Welcome
Support Centre
25 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Effect of coital activity on onset of labour in women scheduled for labour induction: a randomised controlled trial
ISRCTN ISRCTN17998696
DOI 10.1186/ISRCTN17998696
ClinicalTrials.gov identifier
EudraCT number
Public title Effect of coital activity on onset of labour in women scheduled for labour induction: a randomised controlled trial
Scientific title
Acronym N/A
Serial number at source 492.7
Study hypothesis Pregnant women with an appointment for labour induction at term:
1. Will respond to counseling to have vaginal sex as frequently as possible to promote labour onset, and
2. Spontaneous labour onset rate will increase as result
Lay summary
Ethics approval Received from the Medical Ethics Committee University Malaya Medical Centre on the 15th March 2005 (ref: HU-61/12/1-1).
Study design A randomised controlled trial
Countries of recruitment Malaysia
Disease/condition/study domain Pregnancy: labour induction
Participants - inclusion criteria Pregnant women:
1. Given an appointment for non urgent labor induction at term
2. Viable foetus
3. Singleton
4. Cephalic presentation
5. Intact membranes
Participants - exclusion criteria 1. Previous caesarean section
2. Known gross foetal anomaly
Anticipated start date 01/12/2005
Anticipated end date 31/08/2007
Status of trial Completed
Patient information material
Target number of participants 209
Interventions Counselling to encourage vaginal sex versus no counselling.

Intervention:
1. Counselling by a single investigator (identifiable to women as a doctor) after recruitment
2. Inform women that sexual intercourse is safe and can promote onset of labour
3. Inform women that induced labour is associated with operative delivery and is a more prolonged process compared to spontaneous labour
4. Advise women to have vaginal sex as frequently as possible before their appointment for labour induction to promote labour
5. Ask women to keep a daily diary on vaginal sexual intercourse and any orgasms (marking day when vaginal sex occurs and similarly orgasm if any)

The above intervention/counselling usually takes about 5 to 15 minutes depending on queries. If there are any queries, the response is generally supportive of having sex. The aim is to encourage vaginal sex to promote labour.

Control:
1. Interaction with same investigator
2. Keep session as brief as possible
3. Inform women that sexual intercourse is safe but the effect on labour onset is unclear
4. Ask women to keep diary as above

The above process usually takes about five minutes - most of the time will be on instructions about diary entries. If there are any queries, refer women to standard information leaflet (made available to all trial women - neutral content). The aim is not to influence coital activity in control women.

The intervention comprises of a single counselling session as above. Providers are blind to randomisation. The appointments for labour induction are typically made for within the week ahead. Diaries are collected as soon as possible after delivery. Other outcome measures extracted from clinical notes after delivery. Women who miss their appointment for labour induction are contacted by telephone for information.
Primary outcome measure(s) 1. Reported coital activity from diary (kept from recruitment to delivery - expected to be only days worth in most instances)
2. Labour onset on or before appointment for labour induction: spontaneous labour (defined as spontaneous uterine contractions resulting in cervical dilatation of at least 3 cm) or pre-labour rupture of membranes on or before appointment date for labour induction

Primary outcomes should typically be resolved within one week of recruitment (no requirement for long term follow up).
Secondary outcome measure(s) 1. Reported orgasms
2. Mode of delivery
3. Recruitment to birth admission interval
4. Initial Bishop Score at the admission for birth
5. Pre-labour rupture of membranes
6. Use of dinoprostone
7. Use of oxytocin infusion during labour
8. Maternal fever
9. Epidural use in labour
10. Meconium stained liquor
11. Delivery blood loss
12. Neonatal admission
13. Apgar score at five minutes
14. Umbilical cord blood pH

Secondary outcomes are events during labour, at delivery or during the usually short hospital confinement after birth. No data is collected after hospital discharge.
Sources of funding University of Malaya (Malaysia)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17906015
Contact name Dr  Peng Chiong  Tan
  Address Department of Obstetrics & Gynaecology
University of Malaya
Lembah Pantai
  City/town Kuala Lumpur
  Zip/Postcode 50603
  Country Malaysia
Sponsor University of Malaya Medical Centre (Malaysia)
  Address Lembah Pantai
  City/town Kuala Lumpur
  Zip/Postcode 50603
  Country Malaysia
  Sponsor website: http://www.ummc.edu.my
Date applied 14/06/2007
Last edited 03/10/2007
Date ISRCTN assigned 26/06/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.