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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01009411
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : June 20, 2014
Barnev Ltd
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya

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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Physiological Study of the Active Stage of Labor
Study Start Date : September 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Patients in active phase of labor not augmented
Augmentation leading to normal progress
Caesarean section
Augmentation leading to Caesarean section

Primary Outcome Measures :
  1. Birth Track measurements versus manual measurements [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01009411

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Westren Gallilie Hospital
Nahariya, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Barnev Ltd
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Study Chair: Prof. Ofer Barnea, Phd. Barnev Ltd
Study Director: Prof. Ofer Barnea, Phd. Barnev Ltd
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Responsible Party: Prof. Jacob Bornstein, Chairman, Obstetrics and Gynecology, Western Galilee Hospital-Nahariya Identifier: NCT01009411    
Other Study ID Numbers: BT-1-IS-001
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014