Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography
NCT ID: NCT02393144
Last Updated: 2015-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2015-02-28
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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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.
Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System
Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography
Cardiotocography, Bionet FC1400 Fetal Monitor
Assessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors.
Amniotomy
Artificial rupture of membranes to assess meconium staining and induce labor speed.
Analgesics, Opioid, Meperidine
Administration of meperidine for labor analgesia.
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.
Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System
Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography
Cardiotocography, Bionet FC1400 Fetal Monitor
Assessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors.
Amniotomy
Artificial rupture of membranes to assess meconium staining and induce labor speed.
Analgesics, Opioid, Meperidine
Administration of meperidine for labor analgesia.
Labor induction, Oxytocin
Oxytocin infusion for induction of labor.
Cervical ripening, labor induction, Dinoprostone
Administration of dinoprostone pessary for cervical ripening and labor induction.
Interventions
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Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System
Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography
Cardiotocography, Bionet FC1400 Fetal Monitor
Assessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors.
Amniotomy
Artificial rupture of membranes to assess meconium staining and induce labor speed.
Analgesics, Opioid, Meperidine
Administration of meperidine for labor analgesia.
Labor augmentation, Oxytocin
Oxytocin infusion for augmentation of labor.
Labor induction, Oxytocin
Oxytocin infusion for induction of labor.
Cervical ripening, labor induction, Dinoprostone
Administration of dinoprostone pessary for cervical ripening and labor induction.
Eligibility Criteria
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Inclusion Criteria
* Spontaneous labor
* Induced labor
Exclusion Criteria
* 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.)
16 Years
49 Years
FEMALE
Yes
Sponsors
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Middle East Technical University
OTHER
Ankara University
OTHER
Responsible Party
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Erkan Kalafat
Research Assistant
Principal Investigators
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Acar F Koc, Professor
Role: STUDY_DIRECTOR
Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
Locations
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Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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