Child AbuseCSA-V-LDNCT01530113
Childhood Sexual Abuse, Vaginismus and Labor Dystocia
An observational study of Child Abuse and Vaginismus, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Abuse, Vaginismus, Dystocia
- How many people
- 2,000 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women in their third trimester
Who may be able to join
- pregnant women in their third trimester
Who cannot join
- alcohol addiction
- drug addiction
- mental retardation
- active psychopathology
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
Hadera, 38100
Mordechai Hallak, M.D, Prof.
About this study
Official title: 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:
Read more
- 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.
Read the 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:
- providing a developing theory for evidence-based practice.
- 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.
- 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.
- Conditions
- Child Abuse, Vaginismus, Dystocia, Depression
- Keywords
- Childhood sexual abuse, Vaginismus, Partial vaginismus, Labor dystocia, Depression
- Medical subject headings
- Vaginismus, Dystocia, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- The Baruch Padeh Medical Center, Poriya
- Responsible party
- Sponsor
- Investigators
- Mordechai Hallak, M.D, Prof., Principal investigator, Hillel Yaffe Medical CenterRachel Lev-Wiesel, Ph.D, Prof., Principal investigator, Haifa UniversityHila Sharabi, M.D, Study director, Hillel Yaffe Medical CenterRuth Gottfried, Ph.D Student, Study director, Haifa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530113
- Sponsor's protocol ID
- -0085-11
- Acronym
- CSA-V-LD
- Status last verified
- Jan 2012
- First submitted
- 25 Jan 2012
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Sexual Abuse, Vaginismus and Labor Dystocia: Towards a Theoretical Model
- ClinicalTrials.gov ID
- NCT01530113
- Acronym / sponsor ID
- CSA-V-LD / -0085-11
- Conditions
- Child Abuse, Vaginismus, Dystocia, Depression
- Keywords
- Childhood sexual abuse, Vaginismus, Partial vaginismus, Labor dystocia, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- The Baruch Padeh Medical Center, Poriya
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 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:
- providing a developing theory for evidence-based practice.
- 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.
- 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
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women in their third trimester
Key inclusion criteria (1 listed)
- pregnant women in their third trimester
Key exclusion criteria (4 listed)
- alcohol addiction
- drug addiction
- mental retardation
- active psychopathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mordechai Hallak, M.D, Prof. principal investigator
Hillel Yaffe Medical Center
Rachel Lev-Wiesel, Ph.D, Prof. principal investigator
Haifa University
Hila Sharabi, M.D study director
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Abuse and Vaginismus, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mordechai Hallak, M.D, Prof. (972-4-6304244, mottih@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.