NCT01134926

Brief Summary

The aim of the study is to find out whether conservative treatment - expectant management or medical therapy using misoprostol is beneficial in the case of uterine residua, and which treatment is better.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

May 29, 2010

Last Update Submit

June 21, 2015

Conditions

Intra-uterine Residua

Keywords

Retained products of conceptionresiduamisoprostolexpectant management

Outcome Measures

Primary Outcomes (1)

  • abscence of sonographic finding in the uterine cavity

    ofter one week, the patients will undergo an US examination.Failure of management defined as uterine cavity width \> 15mm

    one week since recruitment

Secondary Outcomes (2)

  • Complications

    Within one week since recruitment

  • Woman's satisfaction

    One week since recruitment

Study Arms (2)

intra-uterine residua. expectant management

NO INTERVENTION

The patients in this arm will not get any treatment and be followed up by US examinations

Intra-uterine residua. misoprostol

EXPERIMENTAL

The patients in this arm will be treated with misoprostol at the recruitment day. If there will be sonographic evidence of intra-uterine residua the day after, they'll gat another dose.

Drug: misoprostol

Interventions

misoprostolDRUG

8oo mcg intravaginal, second dose after one day if there is no response

Also known as: cytotec
Intra-uterine residua. misoprostol

Eligibility Criteria

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

You may qualify if:

  • women with sonographic examination reveals suspicion of intra-uterine residua after completion of pregnancy
  • intrauterine cavity, including endometrium, will be at least 15mm

You may not qualify if:

  • the need for emergency surgical treatment (curettage)
  • fever - at least 38 celsius degree
  • women who had medical termination of pregnancy and the examination is after less then 2 weeks since treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek medical center

Afula, Israel

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • yfat kadan, MD

    haemek medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2010

First Posted

June 2, 2010

Study Start

June 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

IL(1)