Placenta, RetainedNCT04720885
Management of Large Retained Products of Conception (> 4 cm): Need for an Standardized Procedure.
An observational study of Placenta, Retained and Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta, Retained, Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage, Placenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage)
- What is being tested?
- kind of surgery
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Dec 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with a placental remnant in medical history.
Who may be able to join
- retained products of conception larger than 4 cm in largest dimension
Who cannot join
- retained products of conception 4 cm or smaller in largest dimension
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Placenta, Retained, Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage, Placenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage), Pregnancy Related, Hysteroscopy / Methods, Retrospective Studies
- Being tested
- kind of surgery
- Medical subject headings
- Placenta, Retained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kind of surgeryProcedure or surgery
hysteroscopy, curettage, other
| Study group | Role | What they receive |
|---|---|---|
| Patients with a placental remnant in medical history | Not described Receives: Procedure: kind of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hysteroscopy
Kind of surgery to remove retained products of conception
Measured: time of surgery
Vacuum Curettage
Kind of surgery to remove retained products of conception
Measured: time of curettage
Polyp forceps
Surgical instrument to remove retained products of conception
Measured: time of surgery
Prostaglandines
Pharmacological agent to remove retained products of conception
Measured: time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start28 Dec 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta, RetainedStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjalina Hamerlynck, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720885
- Sponsor's protocol ID
- BC-07879-ADP
- Status last verified
- May 2023
- First submitted
- 18 Jan 2021
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Large Retained Products of Conception (> 4 cm): Need for an Standardized Procedure.
- ClinicalTrials.gov ID
- NCT04720885
- Acronym / sponsor ID
- BC-07879-ADP
- Conditions
- Placenta, Retained, Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage, Placenta; Retention, Fragments, Complicating Puerperium (Delayed Hemorrhage), Pregnancy Related, Hysteroscopy / Methods, Retrospective Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a placental remnant in medical history | – | Procedure: kind of surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with a placental remnant in medical history.
Key inclusion criteria (1 listed)
- retained products of conception larger than 4 cm in largest dimension
Key exclusion criteria (1 listed)
- retained products of conception 4 cm or smaller in largest dimension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kind of surgeryhysteroscopy, curettage, other | Procedure or surgery | Patients with a placental remnant in medical history |
Primary outcome
Hysteroscopy
Time frame: time of surgery
Kind of surgery to remove retained products of conception
Vacuum Curettage
Time frame: time of curettage
Kind of surgery to remove retained products of conception
Polyp forceps
Time frame: time of surgery
Surgical instrument to remove retained products of conception
Prostaglandines
Time frame: time of surgery
Pharmacological agent to remove retained products of conception
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
Related trials for Placenta, Retained
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Recruiting
Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
Retained Products of Conception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjalina Hamerlynck, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta, Retained and Placenta; Retention, Fragments, Complicating Puerperium, Without Hemorrhage, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hysteroscopy (time frame: time of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.