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NCT00740506

Behavioral and Environmetal Factors and Time to Delivery

Completed Phase 4 Last updated 2 July 2017
What this trial tests

Phase 4 trial testing Frequency of Intercourse in Pregnancy in 510 participants. Completed in 13 July 2009.

Timeline
20 August 2008
Primary endpoint
13 July 2009
13 July 2009

Quick facts

Lead sponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment510
Start date20 August 2008
Primary completion13 July 2009
Estimated completion13 July 2009
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who can join

Eligibility, female only, with Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Pregnancy

Currently open trials in the same condition.

Other Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) trials

Trials by the same sponsor.

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Data sources for this page

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