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

Sponsor
Hopital Foch (Other)
Overall Status
Completed
CT.gov ID
NCT03953573
Collaborator
(none)
105
Enrollment
1
Location
23.6
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Other: Survey

Study Design

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 :
Dec 22, 2018
Actual Primary Completion Date :
Dec 8, 2020
Actual Study Completion Date :
Dec 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Women post-delivery

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

Outcome Measures

Primary Outcome Measures

  1. Post-delivery sexuality resumption [3 months]

    Time to sexuality resumption

Secondary Outcome Measures

  1. Discussion with healthcare professional on post-delivery sexuality [1 month]

    Number of women receiving advice from a health professional

  2. Pain post-delivery [3 months]

    Number of women needed pain treatment or with problem for sexuality resumption

  3. Sexual health [3 months]

    Frequency of sex

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Hopital Foch Suresnes France

Sponsors and Collaborators

  • Hopital Foch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT03953573
Other Study ID Numbers:
  • 2018_0057
First Posted:
May 16, 2019
Last Update Posted:
Mar 16, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 16, 2021