Outcomes of Delivery in Patients With Dyspareunia

Outcomes of Delivery in Patients With Dyspareunia- A Prospective Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01753258

Enrollment

173

Registered

2012-12-20

Start date

2013-01-31

Completion date

2016-09-30

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspareunia, Pelvic Floor Dysfunction, Pregnancy, Provoked Vestibulodynia

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Obstetrical outcome of women with a history of dyspareunia	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

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

Countries

Israel

Outcome results