Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography

Ankara University

Status: Unknown

Conditions: Obstetric Labor; Pregnancy

Treatments: Other: Amniotomy; Drug: Cervical ripening, labor induction, Dinoprostone; Drug: Labor induction, Oxytocin; Drug: Labor augmentation, Oxytocin; Device: Cardiotocography, Bionet FC1400 Fetal Monitor; Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System; Drug: Analgesics, Opioid, Meperidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02393144

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 16 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

1,000 participants in 2 patient groups

Spontaneous labor arm

Other group

Description:

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.

Treatment:

Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System

Drug: Labor augmentation, Oxytocin

Device: Cardiotocography, Bionet FC1400 Fetal Monitor

Other: Amniotomy

Drug: Analgesics, Opioid, Meperidine

Induced labor arm

Other group

Description:

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.

Treatment:

Drug: Cervical ripening, labor induction, Dinoprostone

Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System

Drug: Labor induction, Oxytocin

Device: Cardiotocography, Bionet FC1400 Fetal Monitor

Other: Amniotomy

Drug: Analgesics, Opioid, Meperidine