Medium and Long-term Complications of the Patients Having... | NCT03052699

Studies
Medium and Long-term Complications of the Patients Having Had a Vaginal Caesarian in Hospital René Dubos

NCT03052699

Sponsor

Hôpital NOVO

Status

Completed

Last Update Posted

Jun 9, 2026Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Complications; Cesarean Section

Interventions

vaginal Cesarean Section

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

Jun 2026

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

Sep 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Sep 13, 2016

First Submission Date that Met QC Criteria

Feb 10, 2017

First Posted Date

Feb 14, 2017Actual

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

Jun 8, 2026

Last Update Posted Date

Jun 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 database has for objective to include the medical data of patients which underwent a vaginal Cesarean Section in our establishment. This collection will allow to determine the risk factors of the maternal morbi-mortality and to estimate the long-term results

Detailed Description

It is about an operating technique little known which is used as an alternative of the abdominal Cesarean Section for very premature pregnancies and the main indication is the maternal rescue.

It has several advantages: simplicity of the technique, the dissection of tissues is limited, low risk of bleeding and no abdominal scar.

The purpose is to determine the risk factors of the maternal morbi-mortality and to estimate the long-term results

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

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vaginal Cesarean Section		patients operated to vaginal Cesarean Section	Procedure: vaginal Cesarean Section

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vaginal Cesarean Section	Procedure	follow-up to patients operated for vaginal Cesarean Section	vaginal Cesarean Section

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk factors of the maternal morbi-mortality by collection of adverse events during the pregnancy, concomitant pathologies and antecedents		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients operated to vaginal Cesarean in Hospital Rene DUBOS

Exclusion Criteria:

patients followed in a maternity which do not participate to the study

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

patients operated to vaginal Cesarean in Hospital Rene DUBOS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MARKOU Georges, PH	Rene Dubos Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital NOVO		Cergy-Pontoise		95300	France

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