Condition category
Pregnancy and Childbirth
Date applied
27/01/2017
Date assigned
08/02/2017
Last edited
21/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Women in the late stages of pregnancy often want a quick delivery and sometimes wish to be induced (the use of medication to begin the process of labour) rather than waiting for labour to naturally occur. Women who have given birth vaginally before usually respond better to being induced as they have less complications and a lower rate of needing a caesarean section (the use of surgery to deliver a baby). By planning an induction date, deliveries can happen during normal work hours, which is both safer and more convenient for both the mother and the health care workers. The aim of this study is to compare birth outcomes and satisfaction with labour of women who are induced as compared to women who have standard labour (waiting for birth to occur naturally at 40-41 weeks).

Who can participate?
Adult women who are at least 38 weeks pregnant who have had a previous vaginal birth.

What does the study involve?
Participants who consent to participate are randomly allocated to having labour either induced or to having standard expectant care. Women allocated to having labour induced have a scheduled induction date once they reach 39 weeks of pregnancy. This involves being given an oxytocin (medication to induce birth) drip to begin the birthing process and then receiving standard care throughout the labour process. Women allocated to the standard expectant care have normal care with outpatient follow up, which involves waiting for birth to occur on its own. If they have not given birth by 41 weeks they are induced (according to the standard level of care). Participants are followed from recruitment until hospital discharge in order to determine their satisfaction with their birth experience and health outcomes of their babies.

What are the possible benefits and risks of participating?
There are no direct benefits to participant however participants may benefit from a faster delivery. Participants who are induced may experience less satisfactory care and poorer birth outcomes compared to participants who received standard care.

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?
September 2016 to January 2018

Who is funding the study?
University of Malaya (Malaysia)

Who is the main contact?
Dr Aida Othman

Trial website

Contact information

Type

Scientific

Primary contact

Dr Aida Othman

ORCID ID

http://orcid.org/0000-0003-3565-0516

Contact details

Dept Obstetrics & Gynaecology
University Malaya Medical Centre
Kuala Lumpur
59100
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UMMC MECID No. 2016927-4284 ; NMRR-17-31-33921

Study information

Scientific title

Induction of labour at 39 weeks or beyond in multiparous women with a favourable cervix: A randomised controlled trial

Acronym

Study hypothesis

The induction of labour at 39 weeks gestation in multiparous women with favourable cervixes compared to standard (expectant) care will result in higher patient satisfaction and permit a larger proportion of delivery during normal working hours (9am to 5pm on weekdays).

Ethics approval

University Malaya Medical Centre Medical Research and Ethics Committee, 8/01/2017, ref: 2016927-4284

Study design

Single-centre randomised 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

Healthy pregnancy at or after 39 weeks gestation

Intervention

Participants undergo an internal (vaginal) digital examination to assess the favourability of their cervix. Women with an unfavourable cervix (e.g. cervical opening less than 2 cm dilated) are ineligible for the trial and their usual care continues.

Eligible women, after providing written consent to participate, are randomised to one of two groups (labour induced or the control group) through opening the numbered sealed envelope containing their allocation. The randomisation sequence is generated using a computerised random number generator.

Group one (labour induced): Women assigned to induction of labour are given a date for their labour induction as soon as practicable upon reaching 39 weeks (if recruited at 39 weeks, as soon as possible). The appointment for labour induction is scheduled for at 8 am on a weekday. As the cervix is favourable, labour induction is expected to be initiated by breaking the water followed by a drip (oxytocin) to start contractions off. Management of labour induction is according to standard practice.

Group two (control): Women allocated to standard expectant care have normal care with outpatient follow up. This involves waiting for spontaneous labour and usually with recommendation to induce labour at 41 weeks if they still have not delivered, provided there are no interim issues identified. Management of labour induction is according to standard practice.

Participants are followed until their hospital discharge, and their babies are followed until their hospital discharge.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Delivery time (week day 9 am to 5 pm or other) is assessed from hospital records after hospital discharge
2. Maternal satisfaction of care is measured using a visual numerical rating score sheet and self-scored from 0-10, assessed after delivery

Secondary outcome measures

Maternal outcomes:
1. Mode of delivery is assessed from hospital records at hospital discharge
2. Oxytocin use in labour is assessed from hospital records at hospital discharge
3. Epidural use in labour is assessed from hospital records at hospital discharge
4. Number of antenatal clinic visits is assessed from hospital records at hospital discharge
5. Number of non-birth related hospital admissions after recruitment is assessed from hospital records at hospital discharge
6. Presentation at hospital admission for birth (i.e. spontaneous labour, induction of labour, prelabour rupture of membranes, planned caesarean section, and others) is assessed from hospital records at beginning of hospital stay
7. Blood loss is estimated using healthcare provider’s standard estimation at delivery
8. Fever is measured using a single temperature reading ≥ 38 degrees Celsius is extracted from hospital records measured during labour, after delivery and at hospital discharge
9. Duration of hospital stay for birth admission is assessed from hospital records at hospital discharge

Neonatal Outcomes:
1. Neonatal outcomes are measured by Apgar score at 5 minutes after birth
2. Neonatal admission to special care nursery or intensive care is assessed from hospital records at infant’s hospital discharge
3. Birth weight is assessed from hospital records at hospital discharge
4. Umbilical cord arterial blood pH and base excess is assessed from hospital records at hospital discharge

Overall trial start date

30/09/2016

Overall trial end date

31/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. At least one previous vaginal birth (birth after gestational age of 28 weeks and birth weight of over 1kg)
3. Gestational age of 38 weeks to 40 weeks at enrollment
4. Favourable cervix (Bishop Score ≥ 6 and likely to be suitable for amniotomy)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

160

Participant exclusion criteria

1. Previous caesarean section
2. Previous uterine surgery or uterine injury
3. Indication or anticipation (maternal or fetal) for early or urgent delivery
4. Contraindication for vaginal delivery

Recruitment start date

30/01/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Malaysia

Trial participating centre

University Malaya Medical Centre
Jalan University Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University Malaya Medical Centre

Sponsor details

Jalan University
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Universiti Malaya

Alternative name(s)

University of Malaya, UM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes