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Trial record 19 of 80602 for:    measured

Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography

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ClinicalTrials.gov Identifier: NCT02393144
Recruitment Status : Unknown
Verified March 2015 by Erkan Kalafat, Ankara University.
Recruitment status was:  Recruiting
First Posted : March 19, 2015
Last Update Posted : March 19, 2015
Sponsor:
Collaborator:
Middle East Technical University
Information provided by (Responsible Party):
Erkan Kalafat, Ankara University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Obstetric Labor Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System Device: Cardiotocography, Bionet FC1400 Fetal Monitor Other: Amniotomy Drug: Analgesics, Opioid, Meperidine Drug: Labor augmentation, Oxytocin Drug: Labor induction, Oxytocin Drug: Cervical ripening, labor induction, Dinoprostone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography
Study Start Date : February 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393144


Contacts
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Contact: Erkan Kalafat, M.D 905334736998 ekalafat@ankara.edu.tr
Contact: Tuncay Yuce, M.D 905055943521 drtuncayyuce@gmail.com

Locations
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Turkey
Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology Recruiting
Ankara, Turkey, 06100
Contact: Erkan Kalafat       ekalafat@ankara.edu.tr   
Sponsors and Collaborators
Ankara University
Middle East Technical University
Investigators
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Study Director: Acar F Koc, Professor Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine

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Responsible Party: Erkan Kalafat, Research Assistant, Ankara University
ClinicalTrials.gov Identifier: NCT02393144     History of Changes
Other Study ID Numbers: 001
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Keywords provided by Erkan Kalafat, Ankara University:
Labor analysis
Transperineal ultrasound imaging
Labor curve
Additional relevant MeSH terms:
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Meperidine
Analgesics, Opioid
Oxytocin
Dinoprostone
Analgesics
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Central Nervous System Depressants
Adjuvants, Anesthesia