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

Pregnancy Clinical Trial

Official title:

Observational Study on the Effect of Delivery Mode on Inter Personal Relationship, Sexual Function and Pelvic Floor Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00872040
• Other study ID #: SHEBA-09-5177-MA-CTIL
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2009
• Last updated: March 30, 2009
• Start date: October 2008
• Est. completion date: October 2011

Study information

• Verified date: March 2009
• Source: Sheba Medical Center
• Contact: Sari Lavee, MSc
• Email: dlavee[@]zahav.net.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Israel	Antenatal primary care clinic	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel,