Management of Post-delivery Pain and Its Impact on Resump... | NCT03953573

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

NCT03953573

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Mar 16, 2021Actual

Enrollment

105Actual

Phase

Not provided

Conditions

Sexuality
Delivery

Interventions

Survey

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2018Actual

Primary Completion Date

Dec 8, 2020Actual

Completion Date

Dec 8, 2020Actual

First Submitted Date

May 15, 2019

First Submission Date that Met QC Criteria

May 15, 2019

First Posted Date

May 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2021

Last Update Posted Date

Mar 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women post-delivery			Other: Survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	Survey completed at 1 day, 8 days 1 or 3 months post delivery	Women post-delivery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-delivery sexuality resumption	Time to sexuality resumption	3 months

Secondary Outcomes

Measure	Description	Time Frame
Discussion with healthcare professional on post-delivery sexuality	Number of women receiving advice from a health professional	1 month
Pain post-delivery	Number of women needed pain treatment or with problem for sexuality resumption

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Primiparous women, delivery at hospital.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D019529	Sexuality

ID	Term
D012725	Sexual Behavior
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided