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
Secondary identifying numbers 492.7
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesPregnant 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) studiedPregnancy: labour induction
InterventionCounselling 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 typeOther
Primary outcome measure1. 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 measures1. 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.
Overall study start date01/12/2005
Completion date31/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants209
Key inclusion criteriaPregnant 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 criteria1. Previous caesarean section
2. Known gross foetal anomaly
Date of first enrolment01/12/2005
Date of final enrolment31/08/2007

Locations

Countries of recruitment

  • Malaysia

Study participating centre

Department of Obstetrics & Gynaecology
Kuala Lumpur
50603
Malaysia

Sponsor information

University of Malaya Medical Centre (Malaysia)
Hospital/treatment centre

Lembah Pantai
Kuala Lumpur
50603
Malaysia

http://www.ummc.edu.my
ROR logo https://ror.org/00vkrxq08

Funders

Funder type

University/education

University of Malaya (Malaysia)
Government organisation / Universities (academic only)
Alternative name(s)
University of Malaya, University Malaya, Malayan University, UM
Location
Malaysia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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