Evaluation of Practices at the University Hospital of Nan... | NCT05759507

Studies
Evaluation of Practices at the University Hospital of Nancy in the Context of Surgery During Pregnancy

NCT05759507

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Mar 8, 2023Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Surgery
Pregnancy Complications
Pregnancy Related

Interventions

abdominal surgery

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 2023

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

Jan 2014Actual

Primary Completion Date

Jan 2014Actual

Completion Date

Dec 2021Actual

First Submitted Date

Feb 10, 2023

First Submission Date that Met QC Criteria

Mar 6, 2023

First Posted Date

Mar 8, 2023Actual

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 6, 2023

Last Update Posted Date

Mar 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

TOURNIER Mathilde, Clinical director, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

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

About 2% of pregnant women are going through from surgery during pregnancy. These are mainly represented by emergencies like abdominal conditions such as appendicitis.

Pregnancy raises the issue of possible diagnostic confusion associated with operational difficulties related to a gravid uterus, i.e. increased in volume, and possible induced obstetric complications like premature delivery or miscarriage. late.

The management of these patients is therefore complex and the literature is poor on the subject.

Detailed Description

In the CHRU of Nancy because of the lack of guidelines, there is no guidelines on the management around urgent surgery during pregnancy.

The aim is to describe how patients on the 7 last years where taking care of and to examine if there where mistakes and delay due to pregnancy.'

The aim is also to describe the consequences of the surgery and analyse the end of the pregancy

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients		Women undergo pregnancy from 5 SA to 41 SA with no limitation of age	Procedure: abdominal surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
abdominal surgery	Procedure		patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with no mistakes from the diagnosis to the surgery.	days of delay in the diagnosis ? error ? Diagnostic of certitude is established during surgery	1 year

Secondary Outcomes

Measure	Description	Time Frame
Impact on pregnancy	The impact on pregnancy is defined as the issues after surgery such as miscarries, premature labor, neonatal asphyxie etc..	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women going through pregnancy

Exclusion Criteria:

Accepts Healthy Volunteers

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

Women going through pregnancy with no limitation of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternite Regionale et Universitaire de Nancy		Nancy	Meurthe-et-moselle	54000	France

Condition Browse Module

MeSH Terms

ID	Term
D011248	Pregnancy Complications

Ancestor Terms

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided