Randomised Controlled Trial of the effect of Advice On Sexual Intercourse after 36 weeks on pregnancy duration and the rate of induction of labour thereafter

ISRCTN	ISRCTN82333699
DOI	https://doi.org/10.1186/ISRCTN82333699
Protocol serial number	N/A
Sponsor	University of Malaya Medical Centre (Malaysia)
Funder	University of Malaya Medical Centre (Malaysia)

Submission date: 19/08/2007
Registration date: 11/09/2007
Last edited: 15/03/2013

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 Nada Sabir
Scientific

B1206 University Towers
No.28, Section 11
Petaling Jaya
Selangor
46200
Malaysia

Phone	+60 (0)1 2359 3272
Email	nada_sabir@yahoo.co.uk

Study information

Primary study design	Interventional
Study design	Single-centre, single-blind, randomised controlled trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	RCTAOSI
Study objectives	Current evidences suggest that sexual intercourse has a role in promoting labour. All mentioned evidences are based on prospective observational studies and it is unknown at present whether advice on sexual intercourse at 36 weeks would be of value in initiation of labour. Hence, we propose an interventional study: a randomised controlled trial to study the effect of advising or encouraging sexual intercourse after 36 weeks gestation to ascertain the effect of the intervention on the primary outcomes of: 1. Actual frequency of sexual activity 2. Duration of pregnancy 3. Requirement of induction of labour for prolonged pregnancy
Ethics approval(s)	Ethics approval received from the Medical Ethics Committee of University of Malaya Medical Centre on the 16th August 2006 (ref: 523.3).
Health condition(s) or problem(s) studied	Pregnancy
Intervention	Advice on sexual intercourse versus usual care only.
Intervention type	Other
Primary outcome measure(s)	1. Duration of pregnancy 2. Rate of induction of labour
Key secondary outcome measure(s)	1. Hospital admissions since randomisation 2. Length of gestation 3. Prelabour rupture of membranes (PROM) 4. Method of labour induction (if any) 5. Indication for labour induction 6. Length of labour 7. Epidural use in labour 8. Oxytocin augmentation 9. Mode of delivery 10. Indications for operative delivery 11. Endometritis 12. Maternal hospital stay 13. Apgar score 14. Cord pH at birth 15. Admission to the neonatal unit 16. Indication for neonatal admission
Completion date	01/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1623
Key inclusion criteria	Women attending University Malaya Medical Centre (UMMC) antenatal clinic at 35 weeks gestation will be approached to enter the study. Women who have not been sexually active in the last 6 weeks will be eligible for trial entry.
Key exclusion criteria	1. Placenta praevia 2. Antepartum haemorrhage 3. Ruptured membranes 4. Previous caesarean 5. Hypertension 6. Diabetes 7. Growth restricted baby 8. Multiple gestations 9. Previous stillbirth 10. Foetal anomalies
Date of first enrolment	01/09/2007
Date of final enrolment	01/09/2009

Locations

Countries of recruitment

Malaysia

Study participating centre

B1206 University Towers

Selangor
46200
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes