Management of Large Retained Products of Conception (> 4... | NCT04720885

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

NCT04720885

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

May 11, 2023Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Placenta, Retained
Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage
Placenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage)
Pregnancy Related
Hysteroscopy / Methods
Retrospective Studies
Vacuum Curettage

Interventions

kind of surgery

Countries

Belgium

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

Status Module

Record Verification Date

May 2023

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

Dec 28, 2020Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Aug 31, 2021Actual

First Submitted Date

Jan 18, 2021

First Submission Date that Met QC Criteria

Jan 18, 2021

First Posted Date

Jan 22, 2021Actual

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

May 9, 2023

Last Update Posted Date

May 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

Detailed Description

Not provided

Conditions Module

Conditions

Placenta, Retained
Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage
Placenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage)
Pregnancy Related
Hysteroscopy / Methods
Retrospective Studies
Vacuum Curettage

Keywords

Not provided

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

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with a placental remnant in medical history			Procedure: kind of surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
kind of surgery	Procedure	hysteroscopy, curettage, other	Patients with a placental remnant in medical history

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Patients with a placental remnant in medical history.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tjalina Hamerlynck, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University Hospital		Ghent		9000	Belgium

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010922	Placenta Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases