Outcomes of Delivery in Patients With Dyspareunia
This study is not yet open for participant recruitment.
Verified December 2012 by Hadassah Medical Organization
Sponsor:
Hadassah Medical Organization
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
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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 |
|---|
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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 |
|---|
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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.
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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).
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Patients without dyspareunia
Patients without dyspareunia- those who report non painful sexual intercourse. This group of patients will be used as a control group.
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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:
- 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
Contacts and Locations
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 May 23, 2013