LaborNCT01009411
Labor Progress Indices and the Dynamics of the Individual Contraction During the Active Stage of Labor
An observational study of Labor, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Nulliparous women over 18 years admitted to the labor in active labor
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients in active phase of labor not augmented | |
| Augmented | Augmentation leading to normal progress | |
| Caesarean section | Augmentation leading to Caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Track measurements versus manual measurements
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Collaborators
- Barnev Ltd
- Responsible party
- Principal investigator, Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
- Investigators
- Prof. Ofer Barnea, Phd., Study chair, Barnev LtdProf. Ofer Barnea, Phd., Study director, Barnev Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009411
- Sponsor's protocol ID
- BT-1-IS-001
- Status last verified
- Jun 2014
- First submitted
- 20 Oct 2009
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Study of the Active Stage of Labor
- ClinicalTrials.gov ID
- NCT01009411
- Acronym / sponsor ID
- BT-1-IS-001
- Conditions
- Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Collaborators
- Barnev Ltd
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients in active phase of labor not augmented |
| Augmented | – | –Augmentation leading to normal progress |
| Caesarean section | – | –Augmentation leading to Caesarean section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Nulliparous women over 18 years admitted to the labor in active labor
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Parturients in natural birth without epidural anesthesia
- Low lying placenta
- Known or suspected fetal or maternal infection
- Maternal thrombocytopenia
- Maternal bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Birth Track measurements versus manual measurements
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Ofer Barnea, Phd. study chair
Barnev Ltd
Prof. Ofer Barnea, Phd. study director
Barnev Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth Track measurements versus manual measurements (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2014.