Induction of labour in term pregnant women with one previous Caesarean delivery Pregnancy and Childbirth
Conditions
Interventions
Current intervention as of 05/12/2018:
Term women with one previous Caesarean section and unfavourable cervixes undergoing cervical ripening and induction of labour at term in Universi
Sponsors
Obstetrics and Gynaecology department of University Malaya
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Scheduled induction of labour 2. One previous Caesarean scar 3. Aged 18 years and above 4. Gestational age of >37 weeks at enrolment 5. Unfavourable cervix (Bishop Score =5) 6. Reassuring pre-induction fetal cardiotocography (CTG) 7. Cephalic presentation 8. Singleton pregnancy 9. Intact membranes 10. Absence of significant contraction =2 in 10 min
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 05/12/2018: 1. Allergic to latex 2. Allergy or other specific contraindication to dinoprostone 3. Inability to consent 4. Known gross fetal anomaly 5. Grand multiparity (number of pregnancy at or after 22 weeks =5) 6. Estimated fetal weight =2 kg or =4 kg Previous exclusion criteria: 1. Allergic to latex 2. Allergy or other specific contraindication to dinoprostone 3. Inability to consent 4. Known gross fetal anomaly 5. Parity(number of viable pregnancies) =5 6. Estimated fetal weight =2 kg or =4 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 05/12/2018: 1. Induction to delivery interval assessed using patient medical records and obtained as soon after delivery before discharge 2. Satisfaction of mother with the delivery process using a 10-cm visual analog scale (VAS) Previous primary outcome measures: 1. Induction to delivery interval assessed using patient medical records. 2. Satisfaction of mother with the delivery process using a 10-cm visual analog scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/12/2018: Maternal outcomes: 1. Maternal satisfaction with their care since allocation to the intervention until removal or expulsion of induction device using a 10-cm VAS – obtained as soon as possible after removal of catheter/device 2. Mode of delivery (obtained after delivery) 3. Switch over to alternate device (obtained after delivery) 4. Spontaneous rupture of membranes (SROM) or amniotomy: date and time (obtained after delivery) 5. Use of oxytocin for induction or intrapartum augmentation (obtained after delivery) 6. Use of epidural analgesia in labour (obtained after delivery) 7. Estimated delivery blood loss (obtained after delivery) 8. Fever =38°C (from induction to patient discharge - obtained after discharge) 9. Major complications (intervention to hospital discharge- obtained after discharge) 10. Major complications (scar rupture, blood transfusion, maternal HDU/ICU admission, hysterectomy, re-laparotomy, others) 11. Uterine hyperstimulation syndrome (in the first 24 hours - obtained after delivery) assessed using blinded assessor 12. Terbutaline use for uterine hyperstimulation (obtained after delivery) Neonatal outcomes: 1. Apgar score at 1 and 5 minutes after birth 2. Arterial cord pH 3. Birth weight 4. Neonatal admission All outcomes are assessed using patient medical records. Previous secondary outcome measures: Maternal outcomes: 1. Maternal satisfaction with their care since allocation to the intervention until removal of induction device using a 10-cm VAS – obtained as soon as possible after removal of catheter/device 2. Mode of delivery ( | — |
Countries
Malaysia
Contacts
Public ContactSivaranjani Sanmugam
Outcome results
None listed