NCT00740506

Brief Summary

This study, conducted at the Naval Medical Center in San Diego, CA, will determine if having vaginal intercourse in the last weeks of pregnancy decreases the risk of having a prolonged pregnancy. Pregnancies that continue beyond the due date may increase health risks for the mother and the baby. Although some believe that vaginal intercourse can help start labor in the last weeks of pregnancy, there is not proof that it works. Some studies showed that sexual intercourse helped and some that pregnancy lasted even longer for couples having sex. In addition to exploring the effect of sexual intercourse on time to delivery, this study will collect information that can be used in the future to predict when labor will naturally start and the risk for overdue pregnancies. Women 18 years of age and older in their first pregnancy who are carrying a single fetus with gestational age before 38 plus 6 weeks may be eligible for this study. Candidates must be living with their partner in a stable relationship. Participants are asked to have sexual intercourse about three times per week. They complete a diary in which they record the times they have intercourse and how they are feeling daily. The diaries are submitted by mail each week or at the doctor's or midwife's visit until delivery. The women have a pelvic exam and ultrasound and complete questionnaires about problems during pregnancy, overall well-being, attitude toward induction of labor, physical activity, body image during pregnancy, stress and social support, habits at home, and environmental conditions, such as weather.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
510

participants targeted

Target at P75+ for phase_4 pregnancy

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_4 pregnancy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2009

Completed
Last Updated

July 2, 2017

Status Verified

July 13, 2009

Enrollment Period

11 months

First QC Date

August 22, 2008

Last Update Submit

June 30, 2017

Conditions

Pregnancy

Keywords

BehavioralEnvironmentalDeliveryPregnancy

Outcome Measures

Primary Outcomes (1)

  • Time to delivery

Secondary Outcomes (1)

  • Rate of cesarean delivery

Interventions

Frequency of IntercourseBEHAVIORAL

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Singleton pregnancy
  • First birth
  • Gestational age before 38 plus 6 weeks

You may not qualify if:

  • ART (IVF or ICSI)
  • Maternal heart disease
  • Gestational Diabetes, mellitus on insulin or pills
  • Scheduled induction of labor or Cesarean section
  • Breech presentation
  • Placenta praevia
  • Vaginal bleeding after 14 weeks of pregnancy
  • Fetal growth restriction
  • Known fetal anomalies (chromosomal or structural)
  • Hospitalization after 14 weeks of pregnancy
  • Can read and understand English
  • Medical reasons for the patient not to have sex.
  • Women whose husband/partner is currently deployed or will be deployed within the next four weeks or have any contra-indication for vaginal intercourse will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center, San Diego

San Diego, California, 92134-5000, United States

Location

Related Publications (3)

  • Caughey AB, Washington AE, Laros RK Jr. Neonatal complications of term pregnancy: rates by gestational age increase in a continuous, not threshold, fashion. Am J Obstet Gynecol. 2005 Jan;192(1):185-90. doi: 10.1016/j.ajog.2004.06.068.

    PMID: 15672023BACKGROUND

  • Caughey AB, Musci TJ. Complications of term pregnancies beyond 37 weeks of gestation. Obstet Gynecol. 2004 Jan;103(1):57-62. doi: 10.1097/01.AOG.0000109216.24211.D4.

    PMID: 14704245BACKGROUND

  • Caughey AB, Stotland NE, Escobar GJ. What is the best measure of maternal complications of term pregnancy: ongoing pregnancies or pregnancies delivered? Am J Obstet Gynecol. 2003 Oct;189(4):1047-52. doi: 10.1067/s0002-9378(03)00897-4.

    PMID: 14586353BACKGROUND

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

August 20, 2008

Primary Completion

July 13, 2009

Study Completion

July 13, 2009

Last Updated

July 2, 2017

Record last verified: 2009-07-13

Locations

US(1)