Regular (4-Hourly) compared with restricted (avoidance unless indicated) vaginal examination in labour induction with an oral misoprostol regime
| ISRCTN | ISRCTN68476694 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68476694 |
| Protocol serial number | 2016728-4061 |
| Sponsor | University Malaya |
| Funder | University Malaya |
- Submission date
- 15/11/2016
- Registration date
- 18/11/2016
- Last edited
- 18/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Although most labours begin naturally, however around one third of women need help to get started. In these cases, a healthcare professional will often “induce” labour. Although the aim of induction is to achieve a vaginal delivery, it is not always successful and some women end up having a caesarean section (an operation where the child is delivered through a cut in the abdomen). Misoprostol is a drug used as a cheap and effective way of inducing labour, and studies have found that its use has the lowest possibility of caesarean sections. It is common practice to perform vaginal examinations (VE) or assessments on a regular basis during induction of labour with this type of drug to assess progress so that the waters can be broken as soon as possible. Following breaking of the waters, the oxytocin (hormone) drip can then be started to produce strong contractions to speed up delivery of the baby. If misoprostol is given vaginally then VE’s are unavoidable, however if the drug is given by mouth then they may not be necessary. VE can cause discomfort and distress particularly with first time mothers. The aim of this study is to look at success of labour induction and patient satisfaction when participants receive the normal amount or a restricted amount of VE’s during induction of labour with misoprostol taken by mouth (oral).
Who can participate?
Pregnant women who need to have labour induced with misoprostol.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in both groups are given misoprostol by mouth every four hours to induce labour, with a maximum of three doses to be given in the first 12 hours. If this does not work, then the process is repeated after 24 hours. Those in the first group have a vaginal examination before every dose. Those in the second group only undergo vaginal examinations if there are signs that there is a problem or that the patient has moved to the next stage of labour. Participants in both groups are followed up 12 hours after labour is induced and after delivery to find out how successful the induction has been and whether the women are satisfied with their care.
What are the possible benefits and risks of participating?
There are no notable benefits involved with participating. There is a small risk that the restricted vaginal examination group may have a longer period between induction and delivery and there is a risk that those in the regular vaginal examination group are exposed to a higher number of potentially uncomfortable examinations.
Where is the study run from?
University Malaya Medical Centre (Malaysia)
When is the study starting and how long is it expected to run for?
July 2016 to August 2018
Who is funding the study?
University Malaya (Malaysia)
Who is the main contact?
1. Dr Win Sandar Tin (public)
2. Professor Tan Peng Chiong (scientific)
Contact information
Public
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
 ORCID ID |
0000-0002-8649-726X |
|---|
Scientific
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| ORCID ID |
0000-0001-8713-6581 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparing regular with restricted vaginal assessment in nulliparous women undergoing labour induction with oral misoprostol: a randomised trial |
| Study objectives | The aim of this study is to evaluate whether regular vaginal examinations (VEs) compared to a regimen where VEs are restricted, expedite the induction process and influence patient satisfaction in nulliparas undergoing oral misoprostol induction of labour. |
| Ethics approval(s) | Medical Ethics Committee, University Malaya Medical Center, 20/09/2016, ref: 2016728-4061 |
| Health condition(s) or problem(s) studied | Induction of labour at term in nulliparas (various indications) |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(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 |
| Key secondary outcome measure(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 |
| Completion date | 31/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 200 |
| Total final enrolment | 204 |
| Key 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 |
| Key exclusion criteria | 1. Patients with regular contractions (≥ 2 in 10 minutes) 2. Ruptured membranes 3. Previous uterine surgery 4. Known prostaglandins allergy |
| Date of first enrolment | 26/11/2016 |
| Date of final enrolment | 21/09/2017 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The trial data will be held at University Malaya and may be made available subject to specific approval by its ethics committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2019 | 18/12/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/12/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
12/10/2017: The recruitment end date was changed from 28/02/2018 to 21/09/2017.
