NCT03449355

Brief Summary

Pregnancy and delivery usually affect the general women's quality of life. Some studies have reported that sexual health may be affected by the mode of delivery. More than 70% of pregnant women prefer C-section due to several reasons point out the fear of pain and complications of vaginal delivery as the most common reasons. Aim of the work: To explore the relationship between quality of life and the possible sexual dysfunction after normal vaginal in comparison to cesarean section deliveries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

February 22, 2018

Last Update Submit

March 31, 2018

Conditions

Sexual Dysfunction and the Mode of Deliveries

Keywords

sexualitymode of deliveryquality of life

Outcome Measures

Primary Outcomes (1)

  • quality of life after delivery

    the amplitude of many changes occur during and after pregnancy, which affect physical, psychological and social health and generally women's quality of life

    one month

Secondary Outcomes (1)

  • the relationship between quality of life and sexual dysfunction after both modes delivery

    one month

Study Arms (2)

vaginal group

cesarean section group

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

primiparous women 6-12 months after deliveries either vaginal or cesarean section

You may qualify if:

  • Primiparas women who had been delivered by either vaginal or cesarean section about 6-12months.
  • All included women should be officially married

You may not qualify if:

  • Women with history of sexual dysfunction
  • Women with history of any pelvic surgery apart from Cesarean.
  • history of anti-depressive drug therapy.
  • history of genital prolapse
  • history of Diabetes mellitus
  • loss of any family member or unfaveorouble neonatal outcome or childdeath
  • Divorce experience
  • family problems and cases who were not interested in participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalSexuality

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesSexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

January 11, 2018

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 3, 2018

Record last verified: 2018-03

Locations

EG(1)