Regular (4-Hourly) compared with restricted (avoidance unless indicated) vaginal examination in labour induction with an oral misoprostol regime
Not Applicable
Completed
- Conditions
- Induction of labour at term in nulliparas (various indications)Pregnancy and Childbirth
- Registration Number
- ISRCTN68476694
- Lead Sponsor
- niversity Malaya
- Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30633917 (added 18/12/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 204
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
1. Patients with regular contractions (= 2 in 10 minutes)
2. Ruptured membranes
3. Previous uterine surgery
4. Known prostaglandins allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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<br> 2. Induction to vaginal delivery interval is measured using recorded start of induction to recorded time of vaginal birth in her medical records<br> 3. Vaginal delivery rate in 24 hours is derived from dichotomization of induction to vaginal delivery data<br>
- Secondary Outcome Measures
Name Time Method