Spontaneous Labour Onset Clinical Trial
Official title:
Effect of Vaginal Intercourse on Spontaneous Labour at Term- A Randomized Trial
| NCT number | NCT01907698 |
| Other study ID # | Catarina Castro |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | July 5, 2013 |
| Last updated | July 22, 2013 |
| Start date | April 2009 |
Vaginal intercourse to promote labour onset is biologically plausible. Oxytocin release during female orgasm, cervix mechanical stimulation and the effect of semen's prostaglandins are possible involved mechanisms. The investigators propose to evaluate the effect of vaginal intercourse on spontaneous labour at term.
| Status | Completed |
| Enrollment | 123 |
| Est. completion date | |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Term pregnancy - Singleton pregnancy - Cephalic presentation - No previous cesarean section - Irrelevant obstetric history - Surveiled pregnancy without complications |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Portugal | Hospital de Santa Maria | Lisbon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital de Santa Maria, Portugal |
Portugal,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Spontaneous labour onset at term | Spontaneous labour was considered to be established when there were regular contractions and at least 3cm of cervical dilation. | Spontaneous labour onset between 37 and 42 weeks of pregnancy | No |
| Secondary | Gestational age at delivery | Gestational age at delivery (between 37 and 42 weeks of pregnancy) | No | |
| Secondary | Mode of delivery | Route of delivery - vaginally or cesarean | Mode of delivery (vaginal or cesarean delivery) up to 42 weeks of pregnancy | No |
| Secondary | Interval between recruitment and delivery | number of days between patients study recruitment and delivery (patients were included in the study at 38 weeks of pregnancy and followed until delivery; if spontaneous labour did not occur labour induction was scheduled during the 41th week of pregnancy) | number of days between patients study recruitment and delivery (maximum period of 28 days - between 38 and 41/0-6 weeks/days of pregnancy) | No |