Effect of Vaginal PH on Treatment Effectiveness With Miso... | NCT01270334

Studies
Effect of Vaginal PH on Treatment Effectiveness With Misoprostol for First Trimester Missed Abortions

NCT01270334

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Jan 5, 2011Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

MISED ABORTION- Vaginal PH

Interventions

PH meassurment

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

Jan 2011

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

Feb 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 4, 2011

First Submission Date that Met QC Criteria

Jan 4, 2011

First Posted Date

Jan 5, 2011Estimated

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

Jan 4, 2011

Last Update Posted Date

Jan 5, 2011Estimated

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

vaginal PH has an effect on the effectiveness of treatment with misoprostol given vaginally for missed abortions in the first trimester

Detailed Description

Not provided

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ph above cutoff			Other: PH meassurment
PH under cutoff			Other: PH meassurment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PH meassurment	Other	meassuring ph USING PROBE	PH under cutoff ph above cutoff

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
treatment failure- need for D&C		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
side effects, need foe analgetics, time for compliting abortion		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion

missed abortion under 8 weeks by sac diameter over 18 years old informed concent given

Exclusion Criteria:

missed abortion over 8 weeks hypersensitivity for PG vaginal bleeding suspected EUP IUD heart disease, HTN, cerebral vascular disease, epilepsy intrauterine infection clooting disorder under 18

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

women dignosed with missed abortion in the first trimester

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shira baram, dr	Contact	972-4-6494035		shira_ba@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haemel Medical Center		Afula			Israel