Retained Products of ConceptionNCT04637373
Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss
A study testing Hysteroscopy in people with Retained Products of Conception and Intrauterine Adhesion, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Retained products of conception (RPOC) and intrauterine adhesions (IUA) may occur following suction curettage for early miscarriage and cause secondary infertility, recurrent pregnancy loss and pregnancy complications. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Retained Products of Conception, Intrauterine Adhesion
- What is being tested?
- Hysteroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2019to 31 Dec 2020
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-40 years who were admitted to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment
Who cannot join
- incomplete and complete abortions, gestational age>13 weeks of gestation, suspected molar pregnancy and patients' contraindications for general anesthesia.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shamir Medical Center
Be’er Ya‘aqov, 7300000
Omer Moore, M.D, +972505191242, omer.moore@gmail.com
About this study
Official title: Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss: Does it Reduce Retained Products of Conception and Postoperative Intrauterine Adhesions?
Retained products of conception (RPOC) and intrauterine adhesions (IUA) may occur following suction curettage for early miscarriage and cause secondary infertility, recurrent pregnancy loss and pregnancy complications. The aim of this study is to investigate whether adding hysteroscopy to suction curettage reduces the rates of RPOC and IUA.
Read the detailed description
This is a descriptive, prospective study. Women aged 18-40 years admitted for surgical evacuation in cases of early missed abortion in a single university affiliated medical center are being recruited. All procedures performed under general anesthesia following cervical ripening with vaginal Misoprostol.
Before the evacuation, a diagnostic hysteroscopy was performed to identify the pregnancy's implantation wall. Subsequently, ultrasound guided suction and curettage directed to the implantation wall is done. Finally, the uterine cavity is evaluated by hysteroscopy for RPOC. Participants are scheduled for follow-up diagnostic office hysteroscopy 2 months after termination of pregnancy for assessment of IUA and RPOC. However, due to restrictions on elective surgical procedures brought on by the Covid-19 pandemic, the follow-up hysteroscopy examination was postponed until 5 to 6 months after termination of pregnancy.
- Being tested
- Hysteroscopy
- Keywords
- intrauterine adhesions, Hysteroscopy, Retained Products of Conception
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyDiagnostic test
adding Hysteroscopy before and after suction curettage for early missed abortion to define the wall of implantation and look for retained products of conception
| Study group | Role | What they receive |
|---|---|---|
| the group | Experimental | Women aged 18-40 years who admit to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment, are having Hysteroscopy assisted suction curettage as detailed previously. retained products of conception found at the end of the procedure, and intrauterine adhesions found on follow up are compared to the data in the literature. Receives: Diagnostic Test: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of Retained products of conception following suction curettage.
Measured: at the end of suction curettage procedure
Secondary outcomes (1)
the occurrence of intra uterine adhesions following targeted suction curettage
Measured: on follow-up office hysteroscopy, 5-6 months after the primary procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jul 2019
- Primary completion4 Nov 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Products of ConceptionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective descriptive study is taking place in a single university affiliated medical center.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637373
- Sponsor's protocol ID
- 0178-19-ASF
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes, going to publish, not deciced on which paper yet
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss: Does it Reduce Retained Products of Conception and Postoperative Intrauterine Adhesions?
- ClinicalTrials.gov ID
- NCT04637373
- Acronym / sponsor ID
- 0178-19-ASF
- Keywords
- intrauterine adhesions, Hysteroscopy, Retained Products of Conception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Nov 2020 (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.
Retained products of conception (RPOC) and intrauterine adhesions (IUA) may occur following suction curettage for early miscarriage and cause secondary infertility, recurrent pregnancy loss and pregnancy complications. The aim of this study is to investigate whether adding hysteroscopy to suction curettage reduces the rates of RPOC and IUA.
Detailed description
This is a descriptive, prospective study. Women aged 18-40 years admitted for surgical evacuation in cases of early missed abortion in a single university affiliated medical center are being recruited. All procedures performed under general anesthesia following cervical ripening with vaginal Misoprostol.
Before the evacuation, a diagnostic hysteroscopy was performed to identify the pregnancy's implantation wall. Subsequently, ultrasound guided suction and curettage directed to the implantation wall is done. Finally, the uterine cavity is evaluated by hysteroscopy for RPOC. Participants are scheduled for follow-up diagnostic office hysteroscopy 2 months after termination of pregnancy for assessment of IUA and RPOC. However, due to restrictions on elective surgical procedures brought on by the Covid-19 pandemic, the follow-up hysteroscopy examination was postponed until 5 to 6 months after termination of pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This prospective descriptive study is taking place in a single university affiliated medical center.
| Arm | Type | Receives |
|---|---|---|
| the group | Experimental | Diagnostic Test: HysteroscopyWomen aged 18-40 years who admit to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment, are having Hysteroscopy assisted suction curettage as detailed previously. retained products of conception found at the end of the procedure, and intrauterine adhesions found on follow up are compared to the data in the literature. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 18-40 years who were admitted to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment
Key exclusion criteria (1 listed)
- incomplete and complete abortions, gestational age>13 weeks of gestation, suspected molar pregnancy and patients' contraindications for general anesthesia.
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 |
|---|---|---|
| Hysteroscopyadding Hysteroscopy before and after suction curettage for early missed abortion to define the wall of implantation and look for retained products of conception | Diagnostic test | the group |
Primary outcome
the occurrence of Retained products of conception following suction curettage.
Time frame: at the end of suction curettage procedure
1 secondary outcome
the occurrence of intra uterine adhesions following targeted suction curettage
Time frame: on follow-up office hysteroscopy, 5-6 months after the primary procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: Undecided. Yes, going to publish, not deciced on which paper yet
Related trials for Retained Products of Conception
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Uterine Polyps, Uterine Fibroids
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Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
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Intracervical Vasopressin
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Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
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Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
Retained Product of Conception After First Trimester Medical Abortion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy in people with Retained Products of Conception and Intrauterine Adhesion, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omer Moore, M.D (+972505191242, omer.moore@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the occurrence of Retained products of conception following suction curettage. (time frame: at the end of suction curettage procedure). 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 19 Nov 2020.