NCT00496899

Brief Summary

The study is an open label feasibility study. The purpose of the study is to evaluate the ease of use of the Cervical ITR in terms of duration of attachment and number of detachments.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 9, 2008

Status Verified

July 1, 2007

Enrollment Period

3 months

First QC Date

July 4, 2007

Last Update Submit

May 8, 2008

Conditions

ObstetricsLabor

Keywords

LaborObstetriccervical dilatation

Study Arms (1)

1

Women in active labor

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Laboring women reffered to maternity center in active labor (3 -7 cm)dilatation and contraction

You may qualify if:

  • 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

You may not qualify if:

  • Women with abnormal placentation (placenta previa)
  • Women with coagulation abnormalities.
  • Abnormal fetal presentation (breech presentation)
  • Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes.
  • Preterm premature rupture of membranes.
  • Need for immediate delivery (cord prolapsed or suspected placental abruption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv soraski medical center

Tel Aviv, 64239, Israel

Location

Study Officials

  • Ariel Many, MD

    Sackler school of medicine, Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 4, 2007

First Posted

July 6, 2007

Study Start

June 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

May 9, 2008

Record last verified: 2007-07

Locations

IL(1)