Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 22, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 19, 2015
March 1, 2015
1.9 years
February 22, 2015
March 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Duration of active labor
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
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
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 Outcomes (1)
Effect of amniotomy on duration of active labor
From time of initial admission until the time of birth, up to 36 hours
Study Arms (2)
Spontaneous labor arm
OTHERWomen 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.
Induced labor arm
OTHERWomen 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.
Interventions
Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography
Assessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors.
Artificial rupture of membranes to assess meconium staining and induce labor speed.
Administration of meperidine for labor analgesia.
Administration of dinoprostone pessary for cervical ripening and labor induction.
Eligibility Criteria
You may qualify if:
- Term pregnancies
- Spontaneous labor
- Induced labor
You may not qualify if:
- Preterm pregnancy
- Previous cesarean section
- Fetal presentation anomalies (breech etc.)
- th 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ankara Universitylead
- Middle East Technical Universitycollaborator
Study Sites (1)
Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Ankara, 06100, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Acar F Koc, Professor
Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
February 22, 2015
First Posted
March 19, 2015
Study Start
February 1, 2015
Primary Completion
January 1, 2017
Study Completion
March 1, 2017
Last Updated
March 19, 2015
Record last verified: 2015-03