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NCT00740506 · ClinicalTrials.gov registry record · Phase 4

Behavioral and Environmetal Factors and Time to Delivery

A Phase 4 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
Phase 4
Development phase
510
Enrollment target

NCT00740506 is a Phase 4 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 510 participants.

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The verdict

NCT00740506, a Phase 4 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
Phase 4
Development phase
510 participants
Enrollment target

Study 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.

Interventions

  • BEHAVIORAL Frequency of Intercourse

Trial Details

FieldValue
Enrollment Target 510 participants
Start Date 2008-08-20
Est. Completion 2009-07-13
Phase Phase 4

What the Registry Record Tells You About NCT00740506

The ClinicalTrials.gov registry entry for NCT00740506 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Frequency of Intercourse is the first listed.

NCT00740506 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00740506 about?

NCT00740506 is a clinical study titled "Behavioral and Environmetal Factors and Time to Delivery". 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. Alt...

What is the current status of trial NCT00740506?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 510 participants. The study started on 2008-08-20. Estimated completion is 2009-07-13.

What interventions are being tested in trial NCT00740506?

The interventions under investigation include: Frequency of Intercourse (BEHAVIORAL).

Who is sponsoring clinical trial NCT00740506?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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