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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01753258
Other study ID # Delivery-Dyspareunia-HMO-CTIL
Secondary ID
Status Completed
Phase N/A
First received December 12, 2012
Last updated October 10, 2016
Start date January 2013
Est. completion date September 2016

Study information

Verified date October 2016
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 173
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Rate of alleviation of dyspareunia following vaginal delivery as assessed through patient questionnaires. 2 years No
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