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

NCT00872040 | Unknown

• 1 other identifier: SHEBA-09-5177-MA-CTIL
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Sexual function; Pelvic floor disorders; Delivery mode

Study Arms (1)

Nuliparous women and their husbands

Women in their first pregnancy with their husbands

Other: Ultrasound assessment of pelvic floor

Interventions

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.

Also known as: Ultrasound examination of pelvic floor

Nuliparous women and their husbands

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who attend primary care antenatal clinic

You may qualify if:

• Pregnant women in their 1st pregnancy
• Married couples in their 1st marriage

You may not qualify if:

• Chronic GIT disease
• Endometriosis
• Chronic GUT disease
• Psychiatric disease
• Known sexual dysfunction

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Antenatal primary care clinic

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Oria Tishbi, PhD

  School of Social Work, Hebrew University, Jerusalem

  STUDY CHAIR

Central Study Contacts

Sari Lavee, MSc

CONTACT

dlavee@zahav.net.il

Menachem Alcalay, MD

CONTACT

malcalay@netvison.net.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: March 31, 2009

Record last verified: 2009-03

Locations

IL (1)