Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02393144

Enrollment

1000

Registered

2015-03-19

Start date

2015-02-28

Completion date

2017-03-31

Last updated

2015-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Obstetric Labor

Keywords

Labor analysis, Transperineal ultrasound imaging, Labor curve

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.

Interventions

DEVICETransperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System

Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography

DEVICECardiotocography, Bionet FC1400 Fetal Monitor

Assessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors.

OTHERAmniotomy

Artificial rupture of membranes to assess meconium staining and induce labor speed.

DRUGAnalgesics, Opioid, Meperidine

Administration of meperidine for labor analgesia.

DRUGLabor augmentation, Oxytocin

Oxytocin infusion for augmentation of labor.

DRUGLabor induction, Oxytocin

Oxytocin infusion for induction of labor.

DRUGCervical ripening, labor induction, Dinoprostone

Administration of dinoprostone pessary for cervical ripening and labor induction.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 49 Years

Healthy volunteers

Yes

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.)

Design outcomes

Primary

Measure	Time frame	Description
Duration of active labor	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.
Rate of cervical dilatation advancement as measured by transperineal ultrasonography	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.
Rate of angle of progression advancement as measured by transperineal ultrasonography	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

Measure	Time frame	Description
Effect of amniotomy on duration of active labor	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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactErkan Kalafat, M.D

ekalafat@ankara.edu.tr905334736998

Backup ContactTuncay Yuce, M.D

drtuncayyuce@gmail.com905055943521

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026