Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography

Pregnancy Clinical Trial

Official title:

Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02393144
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2015
• Last updated: March 14, 2015
• Start date: February 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2015
• Source: Ankara University
• Contact: Erkan Kalafat, M.D
• Phone: 905334736998
• Email: ekalafat[@]ankara.edu.tr
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 49 Years

Eligibility

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.)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obstetric Labor
• Pregnancy

Intervention

Device:
• 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.

Other:
• Amniotomy
Artificial rupture of membranes to assess meconium staining and induce labor speed.

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Ankara University	Middle East Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Effect of amniotomy on duration of active labor	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.	From time of initial admission until the time of birth, up to 36 hours	No