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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

1000

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Ankara University

Collaborators

Middle East Technical University

Investigators

  • 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

February 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

February 22, 2015

First Submitted That Met QC Criteria

March 14, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 14, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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