The Effect of Delivery Mode on Inter - Couple Relationshi... | NCT00872040

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

NCT00872040

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Mar 31, 2009Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Pregnancy

Interventions

Ultrasound assessment of pelvic floor

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Oct 2010Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

Mar 30, 2009

First Submission Date that Met QC Criteria

Mar 30, 2009

First Posted Date

Mar 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2009

Last Update Posted Date

Mar 31, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nuliparous women and their husbands		Women in their first pregnancy with their husbands	Other: Ultrasound assessment of pelvic floor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound assessment of pelvic floor	Other	Sample of women will undergo ultrasound examination of their pelvic floor before and after delivery. The assessment will be performed by transperineal probe.

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women who attend primary care antenatal clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sari Lavee, MSc	Contact			dlavee@zahav.net.il
Menachem Alcalay, MD	Contact			malcalay@netvison.net.il

Overall Officials

Name	Affiliation	Role
Oria Tishbi, PhD	School of Social Work, Hebrew University, Jerusalem	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antenatal primary care clinic	Recruiting	Kfar Saba			Israel

Condition Browse Module

MeSH Terms

ID	Term
D059952	Pelvic Floor Disorders

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D011248	Pregnancy Complications

Browse Leaves

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Browse Branches

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