NCT03052699

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

September 13, 2016

Last Update Submit

February 10, 2017

Conditions

Complications; Cesarean Section

Keywords

Complications; Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • Risk factors of the maternal morbi-mortality by collection of adverse events during the pregnancy, concomitant pathologies and antecedents

    1 day

Study Arms (1)

vaginal Cesarean Section

patients operated to vaginal Cesarean Section

Procedure: vaginal Cesarean Section

Interventions

vaginal Cesarean SectionPROCEDURE

follow-up to patients operated for vaginal Cesarean Section

vaginal Cesarean Section

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients operated to vaginal Cesarean in Hospital Rene DUBOS

You may qualify if:

  • patients operated to vaginal Cesarean in Hospital Rene DUBOS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • MARKOU Georges, PH

    Rene Dubos Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

February 14, 2017

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 14, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share