Reproductive Health & Childbirth Pregnancy and Childbirth Childbirth
Conditions
Interventions
Treatment group: Women over the age of 35 years with a singleton live fetus in a cephalic presentation will be assigned to induction of labour between 39 + 0/7 and 39 + 6/7 weeks.
Control group: Wom
Sponsors
Nottingham University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Nulliparous women who will be over 35 years at the expected date of delivery, with: 1. A singleton live fetus 2. A cephalic presentation 3. Gestational age between 36 weeks + 0 days and 39 weeks + 6 days 4. No medical contra-indication to induction of labour 5. No medical contra-indication to pregnancy being allowed to proceed to term plus 10 days 6. Willingness to participate in the trial 7. Written informed consent 8. Female participants
Exclusion criteria
Exclusion criteria: 1. Women with a known lethal fetal congenital abnormality. 2. Women with a contra-indication to labour or vaginal delivery (e.g. evidence of fetal compromise such that labour would be contra-indicated; fetal congenital anomaly or condition that might cause a mechanical problem at delivery such as hydrocephalus or cystic hygroma; placenta praevia) 3. Women with a contra-indication to expectant management (e.g. gestational diabetes, proteinuric hypertension (>250mg/l or BP > 140/90 on more than two occasions, two hrs apart) 4. Women with a previous myomectomy. 5. Women who book late for antenatal care and have no dating scan performed between before 22 weeks to provide an accurate EDD. 6. Women who have undergone IVF using donor eggs in the current pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Caesarean section | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcomes 1. Mode of delivery 1.1 Vaginal delivery 1.2 Assisted vaginal delivery (forceps or ventouse) 1.3 Caesarean section 2. Onset of labour 2.1 Spontaneous 2.2 Induction 2.3 Planned caesarean section 3. Indication for induction of labour 3.1 Randomised to treatment 3.2 Gestational age > 41 weeks 3.3 Preterm ( 37 weeks) prelabour rupture of membranes > 24 hours 3.5 Fetal growth restriction 3.6 Reduced fetal movements 3.7 Intrauterine fetal death 3.8 Pregnancy induced hypertension 3.9 Pre-eclampsia 3.10 Eclampsia 3.11 Obstetric cholestasis 3.12 Gestational diabetes 3.13 Suspected fetal distress 3.14 Maternal request 3.15 Other 4. Method of induction of labour (as many as apply) 4.1 Prostaglandin tablet regime 4.2 Prostaglandin gel regime 4.3 Prostaglandin slow-release pessary 4.4 Artificial rupture of amniotic membranes 4.5 Oxytocin 5. Indication for Caesarean section 5.1 Arrest of first stage of labour 5.2 Arrest of second stage of labour 5.3 Failed instrumental delivery 5.4 Fetal distress 5.5 Failure to progress and fetal distress 5.6 Maternal complication 5.7 Elective 5.9 Other 6. Intrapartum complications 6.1 Placental abruption 6.2 Cord prolapse 6.3 Postpartum haemorrhage 6.4 Shoulder dystocia 7. Postpartum morbidity 7.1Requiring blood transfusion 7.2Systemic infection ? temp > 38?C Neonatal outcomes 1. Live birth 2. Stillbirth (a baby delivered with no signs of life after 24 completed weeks of pregnancy) 3. Birth weight 4. Sex 5. Death before discharge from hospital 6. Apgar at 1 min 7. Apgar at 5 min 8. Apgar at 10 minutes ? allow missing data 9. Cord blood artery pH and BD ? allow missing data 10. Cord blood vein pH and BD ? allow missing data 11. NICU admission ? duration (days) 12. If no cord blood and NICU admission required ? first fetal pH obtained 13. Birth trauma 13.1 Subdural haematoma 13.2 Intracerebral or intraventricular haemorrhage 13.3 Spinal-cord injury 13.4 Basal skull fracture 13.5 Peripheral-nerve injury present at disc | — |
Countries
United Kingdom
Outcome results
None listed