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

November 23, 2016 updated by: Meir Medical Center
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Karman curettage
after a retained product of interception is observed in ultrasound examination, the women in this arm will undergo Karman curretage.
Device: Karman curettage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completing the abortion
Time Frame: 1 month
completing the abortion until the scheduled day for hysteroscopy, thus preventing the need for hysteroscopy
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of days of bleeding
Time Frame: 3 months
asking the patient how many days of bleeding did she have after the procedure
3 months
pregnancy
Time Frame: 3 months
asking the patient if she is currently pregnant
3 months
Pain intensity
Time Frame: 3 months
asking the patient about the intensity of the pain during and after the procedure, as measured with NRS-11 pain scale
3 months
infection
Time Frame: 3 months
asking the patient if she was diagnosed with any infection signs
3 months
number of sick days
Time Frame: 3 months
asking the patients how many sick leave days did she take
3 months
number of days of abstinence from sexual intercourse
Time Frame: 3 months
asking the patient how many days did she abstain from sexual intercourse after the procedure
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Meir Pomeranz, MD, Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Estimate)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 177-16-MMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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