Regular (4-Hourly) compared with restricted (avoidance unless indicated) vaginal examination in labour induction with an oral misoprostol regime

• Register: ISRCTN
• Last refreshed on: 13 January 2020
• Main ID: ISRCTN68476694
• Date of registration: 18/11/2016
• Prospective Registration: Yes
• Primary sponsor: University Malaya
• Public title: Regular (4-Hourly) compared with restricted (avoidance unless indicated) vaginal examination in labour induction with an oral misoprostol regime
• Scientific title: Comparing regular with restricted vaginal assessment in nulliparous women undergoing labour induction with oral misoprostol: a randomised trial
• Date of first enrolment: 26/11/2016
• Target sample size: 200
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN68476694
• Study type: Interventional
• Study design: Single-centre randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Malaysia

Contacts

• Name: Tan Peng Chiong

• Name: Win Sandar Tin

Key inclusion & exclusion 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:
1. Patients with regular contractions (= 2 in 10 minutes)
2. Ruptured membranes
3. Previous uterine surgery
4. Known prostaglandins allergy


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Induction of labour at term in nulliparas (various indications)
Pregnancy and Childbirth
Induction of labour at term in nulliparas (various indications)

Intervention(s)

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 performed with a view to performing amniotomy and commence titrated oxytocin infusion if the cervix is found to be suitable preceding each scheduled 4-hourly dose of oral misoprostol.

Restricted Vaginal Assessment group: Each 4-hourly 3-dose schedule of oral misoprostol may be administered without a prior vaginal assessment unless specific indications are present. Indications for vaginal assessment are:
1. Membrane rupture
2. Excessive vaginal bleeding
3. Suspected uterine overstimulation
4. Fetal concerns
5. Maternal concerns
6. Suspicion of established labour (e.g. need for strong analgesia like an epidural)
7. Suspicion of second stage of labour

In both groups, oral misoprostol is administered every 4 hours (at commencement, then 4 and 8 hours later) to induce labour. A maximum of 3 doses may be administered in the first 12 hours. Patients who are not sufficiently responsive and still requiring cervical ripening may have the process repeated after 24 hours.

Routine standard of care applies to both trial arms in all other aspects. Care providers may manage (including additional vaginal assessments or omitting oral misoprostol) during the 8-hour study period at their sole discretion based on perceived clinical need of the participants.

Participants in both groups are followed up 12 hours after commencement of labour induction and then again after delivery.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

2016728-4061

Source(s) of Monetary Support

University Malaya

Ethics review

Status:
Approval date:
Contact:

Medical Ethics Committee, University Malaya Medical Center, 20/09/2016, ref: 2016728-4061

Results

• Results available: Yes
• Date Completed: 31/08/2018