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

• Conditions: Pregnancy
• Interventions: Other: Ultrasound assessment of pelvic floor

• Registration Number: NCT00872040
• Lead Sponsor: Sheba Medical Center

Brief 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.

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 Timeline

• Study Start: 2008-10
• Status Verified: 2009-03
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Last Update Submitted: 2009-03-30
• Study First Posted: 2009-03-31
• Last Update Posted: 2009-03-31
• Primary Completion: 2010-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nuliparous women and their husbands	Ultrasound assessment of pelvic floor	Women in their first pregnancy with their husbands

Trial Locations

Locations (1)

Antenatal primary care clinic; 🇮🇱 Kfar Saba, Israel