Outcomes of Delivery in Patients With Dyspareunia

Completed

• Conditions: Provoked Vestibulodynia; Pregnancy; Pelvic Floor Dysfunction; Dyspareunia

• Registration Number: NCT01753258
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Study Start: 2013-01
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 173

Inclusion Criteria

1. 200 nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18.
2. Able and willing to read, understand, and sign the Informed Consent Form and questionnaire.
3. Agree to be contacted in the future to complete telephone questionnaires.

Exclusion Criteria

1. Induction of labor
2. Placental abruption, placenta previa
3. Malpresentation
4. Non reassuring fetal heart rate upon admission
5. Any other contraindication for vaginal delivery
6. Multifetal pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obstetrical outcome of women with a history of dyspareunia	3 months -1 year	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.

Secondary Outcome Measures

Name	Time	Method
Rate of alleviation of dyspareunia following vaginal delivery as assessed through patient questionnaires.	2 years

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel