Clinical Trial: Childhood Sexual Abuse, Vaginismus and Labor Dystocia
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational
Official Title: Childhood Sexual Abuse, Vaginismus and Labor Dystocia: Towards a Theoretical Model
Brief Summary:
The study aims to develop a theoretical model explicating the inter-relationships between Childhood Sexual Abuse (CSA), Partial Vaginismus (PV) and Labor Dystocia (LD), including their associations with Depression (D) as a mediating variable.
The following research hypotheses will be tested:
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CSA will serve as a risk factor for D, PV and LD.
- pregnant women with a history of CSA will have higher levels of D compared to pregnant women without a history of CSA.
- pregnant women with a history of CSA will have more PV compared to pregnant women without a history of CSA.
- pregnant women with a history of CSA will have higher levels of LD compared to pregnant women without a history of CSA.
- D will serve as a mediator between prenatal PV and LD.
- PV will serve as a risk factor for LD.
- postpartum PV will be affected by childbirth (LD vs. no LD) contingent on the level of D.
Detailed Summary:
Previous studies indicate that childhood sexual abuse has long term implications to women's psychological and physical well-being; among them, depression, a plethora of gynecological symptoms and labor dystocia. Literature in the field also suggests that childhood sexual abuse may be a contributing factor to total and/or partial vaginismus: psycho-sexual disorders associated with significant difficulty and pain during attempted penetration, pelvic examinations and/or sexual relations.
The proposed quantitative longitudinal study aims to develop a theoretical model explicating the relationships between: childhood sexual abuse, prenatal and postpartum partial vaginismus, and childbirth (labor dystocia versus no labor dystocia); including their associations with depression as a mediating variable. Questionnaire responses of pregnant women (Hebrew/Arabic speakers) from the Hillel-Yaffe medical center in Israel will be included in the study.
Data collection will be extended across three time periods: prenatal (third trimester of pregnancy), within one month postpartum, and approximately six months postpartum. Study questionnaires will probe participant's socio-demographic and gynecological history, traumatic life events, sexual experiences, level of depression, partial vaginismus and sexual distress and the objective and subjective severity of their childbirth experience.
Simulations for this project were carried out to help set statistical significance goals and to determine the sample size needed to achieve these goals. From these simulations, a sample size of N=2000 was determined to be adequate and cost effective, to determine standard deviations SD (defining confidence interval ±SD) of about 0.022 for the correlations.
Sponsor: Hillel Yaffe Medical Center
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Hillel Yaffe Medical Center
Dates:
Date Received: January 25, 2012
Date Started: March 2012
Date Completion: March 2015
Last Updated: February 8, 2012
Last Verified: January 2012
