Management of Large Retained Products of Conception (> 4 cm): Need for an Standardized Procedure.

May 9, 2023 updated by: University Hospital, Ghent
Collection of relevant data form patients who were treated in the Ghent University Hospital in the context of a placental remnant lager than 4 cm, performing statistical analyzes on the collected data, reviewing the literature on the subject and formulation of a recommendation for treatment of these large placental remnants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with a placental remnant in medical history.

Description

Inclusion Criteria:

  • retained products of conception larger than 4 cm in largest dimension

Exclusion Criteria:

  • retained products of conception 4 cm or smaller in largest dimension

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a placental remnant in medical history
Procedure: kind of surgery
hysteroscopy, curettage, other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hysteroscopy
Time Frame: time of surgery
Kind of surgery to remove retained products of conception
time of surgery
Vacuum Curettage
Time Frame: time of curettage
Kind of surgery to remove retained products of conception
time of curettage
Polyp forceps
Time Frame: time of surgery
Surgical instrument to remove retained products of conception
time of surgery
Prostaglandines
Time Frame: time of surgery
Pharmacological agent to remove retained products of conception
time of surgery

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Tjalina Hamerlynck, MD, University Hospital, Ghent

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)

December 28, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-07879-ADP

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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