Outcomes of Delivery in Patients With Dyspareunia

Pregnancy Clinical Trial

Official title:

Outcomes of Delivery in Patients With Dyspareunia- A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753258
• Other study ID #: Delivery-Dyspareunia-HMO-CTIL
• 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

Related Conditions & MeSH terms

• Dyspareunia
• Pelvic Floor Dysfunction
• Pregnancy
• Provoked Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

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