Clinical trial NCT00872040: The Effect of Delivery Mode on Inter - Couple Relationship, Sexual Function and Pelvic Floor Activity
Official title: Observational Study on the Effect of Delivery Mode on Inter Personal Relationship, Sexual Function and Pelvic Floor Activity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Sexual function
Pelvic floor disorders
Delivery mode
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who attend primary care antenatal clinic

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Antenatal primary care clinic
Study officials:
affiliation: School of Social Work, Hebrew University, Jerusalem
name: Oria Tishbi, PhD
role: STUDY_CHAIR
References: