Labor Progress Indices and the Dynamics of the Individual Contraction During the Active Stage of Labor

NCT01009411 | Completed

• 1 other identifier: BT-1-IS-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objective of the study: to obtain new data on the dynamics of the labor process, cervix dilatation and head station on the labor process and to develop a new progress indices. Background: the best method used today to supervise the labor process is to follow cervix dilatation and head station. Today, the physician or the midwife use manual examination to estimate cervix dilatation and head station. This examination is perform many times in a normal labor process, and even more if there is any delay. The information from these examinations is inaccurate and non-continuous. In case of delay in the labor process, the delay will diagnosed late, because the frequency of the manual examination is about once an hour. With the assistance of the BirthTrack device we can get continuous data on the labor process and get indices to estimate the labor process progress without the use of vaginal (manual) examination. 40 women in an active labor will take part in the study. Method: by connecting sensors to the woman abdomen, to the cervix and to the baby head we follow the cervix dilatation and the fetus head station.

Conditions

Labor

Outcome Measures

Primary Outcomes (1)

• Birth Track measurements versus manual measurements

  1 year

Study Arms (3)

Control

Patients in active phase of labor not augmented

Augmented

Augmentation leading to normal progress

Caesarean section

Augmentation leading to Caesarean section

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Nulliparous women over 18 years admitted to the labor in active labor

You may qualify if:

• Nulliparous women 18 years or older admitted to the labor and delivery unit in active labor (3cm dilatation and contractions).
• Parturients with epidural anesthesia
• Singleton fetus in vertex presentation
• Gestational age 37 or more
• Reassuring fetal heart tracing
• The woman is able to read and understand the consent form

You may not qualify if:

• Parturients in natural birth without epidural anesthesia
• Low lying placenta
• Known or suspected fetal or maternal infection
• Maternal thrombocytopenia
• Maternal bleeding disorder
• Known major fetal malformation
• Suspected fetal growth restriction
• Subjects with significant psychiatric history
• Subjects with indication for immediate delivery
• Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead
• Barnev Ltd: collaborator

Study Sites (1)

Westren Gallilie Hospital

Nahariya, Israel

Location

Study Officials

• Prof. Ofer Barnea, Phd.

  Barnev Ltd

  STUDY CHAIR

• Prof. Ofer Barnea, Phd.

  Barnev Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 20, 2009
• First Posted: November 6, 2009
• Study Start: September 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

IL (1)