NCT01907698

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

2.2 years

First QC Date

July 5, 2013

Last Update Submit

July 22, 2013

Conditions

Keywords

vaginal intercourselabourterm pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Gestational age at delivery

    Gestational age at delivery (between 37 and 42 weeks of pregnancy)

  • Mode of delivery

    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 (maximum period of 28 days - between 38 and 41/0-6 weeks/days of pregnancy)

Study Arms (2)

Vaginal coitus group

Pregnant women assigned to have vaginal coitus at least twice a week

Behavioral: Vaginal intercourse

Control group

Pregnant women assigned to have no vaginal intercourse

Interventions

vaginal intercourse at least twice a week

Vaginal coitus group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women attending to antenatal appointment in our Obstetric Unit

You may qualify if:

  • Term pregnancy
  • Singleton pregnancy
  • Cephalic presentation
  • No previous cesarean section
  • Irrelevant obstetric history
  • Surveiled pregnancy without complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Santa Maria

Lisbon, Portugal

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coitus

Interventions

Sex

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Catarina Castro, Dr

    Hospital de Santa Maria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 5, 2013

First Posted

July 25, 2013

Study Start

April 1, 2009

Primary Completion

June 1, 2011

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations