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

NCT ID: NCT00872040

Last Updated: 2009-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Keywords

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Sexual function Pelvic floor disorders Delivery mode

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nuliparous women and their husbands

Women in their first pregnancy with their husbands

Ultrasound assessment of pelvic floor

Intervention Type OTHER

Sample of women will undergo ultrasound examination of their pelvic floor before and after delivery. The assessment will be performed by transperineal probe.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Ultrasound examination of pelvic floor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chaim Sheba Medical Center

Principal Investigators

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Oria Tishbi, PhD

Role: STUDY_CHAIR

School of Social Work, Hebrew University, Jerusalem

Locations

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Antenatal primary care clinic

Kfar Saba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Sari Lavee, MSc

Role: CONTACT

Email: [email protected]

Menachem Alcalay, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Sari Lavee, MSc

Role: primary

Menachem Alcalay, MD

Role: backup

Other Identifiers

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SHEBA-09-5177-MA-CTIL

Identifier Type: -

Identifier Source: org_study_id