Condition category
Pregnancy and Childbirth
Date applied
20/09/2020
Date assigned
22/09/2020
Last edited
05/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Labour induction — also known as inducing labour — is the stimulation of uterine contractions during pregnancy before labour begins on its own to achieve a vaginal birth. A health care provider might recommend labour induction for various reasons, primarily when there's a concern for a mother's health or a baby's health. One of the most important factors in predicting the likelihood of successful labour induction is how soft and distended the opening of the womb (cervix) is.
The frequency of induction of labour has dramatically risen over the last decades. Mechanical induction using an inflatable balloon on a tube placed into the cervix (Foley catheter) is a common induction method. Typically, patients who are induced with a Foley catheter will not have a contraction on their own, therefore the usage of the drug 'oxytocin' combined with artificial rupture of the amniotic sac (waterbag that surrounds the baby) is usually needed to initiate labour. (Oxytocin is a drug that can make contractions stronger and more regular and can start to work quite quickly).
The aim of this study is to investigate the hypothesis that early artificial opening of the amniotic sac (amniotomy) and immediate oxytocin will shorten labour duration.

Who can participate?
Women who have not previously given birth (nulliparous) who are over 37 weeks pregnant and planned for induction with a Foley catheter.

What does the study involve?
Participants will be randomly allocated to receive immediate amniotomy and administration of oxytocin or will receive oxytocin and amniotomy after 4 hours, or earlier if warranted. After the delivery, participants will be asked to provide their level of satisfaction with the delivery.

What are the possible benefits and risks of participating?
Benefits: The procedure may shorten the birth process and improve satisfaction in the birth process. Information obtained from this study will help to improve the management of labour in the future.
Risks: Amniotomy can cause some pain and discomfort. Oxytocin can cause changes in fetal heart monitoring. Major complications are not anticipated.

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?
April 2020 to January 2021

Who is funding the study?
University Malaya Medical Centre (Malaysia)

Who is the main contact?
Nur Adlyn Binti Hasan
adlynhasan@gmail.com.my

Trial website

Contact information

Type

Public

Primary contact

Dr Nur Adlyn Hasan

ORCID ID

Contact details

Kompleks Wanita dan Kanak-Kanak
University Malaya Medical Centre
Kuala Lumpur
50603
Malaysia
+60 (0)3 7949 4422
adlyn@ummc.edu.my

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NMRR-20-1797-55559

Study information

Scientific title

Immediate oxytocin and early amniotomy versus immediate oxytocin and delayed amniotomy following cervical ripening with foley catheter in nulliparous women

Acronym

Study hypothesis

Nulliparous receiving titrated oxytocin infusion after Foley ripening for labour induction, concurrent amniotomy (with the start of oxytocin infusion) compared to delayed amniotomy will shorten the interval to delivery.

Ethics approval

Approved 12/09/2020, Medical Research Ethics Committee, University Malaya Medical Centre (Lembah Pantai, 59100 Kuala Lumpur, Malaysia; +60 379493209; ummc@ummc.edu.my), ref: 2020623-8808

Study design

Single- center interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

induction of labour in nulliparous pregnant women

Intervention

All nulliparous women having Foley catheter insertion are recruited in our delivery suite and antenatal ward. Eligible women will be provided with a patient information sheet and written consent will be taken. After the removal of the Foley catheter or spontaneous expulsion of the catheter, the vaginal examination will be performed, and those women with cervical dilatation of ≥3cm will be randomized to either early amniotomy and oxytocin group or oxytocin and delayed amniotomy group. The randomisation will be carried out by sealed envelope.
Women who in the early amniotomy group will have amniotomy done followed by IV oxytocin administration.
Women in the delayed amniotomy group will receive IV oxytocin and planned amniotomy after 4 hours, or earlier if warranted.
All the primary and secondary outcomes are collected after delivery.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Intervention to delivery interval measured as the time (min) from oxytocin initiation to delivery of the baby

Secondary outcome measures

Maternal outcome:
1. Caesarean rate measured as the percentage of women delivered via caeserean delivery at the end of study using patient records
2. Maternal satisfaction with the birth process using visual numerical rating scale at delivery
3. Intrapartum and postpartum fever (temperature of 38C or greater) reported throughout the process of labour and within 24 hours after delivery
4. Analgesic used in labour that is reported throughout the process of labour and measured at the time of delivery using case report forms
5. Delivery blood loss documented upon delivery and measured at the time of delivery using case report forms
6. Uterine hyperactivity defined as six or more contractions in 10 minutes over two consecutive 10-minute periods or sustained contraction 2 min or longer or association with fetal heart rate abnormality which documented throughout the labour process and measured at delivery using case report forms
7. CTG abnormality defined as suspicious or pathological according to NICE guideline 2017 and documented throughout the labour process and measured after delivery using case report forms
8. Mode of delivery with indication documented upon delivery and measured at the time of delivery using case report forms

Neonatal outcome:
1. Apgar score at 1 and 5 min documented upon delivery and measured at the time of delivery using case report forms
2. Arterial cord pH & Base excess documented upon delivery and measured at the time of delivery using case report forms
3. Birth weight measured using weigh scale and documented upon delivery using case report forms
4. Neonatal care admission measured using patient records:
4.1. Admission to NICU after delivery within 24 hours of delivery
4.2. Admission to Paediatric ICU after delivery within 24 hours of delivery
4.3. Admission to Special care nursery after delivery within 24 hours of delivery

Overall trial start date

01/04/2020

Overall trial end date

31/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Female aged 18 years and above
2. Nulliparous
3. Gestational age of ≥37 weeks at enrolment Scheduled induction of labour (Gestational age estimations supported by ultrasonographic dating)
4. Planned labour induction
5. Singleton pregnancy
6. Cephalic presentation
7. Women who had a cervical ripening with Foley catheter only and favourable cervix with cervical dilatation of 3 cm or greater (suitable for amniotomy) with contraction every 1 to 5 min
8. Intact membranes
9. Reassuring cardiotocogram

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

140

Participant exclusion criteria

1. Previous uterine incision/ injury (caesarean delivery, myomectomy, perforation)
2. Gross fetal anomaly
3. Contraindication for vaginal birth
4. Fetal weight clinically estimated to be ≤2 kg or ≥4kg before induction and confirmed by ultrasound
5. Ruptured membranes

Recruitment start date

25/09/2020

Recruitment end date

31/01/2021

Locations

Countries of recruitment

Malaysia

Trial participating centre

University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University Malaya Medical Centre

Sponsor details

Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+60 (0)3 7949 4422
ummc@ummc.edu.my

Sponsor type

Hospital/treatment centre

Website

http://ummc.edu.my

Funders

Funder type

Hospital/treatment centre

Funder name

University Malaya Medical Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The protocol is not available online but can be provided upon request.

IPD sharing statement
The datasets generated and/or analysed during the current study will available upon request from the principal investigator (Nur Adlyn Hasan; adlyn@ummc.edu.my) after the overall trial end date. Datasets are confidential and any data sharing will have to go through the Medical Research Ethics Committees at University Malaya Medical Centre.

Intention to publish date

31/01/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/10/2020: The recruitment start date was changed from 01/10/2020 to 25/09/2020. 21/09/2020: Trial’s existence confirmed by University of Malaya Medical Centre