Effect of Vaginal Intercourse on Spontaneous Labour at Term

July 22, 2013 updated by: Catarina Castro, Hospital de Santa Maria, Portugal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal
        • Hospital de Santa Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women attending to antenatal appointment in our Obstetric Unit

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaginal coitus group
Pregnant women assigned to have vaginal coitus at least twice a week
Behavioral: Vaginal intercourse
vaginal intercourse at least twice a week
Control group
Pregnant women assigned to have no vaginal intercourse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Spontaneous labour onset between 37 and 42 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational age at delivery
Time Frame: Gestational age at delivery (between 37 and 42 weeks of pregnancy)
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
Route of delivery - vaginally or cesarean
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Santa Maria, Portugal

Investigators

  • Principal Investigator: Catarina Castro, Dr, Hospital de Santa Maria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 22, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 25, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Catarina Castro

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spontaneous Labour Onset

Clinical Trials on Vaginal intercourse

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe