History of Changes for Study: NCT00840710

Clinical Feasibility of Birth- Track II System (BT)

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			February 9, 2009	None (earliest Version on record)
2			December 27, 2009	Recruitment Status and Study Status

Comparison Format:

Study Identification


Unique Protocol ID:	BT-II-IS-001
Brief Title:	Clinical Feasibility of Birth- Track II System (BT)
Official Title:	Clinical Feasibility of Birth- Track II System
Secondary IDs:

Study Status


Record Verification:	February 2009
Overall Status:	Unknown status [Previously: Not yet recruiting]
Study Start:	February 2010
Primary Completion:
Study Completion:	August 2010 [Anticipated]

First Submitted:	February 8, 2009
First Submitted that Met QC Criteria:	February 9, 2009
First Posted:	February 10, 2009 [Estimate]

Last Update Submitted that Met QC Criteria:	December 27, 2009
Last Update Posted:	December 29, 2009 [Estimate]

Sponsor/Collaborators

Oversight

Study Description


Brief Summary:	The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.
Detailed Description:

Conditions


Conditions:	Obstetrics Labor
Keywords:	women in active labor

Study Design

Groups and Interventions

Eligibility


Study Population:	Women in active labor
Sampling Method:	Non-Probability Sample
Minimum Age:	17 Years
Maximum Age:	50 Years
Sex:	Female
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions). Gestational age 37-42 weeks. (GA) Single fetus Subjects who understood, agreed and signed the informed consent form Exclusion Criteria: Women with abnormal placentation (placenta previa) Abnormal fetal presentation (breech presentation) Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes. Need for immediate delivery (cord prolapsed or suspected placental abruption)

Contacts/Locations


Study Officials:	Jacob Bornstein, PhD Principal Investigator Westren Gallilie Hospital
Locations:	Israel
	Westren Gallilie Hospital Nahariya, Israel Contact:Principal Investigator: Jacob Bornstein, Phd

IPDSharing


Plan to Share IPD:

References