NCT04720885

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 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

December 28, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

January 18, 2021

Last Update Submit

May 9, 2023

Conditions

Placenta, RetainedPlacenta; Retention, Fragments, Complicating Puerperium, Without HemorrhagePlacenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage)Pregnancy RelatedHysteroscopy / MethodsRetrospective StudiesVacuum Curettage

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Patients with a placental remnant in medical history

Procedure: kind of surgery

Interventions

kind of surgeryPROCEDURE

hysteroscopy, curettage, other

Patients with a placental remnant in medical history

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with a placental remnant in medical history.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Placenta, Retained

Condition Hierarchy (Ancestors)

Placenta DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Tjalina Hamerlynck, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 22, 2021

Study Start

December 28, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

BE(1)