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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03953573
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Study Description
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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.


Condition or disease Intervention/treatment
Sexuality Delivery Other: Survey

Study Design
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Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Post-delivery Pain and Its Impact on Resumption of Sexuality
Actual Study Start Date : December 22, 2018
Actual Primary Completion Date : December 8, 2020
Actual Study Completion Date : December 8, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Women post-delivery Other: Survey
Survey completed at 1 day, 8 days 1 or 3 months post delivery


Outcome Measures
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Primary Outcome Measures :
  1. Post-delivery sexuality resumption [ Time Frame: 3 months ]
    Time to sexuality resumption


Secondary Outcome Measures :
  1. Discussion with healthcare professional on post-delivery sexuality [ Time Frame: 1 month ]
    Number of women receiving advice from a health professional

  2. Pain post-delivery [ Time Frame: 3 months ]
    Number of women needed pain treatment or with problem for sexuality resumption

  3. Sexual health [ Time Frame: 3 months ]
    Frequency of sex


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primiparous women, delivery at hospital.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953573


Locations
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France
Hopital Foch
Suresnes, France
Sponsors and Collaborators
Hopital Foch
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03953573    
Other Study ID Numbers: 2018_0057
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No