Outcomes of Delivery in Patients With Dyspareunia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Pelvic Floor Dysfunction Pregnancy Provoked Vestibulodynia Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Hadassah Medical Organization

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

200 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Obstetrical outcome of women with a history of dyspareunia

Time frame: 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 outcomes

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

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Outcomes of Delivery in Patients With Dyspareunia- A Prospective Study

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Dec 20, 2012
Registry last updated: Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed