Macroscopic Deciduosis in Pregnancy is Finally a Common Entity (Deciduose)

July 26, 2019 updated by: Centre Hospitalier René Dubos
The purpose of this study is to determine the prevalence of macroscopic deciduosis found randomly in Cesarean sections and the secondary objective to determine the association with any obstetrical complications or adverse effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ectopic decidua or deciduosis is defined as the extrauterine location of decidual tissue and can occur in the cervix, vagina and various abdominal organs like the ovary omentum, appendix, peritoneum, the pelvic lymph nodes. Other rare sites with deciduosis include the kidneys , the lungs and even the skin . Decidualization is a physiologic process during pregnancy, under the influence of ovarian and placental steroid secretion, with total involution in the four to six week post partum period.

Study Type

Observational

Enrollment (Actual)

31

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All cesaren section

Description

Inclusion Criteria:

  • All cesarean section

Exclusion Criteria:

  • Patients refusing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cases of cesarean section.
Time Frame: During cesarean section.
The purpose of this study is to measure the number of participants who developed macroscopic decidosis in caesareans.
During cesarean section.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier René Dubos

Investigators

  • Principal Investigator: Georges MARKOU, Centre Hospitalier Rene Dubos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD0315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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