Labor Progress Indices and the Dynamics of the Individual Contraction During 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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Key information

Conditions

Labor

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Westren Gallilie Hospital

Nahariya, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Birth Track measurements versus manual measurements

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Collaborators

Barnev Ltd

Registry information

Official study title

Physiological Study of the Active Stage of Labor

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Nov 6, 2009
Registry last updated: Jun 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed