Spontaneous Labour OnsetNCT01907698
Effect of Vaginal Intercourse on Spontaneous Labour at Term
An observational study of Spontaneous Labour Onset and Vaginal Intercourse at Term, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spontaneous Labour Onset, Vaginal Intercourse at Term
- What is being tested?
- Vaginal intercourse
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 123 participants
- Where
- 1 sitePortugal
- Study dates
- Apr 2009to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women attending to antenatal appointment in our Obstetric Unit
Who may be able to join
- Term pregnancy
- Singleton pregnancy
- Cephalic presentation
- No previous cesarean section
- Irrelevant obstetric history
- Surveiled pregnancy without complications
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vaginal Intercourse on Spontaneous Labour at Term- A Randomized Trial
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.
- Being tested
- Vaginal intercourse
- Keywords
- vaginal intercourse, labour, term pregnancy
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal intercourseBehavioural
vaginal intercourse at least twice a week
| Study group | Role | What they receive |
|---|---|---|
| Vaginal coitus group | Pregnant women assigned to have vaginal coitus at least twice a week Receives: Behavioral: Vaginal intercourse | |
| Control group | Pregnant women assigned to have no vaginal intercourse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous labour onset at term
Spontaneous labour was considered to be established when there were regular contractions and at least 3cm of cervical dilation.
Measured: Spontaneous labour onset between 37 and 42 weeks of pregnancy
Secondary outcomes (3)
Gestational age at delivery
Measured: Gestational age at delivery (between 37 and 42 weeks of pregnancy)
Mode of delivery
Route of delivery - vaginally or cesarean
Measured: Mode of delivery (vaginal or cesarean delivery) up to 42 weeks of pregnancy
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)
Measured: number of days between patients study recruitment and delivery (maximum period of 28 days - between 38 and 41/0-6 weeks/days of pregnancy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startApr 2009
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Labour OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Santa Maria, Portugal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catarina Castro, Hospital de Santa Maria, Portugal
- Investigators
- Catarina Castro, Dr, Principal investigator, Hospital de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907698
- Sponsor's protocol ID
- Catarina Castro
- Status last verified
- Jul 2013
- First submitted
- 5 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castro C, Afonso M, Carvalho R, Clode N, Graca LM. Effect of vaginal intercourse on spontaneous labor at term: a randomized controlled trial. Arch Gynecol Obstet. 2014 Dec;290(6):1121-5. doi: 10.1007/s00404-014-3343-0. Epub 2014 Jul 18.
PubMed 25033717
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vaginal Intercourse on Spontaneous Labour at Term- A Randomized Trial
- ClinicalTrials.gov ID
- NCT01907698
- Acronym / sponsor ID
- Catarina Castro
- Keywords
- vaginal intercourse, labour, term pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hospital de Santa Maria, PortugalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal coitus group | – | Behavioral: Vaginal intercoursePregnant women assigned to have vaginal coitus at least twice a week |
| Control group | – | –Pregnant women assigned to have no vaginal intercourse |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women attending to antenatal appointment in our Obstetric Unit
Key inclusion criteria (6 listed)
- Term pregnancy
- Singleton pregnancy
- Cephalic presentation
- No previous cesarean section
- Irrelevant obstetric history
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal intercoursevaginal intercourse at least twice a week | Behavioural | Vaginal coitus group |
Primary outcome
Spontaneous labour onset at term
Time frame: Spontaneous labour onset between 37 and 42 weeks of pregnancy
Spontaneous labour was considered to be established when there were regular contractions and at least 3cm of cervical dilation.
3 secondary outcomes
Gestational age at delivery
Time frame: Gestational age at delivery (between 37 and 42 weeks of pregnancy)
Mode of delivery
Time frame: Mode of delivery (vaginal or cesarean delivery) up to 42 weeks of pregnancy
Interval between recruitment and delivery
Time frame: number of days between patients study recruitment and delivery (maximum period of 28 days - between 38 and 41/0-6 weeks/days of pregnancy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- Derived from this study: PubMed 25033717Castro C, Afonso M, Carvalho R, Clode N, Graca LM. Effect of vaginal intercourse on spontaneous labor at term: a randomized controlled trial. Arch Gynecol Obstet. 2014 Dec;290(6):1121-5. doi: 10.1007/s00404-014-3343-0. Epub 2014 Jul 18.
Related trials for Spontaneous Labour Onset
Recruiting
The SWEEP Trial: a Randomized Controlled Trial
Membrane Stripping, Cervical Ripening
Not yet recruiting
To Compare Sweeping of Membranes Versus Expectant Management for Spontaneous Onset of Labor and Vaginal Delivery.
Post-Term Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina Castro, Dr principal investigator
Hospital de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Labour Onset and Vaginal Intercourse at Term, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous labour onset at term (time frame: Spontaneous labour onset between 37 and 42 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01907698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.