Clinical trial NCT02393144: Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography
Official title: Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Obstetric Labor
Keywords: Labor analysis
Transperineal ultrasound imaging
Labor curve
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Middle East Technical University
First posted: 2015-03-19
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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.

Eligibility 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.)

Primary outcomes:
measure: Duration of active labor
timeFrame: From time of initial admission until the time of birth, up to 36 hours
measure: Rate of cervical dilatation advancement as measured by transperineal ultrasonography
timeFrame: From time of initial admission until the time of birth, up to 36 hours
measure: Rate of angle of progression advancement as measured by transperineal ultrasonography
timeFrame: From time of initial admission until the time of birth, up to 36 hours
Secondary outcomes:
measure: Effect of amniotomy on duration of active labor
timeFrame: From time of initial admission until the time of birth, up to 36 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Study officials:
affiliation: Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
name: Acar F Koc, Professor
role: STUDY_DIRECTOR
References: