The Effect of Delivery Mode on Inter - Couple Relationship, Sexual Function and Pelvic Floor Activity
Recruitment status was Recruiting
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 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|
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872040
|Contact: Sari Lavee, MScemail@example.com|
|Contact: Menachem Alcalay, MDfirstname.lastname@example.org|
|Antenatal primary care clinic||Recruiting|
|Kfar Saba, Israel|
|Contact: Sari Lavee, MSc email@example.com|
|Contact: Menachem Alcalay, MD firstname.lastname@example.org|
|Sub-Investigator: Sari Lavee, MSc|
|Study Chair:||Oria Tishbi, PhD||School of Social Work, Hebrew University, Jerusalem|