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

Labor Clinical Trial

Official title:

Physiological Study of the Active Stage of Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009411
• Other study ID #: BT-1-IS-001
• Status: Completed
• Phase: N/A
• First received: October 20, 2009
• Last updated: June 19, 2014
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Labor

Locations

Country	Name	City	State
Israel	Westren Gallilie Hospital	Nahariya

Sponsors (2)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya	Barnev Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth Track measurements versus manual measurements		1 year	No