Abortions at Strasbourg University Hospitals | NCT04101175

Studies
Abortions at Strasbourg University Hospitals

NCT04101175

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Sep 24, 2019Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

First-trimester Pregnancy

Interventions

Evaluation of the procedure of abortion

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

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2019Estimated

Primary Completion Date

Sep 2019Estimated

Completion Date

Oct 2020Estimated

First Submitted Date

Jul 4, 2019

First Submission Date that Met QC Criteria

Sep 20, 2019

First Posted Date

Sep 24, 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

Sep 20, 2019

Last Update Posted Date

Sep 24, 2019Actual

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

The number of abortions in France and Strasbourg has been stable for several years. In 2017, 1847 were performed in the Gynecology-Obstetrics Department for 6146 deliveries (23% of all pregnancies). It therefore seems important to evaluate the professional practices, but also the experiences of the patients.

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Request for abortion		Patient in first trimester of pregnancy in request for abortion	Procedure: Evaluation of the procedure of abortion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evaluation of the procedure of abortion	Procedure	Observational study using questionnaires	Request for abortion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the investigator's professional practices regarding abortion, particularly in relation to the recommendations for clinical practice of the National College of French Obstetricians Gynecologists (CNGOF) published in 2016.	The patients will complete a questionnaire	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the sociological, economic and psychological factors motivating the request for abortion	The patients will complete a questionnaire	6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patient in the first trimester of pregnancy wishing an abortion
Age: greater than or equal to 18 years.
Patient affiliated to a social security system

Exclusion criteria:

Patient after the first trimester pregnancy
Patient benefiting from a legal protection measure
Bad understanding of French.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient in the first trimester of pregnancy wishing an abortion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antoine KOCH	Contact	+33 3 88 12 83 08		antoine.koch@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Les Hôpitaux Universitaires de Strasbourg		Strasbourg		67098	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided