Induction of labour at term in nulliparas (various indications) Pregnancy and Childbirth Induction of labour at term in nulliparas (various indications)
Conditions
Interventions
Participants are randomised to one of two groups using a random number generator in blocks of 4 or 8 in a 1:1 ratio.
Regular Vaginal Assessment group: A vaginal examination will be pe
Sponsors
University Malaya
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Scheduled induction of labour (various indications) with oral misoprostol 2. Nulliparous women (no previous vaginal delivery beyond 20 weeks of gestation) 3. Term gestation (on or after 37 weeks) 4. Singleton gestation 5. Reassuring pre-induction cardiotocograph 6. Cephalic indication 7. Participant aged 18 years old and above 8. No contraindication to vaginal delivery
Exclusion criteria
Exclusion criteria: 1. Patients with regular contractions (= 2 in 10 minutes) 2. Ruptured membranes 3. Previous uterine surgery 4. Known prostaglandins allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction with the birth process is evaluated using a 11-point visual numerical rating score (VNRS) self-marked by participants before discharge from hospitalisation for delivery 2. Induction to vaginal delivery interval is measured using recorded start of induction to recorded time of vaginal birth in her medical records 3. Vaginal delivery rate in 24 hours is derived from dichotomization of induction to vaginal delivery data | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction with the induction process is measured using a 11-point visual numerical rating score (VNRS) self-marked by participants at 12 hours after the start of labour induction 2. Patient preference on the vaginal assessment regime in a future labour induction is measured using Likert scale responses to a statement at 12 hours and before discharge from hospitalisation for delivery 3. Total numbers of vaginal examination in first 12 hours of labour induction is measured by abstracting from medical records after delivery 4. Total oral misoprostol doses used during birth process is measured by abstracting from medical records after delivery 5. Other modes (other prostaglandins, route, balloon) used for labour induction is measured by abstracting from medical records after delivery 6. Oxytocin use in labour is measured by abstracting from medical records after delivery 7. Epidural in labour is measured by abstracting from medical records after delivery 8. Mode of delivery is measured by abstracting from medical records after delivery 9. Delivery blood loss is measured by abstracting from medical records after delivery 10. Neonatal condition… is measured using the Apgar score at 5 minutes by abstracting from neonatal medical records after delivery 11. Admission of newborn to neonatal ward is measured by abstracting from neonatal medical records after delivery 12. Cord blood pH and base excess is measured by abstracting from neonatal medical records after delivery 13. Induction to hospital discharge interval (maternal) is measured by using recorded date of start of labour induction and date of hospital abstracting from medical records | — |
Countries
Malaysia
Contacts
Public ContactWin Sandar Tin
Outcome results
None listed