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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Labor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Patients in active phase of labor not augmented

No interventions assigned to this group

Augmented

Augmentation leading to normal progress

No interventions assigned to this group

Caesarean section

Augmentation leading to Caesarean section

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes