Condition category
Pregnancy and Childbirth
Date applied
19/08/2007
Date assigned
11/09/2007
Last edited
15/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.um.edu.my

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

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23145957

Publication citations

  1. 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.

Additional files

Editorial Notes