Outcomes of Delivery in Patients With Dyspareunia

Outcomes of Delivery in Patients With Dyspareunia- A Prospective Study

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Definite diagnosis of dyspareunia; Patients who report dyspareunia, and whose dyspareunia was evaluated prior to delivery by a caregiver experienced with sexual pain disorders, with definite diagnosis.
No definite diagnosis of dyspareunia; 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; Patients without dyspareunia- those who report non painful sexual intercourse. This group of patients will be used as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of alleviation of dyspareunia following vaginal delivery as assessed through patient questionnaires.	2 years

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (ESTIMATE): December 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Vulvar Diseases; Vulvitis; Vulvodynia; Vulvar Vestibulitis; Dyspareunia
• Other Study ID Numbers: Delivery-Dyspareunia-HMO-CTIL