Medical Termination of Pregnancy : Evaluation of Patients... | NCT04294212

Studies
Medical Termination of Pregnancy : Evaluation of Patients' Practices and Feelings in Brest Hospital

NCT04294212

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Mar 4, 2020Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Medical Termination of Pregnancy

Interventions

Not provided

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 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2020Actual

Primary Completion Date

Aug 10, 2020Estimated

Completion Date

Aug 10, 2020Estimated

First Submitted Date

Mar 2, 2020

First Submission Date that Met QC Criteria

Mar 2, 2020

First Posted Date

Mar 4, 2020Actual

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 2, 2020

Last Update Posted Date

Mar 4, 2020Actual

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

This study evaluate the feelings of patients about a medical termination of pregnancy that they experienced in Brest Hospital. Patients responded to an online questionnaire assessing their feelings at each stage of the medical termination process. Their answers were associated with their medical data.

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

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall satisfaction score	answers to a satisfaction questionnaire based on a numerical scale ranging from 0 (dissatisfaction) to 3 (satisfaction), then calculation of the overall score	One day

Secondary Outcomes

Measure	Description	Time Frame
satisfaction score by indicator	satisfaction questionnaire divided into several parts according to an indicator	One day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient having experienced a medical termination of pregnancy in Brest Hospital
Medical termination of pregnancy after 14 weeks
Induction for natural delivery
No opposition

Exclusion Criteria:

Medical termination of pregnancy before 14 weeks
Selective termination of pregnancy (multiple pregnancy)
Caesarean
Patient not speaking french
Patient's refusal

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all patients having experienced a medical termination of pregnancy in Brest Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne-Hélène Saliou	Contact	02-98-22-35-33		anne-helene.saliou@chu-brest.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest	Recruiting	Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available beginning two year and ending five years following the publication

Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

URL

Not provided