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

October 20, 2009
June 19, 2014
September 2010
December 2012   (final data collection date for primary outcome measure)
Birth Track measurements versus manual measurements [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01009411 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

Labor
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  • Control
    Patients in active phase of labor not augmented
  • Augmented
    Augmentation leading to normal progress
  • Caesarean section
    Augmentation leading to Caesarean section
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01009411
BT-1-IS-001
No
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
Western Galilee Hospital-Nahariya
Barnev Ltd
Study Chair: Prof. Ofer Barnea, Phd. Barnev Ltd
Study Director: Prof. Ofer Barnea, Phd. Barnev Ltd
Western Galilee Hospital-Nahariya
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP