Abortion, MissedNCT02917785
Testing the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion
A study testing Karman curettage in people with Abortion, Missed, run by Meir Medical Center at 1 site in Israel.
Trial summary
the purpose of this study is to examine the success rates of Karman curettage in completing the abortion after failed recurred treatment with Misoprostol for women with missed abortion. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Missed
- What is being tested?
- Karman curettage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2016to Aug 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women diagnosed with missed abortion treated in Meir Medical Center.
- The abortion occured during the first trimester of pregnancy.
- Patients who chose drug therapy (Misoprostol), after retained products of conception were evident on ultrasound.
Who cannot join
- patients with mullarian abnormality (i.e. septal uterus, myoma etc.)
- patients with significant bleeding
- Endometrial wall (residua) greater than 20 mm.
- known or suspected infection
- known clotting defect
- women after cesarean section
- closed cervix
Trial locations and contacts
1 site in 1 country.
Meir Pomeranz, MD contact
Israel1 site, 1 recruiting
- Recruiting
Meir Medical center
Kfar Saba
Meir Pomeranz, MD, pomeranzmiki@clalit.org.il
About this study
the purpose of this study is to examine the success rates of Karman curettage in completing the abortion after failed recurred treatment with Misoprostol for women with missed abortion.
- Conditions
- Abortion, Missed
- Being tested
- Karman curettage
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karman curettageDevice
| Study group | Role | What they receive |
|---|---|---|
| Karman curettage | Experimental | after a retained product of interception is observed in ultrasound examination, the women in this arm will undergo Karman curretage. Receives: Device: Karman curettage |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completing the abortion
completing the abortion until the scheduled day for hysteroscopy, thus preventing the need for hysteroscopy
Measured: 1 month
Secondary outcomes (6)
number of days of bleeding
asking the patient how many days of bleeding did she have after the procedure
Measured: 3 months
pregnancy
asking the patient if she is currently pregnant
Measured: 3 months
Pain intensity
asking the patient about the intensity of the pain during and after the procedure, as measured with NRS-11 pain scale
Measured: 3 months
infection
asking the patient if she was diagnosed with any infection signs
Measured: 3 months
number of sick days
asking the patients how many sick leave days did she take
Measured: 3 months
number of days of abstinence from sexual intercourse
asking the patient how many days did she abstain from sexual intercourse after the procedure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion, MissedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meir Pomeranz, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917785
- Sponsor's protocol ID
- 177-16-MMC
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
Publications
Pomeranz M, Goren Gepstein N, Ovadia M, Klein Z, Daykan Y, Schonman R, Arbib N. A novel method for office aspiration curettage in cases of retained products of conception: A randomized controlled trial. Acta Obstet Gynecol Scand. 2021 Nov;100(11):2076-2081. doi: 10.1111/aogs.14245. Epub 2021 Aug 31.
PubMed 34467531
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion
- ClinicalTrials.gov ID
- NCT02917785
- Acronym / sponsor ID
- 177-16-MMC
- Conditions
- Abortion, Missed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Aug 2017 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- 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.
the purpose of this study is to examine the success rates of Karman curettage in completing the abortion after failed recurred treatment with Misoprostol for women with missed abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Karman curettage | Experimental | Device: Karman curettageafter a retained product of interception is observed in ultrasound examination, the women in this arm will undergo Karman curretage. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy women diagnosed with missed abortion treated in Meir Medical Center.
- The abortion occured during the first trimester of pregnancy.
- Patients who chose drug therapy (Misoprostol), after retained products of conception were evident on ultrasound.
Key exclusion criteria (7 listed)
- patients with mullarian abnormality (i.e. septal uterus, myoma etc.)
- patients with significant bleeding
- Endometrial wall (residua) greater than 20 mm.
- known or suspected infection
- known clotting defect
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 |
|---|---|---|
| Karman curettage | Device | Karman curettage |
Primary outcome
Completing the abortion
Time frame: 1 month
completing the abortion until the scheduled day for hysteroscopy, thus preventing the need for hysteroscopy
6 secondary outcomes
number of days of bleeding
Time frame: 3 months
pregnancy
Time frame: 3 months
Pain intensity
Time frame: 3 months
infection
Time frame: 3 months
number of sick days
Time frame: 3 months
number of days of abstinence from sexual intercourse
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Derived from this study: PubMed 34467531Pomeranz M, Goren Gepstein N, Ovadia M, Klein Z, Daykan Y, Schonman R, Arbib N. A novel method for office aspiration curettage in cases of retained products of conception: A randomized controlled trial. Acta Obstet Gynecol Scand. 2021 Nov;100(11):2076-2081. doi: 10.1111/aogs.14245. Epub 2021 Aug 31.
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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.
Meir Pomeranz, MD contact
Meir Pomeranz, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Karman curettage in people with Abortion, Missed, run by Meir 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 3 inclusion and 7 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 25 Nov 2016. 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 Meir Pomeranz, MD (pomeranzmiki@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completing the abortion (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917785, which also lists 1 linked publication.
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 25 Nov 2016.