Prevention of Recurrent Preterm Delivery by a Natural Pro... | NCT00329316

Studies
Prevention of Recurrent Preterm Delivery by a Natural Progesterone Agent

NCT00329316

Sponsor

The Baruch Padeh Medical Center, Poriya

Status

Withdrawn

Last Update Posted

Jun 27, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Pregnancy
Premature Birth

Interventions

Crinone Gel 8%

Countries

Not provided

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

Jun 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study withdrawn for financial problems. We didnwt get a grant we needed for purchesing the medication for the study.

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 23, 2006

First Submission Date that Met QC Criteria

May 23, 2006

First Posted Date

May 24, 2006Estimated

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

Jun 26, 2008

Last Update Posted Date

Jun 27, 2008Estimated

Description Module

Brief Summary

To examine the preterm delivery rate of a preterm delivery high risk group of pregnant women, using once daily natural progesterone agent.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Crinone Gel 8%	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnancy 24 weeks' gestation Preterm labor in previous pregnancies

Exclusion Criteria:

No medications for PTL or any kind of progesterone.
Cervical suture
Multiple pregnancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuri Perlitz, MD	The Baruch Padeh Medical Center, Poriya	Study Chair
Mosheh Ben Ami, Prof.	Head of Obs/Gyn ,The Baruch Padeh Medical center, Poriya	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided