NCT01530113

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:

  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 9, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

January 25, 2012

Last Update Submit

February 8, 2012

Conditions

Child AbuseVaginismusDystociaDepression

Keywords

Childhood sexual abuseVaginismusPartial vaginismusLabor dystociaDepression

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women in their third trimester

You may qualify if:

  • pregnant women in their third trimester

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

VaginismusDystociaDepression

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMental DisordersObstetric Labor ComplicationsPregnancy ComplicationsBehavioral SymptomsBehavior

Study Officials

  • Mordechai Hallak, M.D, Prof.

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

  • Rachel Lev-Wiesel, Ph.D, Prof.

    Haifa University

    PRINCIPAL INVESTIGATOR

  • Hila Sharabi, M.D

    Hillel Yaffe Medical Center

    STUDY DIRECTOR

  • Ruth Gottfried, Ph.D Student

    Haifa University

    STUDY DIRECTOR

Central Study Contacts

Mordechai Hallak, M.D, Prof.

CONTACT

972-4-6304244mottih@hy.health.gov.il

Hila Sharabi, M.D

CONTACT

972-52-823-5268drhilash@gmail.com

Study Design

Study Type
observational
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2012

First Posted

February 9, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

February 9, 2012

Record last verified: 2012-01

Locations

IL(1)