Testing the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion

Abortion, Missed Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02917785
• Other study ID #: 177-16-MMC
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2016
• Last updated: November 23, 2016
• Start date: October 2016

Study information

• Verified date: September 2016
• Source: Meir Medical Center
• Contact: Meir Pomeranz, MD
• Email: pomeranzmiki[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Missed

Intervention

Device:
• Karman curettage

Locations

Country	Name	City	State
Israel	Meir Medical center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completing the abortion	completing the abortion until the scheduled day for hysteroscopy, thus preventing the need for hysteroscopy	1 month	No
Secondary	number of days of bleeding	asking the patient how many days of bleeding did she have after the procedure	3 months	No
Secondary	pregnancy	asking the patient if she is currently pregnant	3 months	No
Secondary	Pain intensity	asking the patient about the intensity of the pain during and after the procedure, as measured with NRS-11 pain scale	3 months	No
Secondary	infection	asking the patient if she was diagnosed with any infection signs	3 months	Yes
Secondary	number of sick days	asking the patients how many sick leave days did she take	3 months	No
Secondary	number of days of abstinence from sexual intercourse	asking the patient how many days did she abstain from sexual intercourse after the procedure	3 months	No