NCT02917785

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

November 25, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 7, 2016

Last Update Submit

November 23, 2016

Conditions

Abortion, Missed

Outcome Measures

Primary Outcomes (1)

  • Completing the abortion

    completing the abortion until the scheduled day for hysteroscopy, thus preventing the need for hysteroscopy

    1 month

Secondary Outcomes (6)

  • number of days of bleeding

    3 months

  • pregnancy

    3 months

  • Pain intensity

    3 months

  • infection

    3 months

  • number of sick days

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Karman curettage

EXPERIMENTAL

after a retained product of interception is observed in ultrasound examination, the women in this arm will undergo Karman curretage.

Device: Karman curettage

Control

NO INTERVENTION

Interventions

Karman curettageDEVICE
Karman curettage

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical center

Kfar Saba, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34467531DERIVED

MeSH Terms

Conditions

Abortion, Missed

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Meir Pomeranz, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meir Pomeranz, MD

CONTACT

pomeranzmiki@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 28, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2017

Last Updated

November 25, 2016

Record last verified: 2016-09

Locations

IL(1)