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The Effect of Delivery Mode on Inter - Couple Relationship, Sexual Function and Pelvic Floor Activity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00872040
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Pregnancy
 Other: Ultrasound assessment of pelvic floor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on the Effect of Delivery Mode on Inter Personal Relationship, Sexual Function and Pelvic Floor Activity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 300
Study Start Date: October 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nuliparous women and their husbands
Women in their first pregnancy with their husbands
 Other: Ultrasound assessment of pelvic floor
Sample of women will undergo ultrasound examination of their pelvic floor before and after delivery. The assessment will be performed by transperineal probe.
Other Name: Ultrasound examination of pelvic floor

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women who attend primary care antenatal clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872040

Contacts
Contact: Sari Lavee, MSc dlavee@zahav.net.il
Contact: Menachem Alcalay, MD malcalay@netvison.net.il

Locations
Israel
Antenatal primary care clinic Recruiting
Kfar Saba, Israel
Contact: Sari Lavee, MSc         dlavee@zahav.net.il    
Contact: Menachem Alcalay, MD         malcalay@netvision.net.il    
Sub-Investigator: Sari Lavee, MSc            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Chair: Oria Tishbi, PhD School of Social Work, Hebrew University, Jerusalem
  More Information

No publications provided

Responsible Party: Menachem Alcalay, Head - Urogynecology Service, Chaim Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00872040     History of Changes
Other Study ID Numbers: SHEBA-09-5177-MA-CTIL
Study First Received: March 30, 2009
Last Updated: March 30, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Sexual function
Pelvic floor disorders
Delivery mode

ClinicalTrials.gov processed this record on June 17, 2013