Effect of coital activity on onset of labour in women scheduled for labour induction: a randomised controlled trial

ISRCTN	ISRCTN17998696
DOI	https://doi.org/10.1186/ISRCTN17998696
Protocol serial number	492.7
Sponsor	University of Malaya Medical Centre (Malaysia)
Funder	University of Malaya (Malaysia)

Submission date: 14/06/2007
Registration date: 26/06/2007
Last edited: 10/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peng Chiong Tan
Scientific

Department of Obstetrics & Gynaecology
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Ethics approval(s)	Medical Ethics Committee University Malaya Medical Centre, 15/03/2005, ref: HU-61/12/1-1
Health condition(s) or problem(s) studied	Pregnancy: labour induction
Intervention	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.
Intervention type	Other
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).
Key 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.
Completion date	31/08/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	209
Key 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
Key exclusion criteria	1. Previous caesarean section 2. Known gross foetal anomaly
Date of first enrolment	01/12/2005
Date of final enrolment	31/08/2007

Locations

Countries of recruitment

Malaysia

Study participating centre

Department of Obstetrics & Gynaecology

Kuala Lumpur
50603
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2007		Yes	No