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
Secondary identifying numbers N/A
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

Study designSingle-centre, single-blind, randomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymRCTAOSI
Study objectivesCurrent 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) studiedPregnancy
InterventionAdvice on sexual intercourse versus usual care only.
Intervention typeOther
Primary outcome measure1. Duration of pregnancy
2. Rate of induction of labour
Secondary outcome measures1. 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
Overall study start date01/09/2007
Completion date01/09/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants1623
Key inclusion criteriaWomen 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 criteria1. 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 enrolment01/09/2007
Date of final enrolment01/09/2009

Locations

Countries of recruitment

  • Malaysia

Study participating centre

B1206 University Towers
Selangor
46200
Malaysia

Sponsor information

University of Malaya Medical Centre (Malaysia)
University/education

50603
Kuala Lumpur
50603
Malaysia

Phone +60 (0)3 7949 2472
Email sitizawiah@um.edu.my
Website http://www.um.edu.my
ROR logo "ROR" https://ror.org/00vkrxq08

Funders

Funder type

University/education

University of Malaya Medical Centre (Malaysia)

No information available

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 01/02/2013 Yes No