NCT05759507

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

Same day

First QC Date

February 10, 2023

Last Update Submit

March 6, 2023

Conditions

SurgeryPregnancy ComplicationsPregnancy Related

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Impact on pregnancy

    1 year

Study Arms (1)

patients

Women undergo pregnancy from 5 SA to 41 SA with no limitation of age

Procedure: abdominal surgery

Interventions

abdominal surgeryPROCEDURE
patients

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women going through pregnancy with no limitation of age

You may qualify if:

  • Women going through pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternite Regionale et Universitaire de Nancy

Nancy, Meurthe-et-moselle, 54000, France

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical director

Study Record Dates

First Submitted

February 10, 2023

First Posted

March 8, 2023

Study Start

January 1, 2014

Primary Completion

January 1, 2014

Study Completion

December 1, 2021

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

FR(1)