- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00872040
The Effect of Delivery Mode on Inter - Couple Relationship, Sexual Function and Pelvic Floor Activity
March 30, 2009 updated by: Sheba Medical Center
Observational Study on the Effect of Delivery Mode on Inter Personal Relationship, Sexual Function and Pelvic Floor Activity
Pregnancy and delivery have a major impact on couple's inter personal relationship.
Different modes of delivery have different effect on pelvic floor function, and it is known that instrumental vaginal deliveries have the worse effect, though various common anatomical injuries have been described following vaginal delivery.
Pelvic floor dysfunction has the potential to ameliorate sexual function, and the investigators hypothesis is that the impact of delivery on pelvic floor disorders following delivery will have a direct effect on sexual malfunction and interpersonal relationship.
The purpose of this study is to evaluate the effect of delivery mode of primiparous women on inter couple relationship , their sexual function and the female pelvic floor activity.
The couples will be followed from the second trimester of the pregnancy by validated specific questionnaires, assessing the couple's satisfaction of their marriage, intimacy in their relationship, their sexual behavior and pelvic floor function.
After delivery, the parameters of the parturition will be recorded, and the couples will be interviewed 6 months following delivery.
Apart from questionnaires, sample of the participated women will be assessed by ultrasound examination of the pelvic floor.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Pregnant women in their first pregnancy and their husbands will be recruited from 14th week of gestation.
The couples will be followed by validated specific questionnaires, such as Couple Satisfaction Index (CSI), Isreali Sexual Behavior Inventory (ISBI), Pelvic Floor Distress Inventory (PFDI)and Pelvic Floor Impact Questionnaire (PFIQ) assessing the couple's satisfaction of their marriage, intimacy in their relationship, their sexual behavior and pelvic floor function.
After delivery, the parameters of the parturition will be recorded, and the couples will be interviewed 6 months following delivery.
Apart from questionnaires, sample of the participated women will be assessed by ultrasound examination of the pelvic floor, demonstrating the continuity of pelvic floor muscles and their function.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kfar Saba, Israel
- Recruiting
- Antenatal primary care clinic
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Contact:
- Sari Lavee, MSc
- Email: dlavee@zahav.net.il
-
Contact:
- Menachem Alcalay, MD
- Email: malcalay@netvision.net.il
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Sub-Investigator:
- Sari Lavee, MSc
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Women who attend primary care antenatal clinic
Description
Inclusion Criteria:
- Pregnant women in their 1st pregnancy
- Married couples in their 1st marriage
Exclusion Criteria:
- Chronic GIT disease
- Endometriosis
- Chronic GUT disease
- Psychiatric disease
- Known sexual dysfunction
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Nuliparous women and their husbands
Women in their first pregnancy with their husbands
|
Sample of women will undergo ultrasound examination of their pelvic floor before and after delivery.
The assessment will be performed by transperineal probe.
Other Names:
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Oria Tishbi, PhD, School of Social Work, Hebrew University, Jerusalem
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
October 1, 2008
Primary Completion (Anticipated)
October 1, 2010
Study Completion (Anticipated)
October 1, 2011
Study Registration Dates
First Submitted
March 30, 2009
First Submitted That Met QC Criteria
March 30, 2009
First Posted (Estimate)
March 31, 2009
Study Record Updates
Last Update Posted (Estimate)
March 31, 2009
Last Update Submitted That Met QC Criteria
March 30, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- SHEBA-09-5177-MA-CTIL
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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