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

February 8, 2012 updated by: Hillel Yaffe Medical Center

Childhood Sexual Abuse, Vaginismus and Labor Dystocia: Towards a Theoretical Model

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
        • Principal Investigator:
          • Mordechai Hallak, M.D, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women in their third trimester

Description

Inclusion Criteria:

  • pregnant women in their third trimester

Exclusion Criteria:

  • alcohol addiction
  • drug addiction
  • mental retardation
  • active psychopathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • -0085-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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