Contact information
Type
Scientific
Primary contact
Dr Nada Sabir
ORCID ID
Contact details
B1206 University Towers
No.28
Section 11
Petaling Jaya
Selangor
46200
Malaysia
+60 (0)1 2359 3272
nada_sabir@yahoo.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
RCTAOSI
Study hypothesis
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
Ethics approval received from the Medical Ethics Committee of University of Malaya Medical Centre on the 16th August 2006 (ref: 523.3).
Study design
Single-centre, single-blind, randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy
Intervention
Advice on sexual intercourse versus usual care only.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Duration of pregnancy
2. Rate of induction of labour
Secondary outcome measures
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
Overall trial start date
01/09/2007
Overall trial end date
01/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1623
Participant 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
Recruitment start date
01/09/2007
Recruitment end date
01/09/2009
Locations
Countries of recruitment
Malaysia
Trial participating centre
B1206 University Towers
Selangor
46200
Malaysia
Sponsor information
Organisation
University of Malaya Medical Centre (Malaysia)
Sponsor details
50603
Kuala Lumpur
50603
Malaysia
+60 (0)3 7949 2472
sitizawiah@um.edu.my
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Malaya Medical Centre (Malaysia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23145957
Publication citations
-
Results
Omar NS, Tan PC, Sabir N, Yusop ES, Omar SZ, Coitus to expedite the onset of labour: a randomised trial., BJOG, 2013, 120, 3, 338-345, doi: 10.1111/1471-0528.12054.