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

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ClinicalTrials.gov Identifier: NCT03953573
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Tracking Information
First Submitted Date May 15, 2019
First Posted Date May 16, 2019
Last Update Posted Date May 16, 2019
Actual Study Start Date December 22, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2019)
Post-delivery sexuality resumption [ Time Frame: 3 months ]
Time to sexuality resumption
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 15, 2019)
  • Discussion with healthcare professional on post-delivery sexuality [ Time Frame: 1 month ]
    Number of women receiving advice from a health professional
  • Pain post-delivery [ Time Frame: 3 months ]
    Number of women needed pain treatment or with problem for sexuality resumption
  • Sexual health [ Time Frame: 3 months ]
    Frequency of sex
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Management of Post-delivery Pain and Its Impact on Resumption of Sexuality
Official Title Management of Post-delivery Pain and Its Impact on Resumption of Sexuality
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primiparous women, delivery at hospital.
Condition
  • Sexuality
  • Delivery
Intervention Other: Survey
Survey completed at 1 day, 8 days 1 or 3 months post delivery
Study Groups/Cohorts Women post-delivery
Intervention: Other: Survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 15, 2019)
105
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Elisabeth Hulier-Ammar +33(0)146251175 drci-promotion@hopital-foch.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03953573
Other Study ID Numbers 2018_0057
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hopital Foch
Study Sponsor Hopital Foch
Collaborators Not Provided
Investigators Not Provided
PRS Account Hopital Foch
Verification Date May 2019