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NCT03953573 Clinical Trial

Management of Post-delivery Pain and Its Impact on Resumption of Sexuality

Sexuality Clinical Trial

— SMD  

Official title:
Management of Post-delivery Pain and Its Impact on Resumption of Sexuality

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03953573
Other study ID # 2018_0057
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 22, 2018
Est. completion date December 8, 2020

Study information
Verified date March 2021
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study of management of pain and information given to women post-delivery and their impact of the resumption of sexuality. Survey to be completed by women at 8 and 15 days and 1 or 3 months after delivery.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date December 8, 2020
Est. primary completion date December 8, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Primiparous woman - Age between 18 and 45 years old - Delivery after 37 weeks of amenorrhea - Speaking French - Pregnancy, delivery and new-born examination without morphologic or biometric abnormalities, respiratory distress and no pathology discovered at neonatal screening on day 3 - Heterosexual woman with partner - Signed consent - Affiliate of national health insurance scheme Exclusion Criteria: - Multiple pregnancy, - BMI > 30 - Conjugopathie - Known psychiatric history - Medical history with gynecologic impact - Surgery history with gynecologic impacts - Hysterectomy post-delivery - Protected by French law

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Survey
Survey completed at 1 day, 8 days 1 or 3 months post delivery

Locations
Country Name City State
France Hopital Foch Suresnes

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-delivery sexuality resumption Time to sexuality resumption 3 months
Secondary Discussion with healthcare professional on post-delivery sexuality Number of women receiving advice from a health professional 1 month
Secondary Pain post-delivery Number of women needed pain treatment or with problem for sexuality resumption 3 months
Secondary Sexual health Frequency of sex 3 months
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