Outcomes of Delivery in Patients With Dyspareunia

NCT01753258 | Completed

• 1 other identifier: Delivery-Dyspareunia-HMO-CTIL
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspareunia; Pregnancy; Provoked Vestibulodynia; Pelvic Floor Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of alleviation of dyspareunia following vaginal delivery as assessed through patient questionnaires.

  2 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• Induction of labor
• Placental abruption, placenta previa
• Malpresentation
• Non reassuring fetal heart rate upon admission
• Any other contraindication for vaginal delivery
• Multifetal pregnancy

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Ahinoam Lev-Sagie, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 20, 2012
• Study Start: January 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-10

Locations

IL (1)