Condition category
Pregnancy and Childbirth
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
28/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Dan Selo-Ojeme

ORCID ID

Contact details

Consultant Obstretrician and Gynaecologist
Chase Farm Hospital
The Ridgeway
Enfield
EN2 8JL
United Kingdom
+44 02083751250
dan.selo-ojeme@bcf.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0270181703

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to compare the efficacy of amniotomy (breaking baby's bag of waters) and immediate syntocinon (oxytocin) infusion with amniotomy and delayed syntocinon infusion in induction of labour at term.

Ethics approval

Added 8 September 2008: Barnet, Enfield & Haringey Local Ethics Committee (UK), 20/01/2006, Ref Number 05/Q0509/65.

Study design

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 the contact details below to request a patient information sheet

Condition

Pregnancy and Childbirth: Labour induction

Intervention

Amniotomy and immediate oxytocin infusion versus amniotomy and delayed oxytocin

Intervention type

Drug

Phase

Not Specified

Drug names

oxytocin

Primary outcome measures

The proportion of women in active labour after 4 hours and over the course of time

Secondary outcome measures

Added 8 September 2008:
1. Mode of delivery
2. Need for epidural analgesia
3. Incidence of uterine hyperstimulation
4. Abnormal fetal heart recordings (by CTG)
5. 5-minute Apgar score < 7
6. Umbilical arterial cord pH < 7.2
7. Admission to neonatal intensive care unit
8. Women’s satisfaction

Overall trial start date

09/01/2005

Overall trial end date

03/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Women that will be invited to take part in the study will be drawn from the antenatal clinic. These women will be identified during routine antenatal clinic sessions. They will be women in their first pregnancy who have past their delivery dates and are thus planned for routine induction of labour. Interested patients will be given the patient information leaflet to take home.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

112

Participant exclusion criteria

Added 8 September 2008:

Women who decline to participate or with:
1. Preterm pregnancies
2. Multiple pregnancies
3. Regular uterine contractions (≥1 in 10 minutes)
4. Abnormal pre-induction fetal heart rate trace
5. Rupture of membranes
6. Significant fetal or maternal medical condition
7. Previous uterine surgery

Recruitment start date

09/01/2005

Recruitment end date

03/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Obstretrician and Gynaecologist
Enfield
EN2 8JL
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Barnet and Chase Farm Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18958483

Publication citations

  1. Results

    Selo-Ojeme DO, Pisal P, Lawal O, Rogers C, Shah A, Sinha S, A randomised controlled trial of amniotomy and immediate oxytocin infusion versus amniotomy and delayed oxytocin infusion for induction of labour at term., Arch. Gynecol. Obstet., 2009, 279, 6, 813-820, doi: 10.1007/s00404-008-0818-x.

Additional files

Editorial Notes