NCT01753258|Completed
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Sponsor study identifier
observational
173
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)The focus of this pilot study is to determine if a woman who experiences pain during sexual intercourse has a higher risk of complications during labor and delivery secondary to pelvic floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is unclear whether women with prepartum dyspareunia experience an improvement following vaginal delivery. While physicians may expect that vaginal birth improves dyspareunia due to the stretching effect on pelvic floor, to date, there is insufficient evidence to support this claim. The Investigators plan to prospectively study 200 patients at our Institution, collect information regarding birth and follow them, via questionnaires, regarding their dyspareunia postpartum.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2012
Actual (reported)December 20, 2012
Actual (reported)January 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 2016
Actual (reported)September 2016
Actual (reported)Obstetrical outcome of women with a history of dyspareunia
The Investigators will record the mode of delivery (vaginal, instrumental or cesarean section), length of the second stage of labor, use of anesthetics, perineal tears and\\or episiotomies, and newborn's birth weight. The evaluation will be done prospectively, comparing data with matched controls without a history of dyspareunia.
3 months -1 year
Rate of alleviation of dyspareunia following vaginal delivery as assessed through patient questionnaires.
2 years
Patients who report dyspareunia, and whose dyspareunia was evaluated prior to delivery by a caregiver experienced with sexual pain disorders, with definite diagnosis.
Patients who report dyspareunia but were not evaluated prior to delivery or were evaluated inappropriately (i.e. "yeast infection" without cultures, "inflammation" and other vague definitions).
Patients without dyspareunia- those who report non painful sexual intercourse. This group of patients will be used as a control group.
Nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18
Hadassah Medical Organization
Jerusalem, Israel
Ahinoam Lev-Sagie, MD
Hadassah Medical Organization
173 participants (actual enrollment reported by the registry).
First Submitted
December 12, 2012
First Posted
December 20, 2012
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Performance Evaluation Study for a New Meconium Detection Test
Contact the study team to confirm eligibility.
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)Last Updated
October 11, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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