Doppler Flow Measurements in Patients With Misoprostol Tr... | NCT01639976

Studies
Doppler Flow Measurements in Patients With Misoprostol Treatment for Arrested Pregnancy

NCT01639976

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jul 13, 2012Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Missed Abortion

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Sep 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Jul 11, 2012

First Submission Date that Met QC Criteria

Jul 12, 2012

First Posted Date

Jul 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2012

Last Update Posted Date

Jul 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Testing the whether Doppler studies after cytotec treatment can predict success of treatment.

Detailed Description

All women who are treated with Cytotec for a missed abortion at 1st trimester will have a follow up ultrasound exam.

Doppler measurements will be performed but will be hidden from the clinicians. After the conclusion of treatment, data on Doppler would be vevealed in order to see if positive Doppler after Cytotec is predictive of failure of treatment or the need in several doses of cytotec.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with miss abortion who choose treatment with cytotec

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

Women with miss abortion who choose treatment with cytotec

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alon Shrim, MD	Contact	+97246188243		alon.shrim@gmail.com

Overall Officials

Name	Affiliation	Role
Alon Shrim, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera			Israel

Condition Browse Module

MeSH Terms

ID	Term
D000030	Abortion, Missed
D000022	Abortion, Spontaneous

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided