Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography

March 14, 2015 updated by: Erkan Kalafat, Ankara University
Primary aim of this study is to analyse contemporary labor patterns by measuring rate of dilatation and head descent via transperineal ultrasonography. Labor curves will be generated using data regarding rate of dilatation, head-descent obtained via transperineal ultrasonography. Factors which are known to effect duration of labor will be taken into account.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intrapartum sonography is rapidly advancing field in the management of obstetrics labor. Traditional approach to labor management consists evaluation of cervical dilatation, head position and head descent via digital examinations. Rate of progress is evaluated using data of available labor curves. Unsatisfactory progression is either treated with labor augmentation or cesarean section depending on the degree and duration of labor retardation. Transperineal ultrasonography is able to assess cervical dilatation, fetal head descent and head position. Data obtained from analysis of labor via transperineal ultrasonography is not available. This research's primary aim is to generate labor curves using data obtained via ultrasonographic measurements.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Term pregnancies
  • Spontaneous labor
  • Induced labor

Exclusion Criteria:

  • Preterm pregnancy
  • Previous cesarean section
  • Fetal presentation anomalies (breech etc.)
  • 5th minute APGAR score lower than 7
  • Instrumental delivery (forceps or vacuum use)
  • Labor management that is not in accordance with "Safe Prevention of the Primary Cesarean Delivery" guideline by American College of Obstetrics and Gynecology.
  • Fetus suffering visible birth trauma (laceration, fracture etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Spontaneous labor arm
Women with term pregnancies whose labor started spontaneously. Spontaneous labor is determined by either spontaneous rupture of membranes at term and/or powerful, regular uterine contractions that cause cervical change. Women will be admitted to labor ward after initial assessment via transperineal ultrasonography. Labor augmentation will be performed for women with inadequate uterine contractions, i.e. contractions measuring less than Montevideo units, irregular weak uterine contractions. Analgesia will be provided via administration of 50 mg intramuscular meperidine at 2 hour intervals as required. Amniotomy will be performed for women with adequate cervical dilatation and fetal head-descent. Transperineal ultrasonography will be performed at irregular intervals to assess cervical dilatation, angle of progression and fetal head position. After birth, birth time, birth weight, APGAR scores, degree of perineal trauma, episiotomy use will be recorded.
Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System
Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography
Device: Cardiotocography, Bionet FC1400 Fetal Monitor
Assessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors.
Other: Amniotomy
Artificial rupture of membranes to assess meconium staining and induce labor speed.
Drug: Analgesics, Opioid, Meperidine
Administration of meperidine for labor analgesia.
Drug: Labor augmentation, Oxytocin
Oxytocin infusion for augmentation of labor.
Other: Induced labor arm
Women with term pregnancies who are induced for birth before the onset of spontaneous labor. Labor will be induced with either oxytocin infusion for women with high Bishop score, or labor will be induced with dinoprostone pessary for women requiring cervical ripening, i.e. poor. Women will be admitted to labor ward after initial assessment via transperineal ultrasonography. Analgesia will be provided via administration of 50 mg intramuscular meperidine at 2 hour intervals as required. Amniotomy will be performed for women with adequate cervical dilatation and fetal head-descent. Transperineal ultrasonography will be performed at irregular intervals to assess cervical dilatation, angle of progression and fetal head position. After birth, birth time, birth weight, APGAR scores, degree of perineal trauma, episiotomy use will be recorded.
Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System
Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography
Device: Cardiotocography, Bionet FC1400 Fetal Monitor
Assessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors.
Other: Amniotomy
Artificial rupture of membranes to assess meconium staining and induce labor speed.
Drug: Analgesics, Opioid, Meperidine
Administration of meperidine for labor analgesia.
Drug: Labor induction, Oxytocin
Oxytocin infusion for induction of labor.
Drug: Cervical ripening, labor induction, Dinoprostone
Administration of dinoprostone pessary for cervical ripening and labor induction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of active labor
Time Frame: From time of initial admission until the time of birth, up to 36 hours
Duration of active labor will be calculated in minutes, in a reverse fashion, beginning from time of birth and going back to first time of measurement.
From time of initial admission until the time of birth, up to 36 hours
Rate of cervical dilatation advancement as measured by transperineal ultrasonography
Time Frame: From time of initial admission until the time of birth, up to 36 hours
Rate of cervical dilatation assessment will be measured in millimetres/hour in a reverse fashion beginning from the time when maximum dilatation is achieved and going back to time of first measurement.
From time of initial admission until the time of birth, up to 36 hours
Rate of angle of progression advancement as measured by transperineal ultrasonography
Time Frame: From time of initial admission until the time of birth, up to 36 hours
Rate of angle of progression advancement will be measured in metric degree in a reverse fashion beginning from the last measurement taken and going back to first measurement taken.
From time of initial admission until the time of birth, up to 36 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of amniotomy on duration of active labor
Time Frame: From time of initial admission until the time of birth, up to 36 hours
Effect of amniotomy on the duration of labor will be assessed in minutes by analysing the different time points in different labor processes when amniotomy has taken place.
From time of initial admission until the time of birth, up to 36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Middle East Technical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Acar F Koc, Professor, Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001 (Marta Eliza Miller Foundation)

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