Back to resultsTesting the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion
Primary Purpose
Abortion, Missed
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Karman curettage
Sponsored by
About this trial
This is an interventional treatment trial for Abortion, Missed
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Meir Medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Karman curettage
Control
Arm Description
after a retained product of interception is observed in ultrasound examination, the women in this arm will undergo Karman curretage.
Outcomes
Primary Outcome Measures
Completing the abortion
completing the abortion until the scheduled day for hysteroscopy, thus preventing the need for hysteroscopy
Secondary Outcome Measures
number of days of bleeding
asking the patient how many days of bleeding did she have after the procedure
pregnancy
asking the patient if she is currently pregnant
Pain intensity
asking the patient about the intensity of the pain during and after the procedure, as measured with NRS-11 pain scale
infection
asking the patient if she was diagnosed with any infection signs
number of sick days
asking the patients how many sick leave days did she take
number of days of abstinence from sexual intercourse
asking the patient how many days did she abstain from sexual intercourse after the procedure
Full Information
NCT ID
NCT02917785
First Posted
September 7, 2016
Last Updated
November 23, 2016
Sponsor
Meir Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02917785
Brief Title
Testing the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Missed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Karman curettage
Arm Type
Experimental
Arm Description
after a retained product of interception is observed in ultrasound examination, the women in this arm will undergo Karman curretage.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Karman curettage
Primary Outcome Measure Information:
Title
Completing the abortion
Description
completing the abortion until the scheduled day for hysteroscopy, thus preventing the need for hysteroscopy
Time Frame
1 month
Secondary Outcome Measure Information:
Title
number of days of bleeding
Description
asking the patient how many days of bleeding did she have after the procedure
Time Frame
3 months
Title
pregnancy
Description
asking the patient if she is currently pregnant
Time Frame
3 months
Title
Pain intensity
Description
asking the patient about the intensity of the pain during and after the procedure, as measured with NRS-11 pain scale
Time Frame
3 months
Title
infection
Description
asking the patient if she was diagnosed with any infection signs
Time Frame
3 months
Title
number of sick days
Description
asking the patients how many sick leave days did she take
Time Frame
3 months
Title
number of days of abstinence from sexual intercourse
Description
asking the patient how many days did she abstain from sexual intercourse after the procedure
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meir Pomeranz, MD
Email
pomeranzmiki@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meir Pomeranz, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meir Pomeranz, MD
Email
pomeranzmiki@clalit.org.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
34467531
Citation
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.
Results Reference
derived
Learn more about this trial
Testing the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion
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