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

Physiological Study of the Active Stage of Labor

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.

Study Overview

• Status: Completed
• Conditions: Labor

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel
    • Westren Gallilie Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Parturients in natural birth without epidural anesthesia
2. Low lying placenta
3. Known or suspected fetal or maternal infection
4. Maternal thrombocytopenia
5. Maternal bleeding disorder
6. Known major fetal malformation
7. Suspected fetal growth restriction
8. Subjects with significant psychiatric history
9. Subjects with indication for immediate delivery
10. Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Control; Patients in active phase of labor not augmented
Augmented; Augmentation leading to normal progress
Caesarean section; Augmentation leading to Caesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Birth Track measurements versus manual measurements	1 year

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya
• Collaborators: Barnev Ltd
• Investigators: Study Chair: Prof. Ofer Barnea, Phd., Barnev Ltd; Study Director: Prof. Ofer Barnea, Phd., Barnev Ltd

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 20, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 6, 2009

Study Record Updates

• Last Update Posted (Estimate): June 20, 2014
• Last Update Submitted That Met QC Criteria: June 19, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: BT-1-IS-001