. Live fetus 7. Cephalic presentation 8. Intact amniotic membranes 9. Unfavourable cervix (Bishop score < 6) 10. Uncomplicated pregnancy (no pregnancy complications that require induction of labour) 11. Ability to understand oral and written information
Exclusion criteria
Exclusion criteria: 1. Multiple pregnancy 2. Breech or transverse presentation 2. Fetal malformation detected antenatally 3. Multiparous women 4. Women with a history of previous caesarean section or transfundal uterine surgery 5. Pregnancy complication that requires intervention (such as preeclampsia, intrauterine growth restriction, pregestational diabetes and insulin-dependent gestational diabetes) 6. Premature rupture of membranes 7. Clinical vaginal infection or chorionamnionitis 8. Fetal macrosomia (antenatally estimated weight = 4.5 kg) 9. Maternal HIV, hepatitis B or C 10. Contraindication for vaginal delivery (such as low lying placenta or vasa previa) 11. No informed consent received
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of caesarean section is measured at birth using the mode of delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current version as of 04/04/2018: 1. Primary neonatal outcome are measured using 1 and 5 minute Apgar scores, umbilical artery blood pH and base excess values at birth, and intubation at birth 2. Neonatal intensive care episodes is measured using patient notes on admissions to neonatal intensive care unit during the first 24 hours after birth 3. Neonatal care episodes is measured using patient notes on admissions to neonatal ward during the first 24 hours after birth 4. Placental retention is measured at 1 hour from birth using the definition that surgical or pharmacological interventions are needed for placental expulsion 5. Maternal haemorrhage is measured by volume of bleeding in milliliters or weight of bleeding in grams at birth 6. Perineal tears is measured using sphincter injury at birth 7. Intrapartum and postpartum infections is measured at labour and during post-partum care episode, using any two of the criteria: maternal fever = 38°C, fetal tachycardia, purulent discharge, uterine tenderness, and white cell count > 20 8. Maternal satisfaction is measured using Childbirth Experience questionnaire (CEQ) Original version: 1. Primary neonatal outcome are measured using 1 and 5 minute Apgar scores, umbilical artery blood pH and base excess values at birth, and intubation at birth 2. Neonatal intensive care episodes is measured using patient notes on admissions to neonatal intensive care unit during the first 24 hours after birth 3. Neonatal care episodes is measured using patient notes on admissions to neonatal ward during the first 24 hours after birth 4. Placental retention is measured at 1 hour from birth using the definition that surgical or pharmacological interventions are needed for placental expulsion 5. Maternal haemorrhage is measured by volume of bleeding in milliliters or weight of bleeding in grams at birth 6. Perineal tears is measured using sphincter injury at birth 7. Intrapartum and postpartum infections is measured at labour and during post | — |
Countries
Finland
Outcome results
None listed