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
Scientific
B1206 University Towers
No.28, Section 11
Petaling Jaya
Selangor
46200
Malaysia
| Phone | +60 (0)1 2359 3272 |
|---|---|
| nada_sabir@yahoo.co.uk |
Study information
| Study design | Single-centre, single-blind, randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2007 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
46200
Malaysia
Sponsor information
University of Malaya Medical Centre (Malaysia)
University/education
University/education
50603
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)3 7949 2472 |
|---|---|
| sitizawiah@um.edu.my | |
| Website | http://www.um.edu.my |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
