Trial record 4 of 11 for:    Open Studies | "Child Abuse"

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

This study is not yet open for participant recruitment.
Verified January 2012 by Hillel Yaffe Medical Center
Sponsor:
Collaborator:
The Baruch Padeh Medical Center, Poriya
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01530113
First received: January 25, 2012
Last updated: February 8, 2012
Last verified: January 2012
  Purpose

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
Child Abuse
Vaginismus
Dystocia
Depression

Study Type: Observational
Official Title: Childhood Sexual Abuse, Vaginismus and Labor Dystocia: Towards a Theoretical Model

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Estimated Enrollment: 2000
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.
  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

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

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01530113     History of Changes
Other Study ID Numbers: -0085-11
Study First Received: January 25, 2012
Last Updated: February 8, 2012
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 17, 2014