NCT03953573

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

May 15, 2019

Last Update Submit

March 15, 2021

Conditions

SexualityDelivery

Outcome Measures

Primary Outcomes (1)

  • Post-delivery sexuality resumption

    Time to sexuality resumption

    3 months

Secondary Outcomes (3)

  • Discussion with healthcare professional on post-delivery sexuality

    1 month

  • Pain post-delivery

    3 months

  • Sexual health

    3 months

Study Arms (1)

Women post-delivery

Other: Survey

Interventions

SurveyOTHER

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

Women post-delivery

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Primiparous women, delivery at hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, France

Location

MeSH Terms

Conditions

Sexuality

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 16, 2019

Study Start

December 22, 2018

Primary Completion

December 8, 2020

Study Completion

December 8, 2020

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)