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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04720885
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 8.1
• Patients Per Site Per Month: 12.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Placenta, Retained; Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage; Placenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage); Pregnancy Related; Hysteroscopy / Methods; Retrospective Studies; Vacuum Curettage	Procedure: kind of surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Management of Large Retained Products of Conception (> 4 cm): Need for an Standardized Procedure.
• Actual Study Start Date: Dec 28, 2020
• Anticipated Primary Completion Date: Aug 31, 2021
• Anticipated Study Completion Date: Aug 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hysteroscopy [time of surgery]

   Kind of surgery to remove retained products of conception

2. Vacuum Curettage [time of curettage]

   Kind of surgery to remove retained products of conception

3. Polyp forceps [time of surgery]

   Surgical instrument to remove retained products of conception

4. Prostaglandines [time of surgery]

   Pharmacological agent to remove retained products of conception

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT04720885
• Other Study ID Numbers: BC-07879-ADP
• First Posted: Jan 22, 2021
• Last Update Posted: Jan 22, 2021
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Placenta, Retained; Hemorrhage

Study Results

No Results Posted as of Jan 22, 2021