Trial record 2 of 9 for:    Open Studies | "Dyspareunia"

Outcomes of Delivery in Patients With Dyspareunia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01753258
First received: December 12, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition
Dyspareunia
Pregnancy
Provoked Vestibulodynia
Pelvic Floor Dysfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Outcomes of Delivery in Patients With Dyspareunia- A Prospective Study

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Obstetrical outcome of women with a history of dyspareunia [ Time Frame: 3 months -1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Rate of alleviation of dyspareunia following vaginal delivery as assessed through patient questionnaires. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753258

Contacts
Contact: Ahinoam Lev-Sagie, MD 0097225844111 levsagie@netvision.net.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Ahinoam Lev-Sagie, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ahinoam Lev-Sagie, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01753258     History of Changes
Other Study ID Numbers: Delivery-Dyspareunia-HMO-CTIL
Study First Received: December 12, 2012
Last Updated: December 17, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Dyspareunia
Vulvodynia
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vulvar Diseases

ClinicalTrials.gov processed this record on July 20, 2014