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

This study has been completed.
Sponsor:
Collaborator:
Barnev Ltd
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01009411
First received: October 20, 2009
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition
Labor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Physiological Study of the Active Stage of Labor

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Birth Track measurements versus manual measurements [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Patients in active phase of labor not augmented
Augmented
Augmentation leading to normal progress
Caesarean section
Augmentation leading to Caesarean section

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009411

Locations
Israel
Westren Gallilie Hospital
Nahariya, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Barnev Ltd
Investigators
Study Chair: Prof. Ofer Barnea, Phd. Barnev Ltd
Study Director: Prof. Ofer Barnea, Phd. Barnev Ltd
  More Information

No publications provided

Responsible Party: Prof. Jacob Bornstein, Chairman, Obstetrics and Gynecology, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01009411     History of Changes
Other Study ID Numbers: BT-1-IS-001
Study First Received: October 20, 2009
Last Updated: June 19, 2014
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on August 28, 2014