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Childhood Sexual Abuse, Vaginismus and Labor Dystocia (CSA-V-LD)

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ClinicalTrials.gov Identifier: NCT01530113
Recruitment Status : Unknown
Verified January 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 9, 2012
Last Update Posted : February 9, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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:

  1. 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.
  2. D will serve as a mediator between prenatal PV and LD.
  3. PV will serve as a risk factor for LD.
  4. postpartum PV will be affected by childbirth (LD vs. no LD) contingent on the level of D.

Condition or disease
Child Abuse Vaginismus Dystocia Depression

Detailed Description:

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.

The potential significance of the study is twofold: Theoretically, the study represents a first of its kind effort to explore the relationships between child sexual abuse, prenatal and postpartum partial vaginismus, childbirth and depression, in a single comprehensive longitudinal research study. Practically, the study may potentially assist a wide range of health care professionals by:

  1. providing a developing theory for evidence-based practice.
  2. showing the need for integration of women's past history into prenatal and postnatal care as a means of lowering the risk for a traumatic birth experience and later psychological distress.
  3. aiding in the development of intervention models for the treatment of women with a history of child sexual abuse and/or vaginismus during pregnancy and childbirth.

Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Official Title: Childhood Sexual Abuse, Vaginismus and Labor Dystocia: Towards a Theoretical Model
Study Start Date : March 2012
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women in their third trimester
Criteria

Inclusion Criteria:

  • pregnant women in their third trimester

Exclusion Criteria:

  • alcohol addiction
  • drug addiction
  • mental retardation
  • active psychopathology
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530113


Contacts
Contact: Mordechai Hallak, M.D, Prof. 972-4-6304244 mottih@hy.health.gov.il
Contact: Hila Sharabi, M.D 972-52-823-5268 drhilash@gmail.com

Locations
Israel
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: Mordechai Hallak, M.D, Prof.         
Sponsors and Collaborators
Hillel Yaffe Medical Center
The Baruch Padeh Medical Center, Poriya
Investigators
Principal Investigator: Mordechai Hallak, M.D, Prof. Hillel Yaffe Medical Center
Principal Investigator: Rachel Lev-Wiesel, Ph.D, Prof. Haifa University
Study Director: Hila Sharabi, M.D Hillel Yaffe Medical Center
Study Director: Ruth Gottfried, Ph.D Student Haifa University
More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01530113     History of Changes
Other Study ID Numbers: -0085-11
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: January 2012

Keywords provided by Hillel Yaffe Medical Center:
Childhood sexual abuse
Vaginismus
Partial vaginismus
Labor dystocia
Depression

Additional relevant MeSH terms:
Depression
Dystocia
Vaginismus
Behavioral Symptoms
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Female
Vaginal Diseases
Sexual Dysfunctions, Psychological
Mental Disorders