Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography

Sponsor
Ankara University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02393144
Collaborator
Middle East Technical University (Other)
1,000
1
2
24.9
40.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System
  • Device: Cardiotocography, Bionet FC1400 Fetal Monitor
  • Other: Amniotomy
  • Drug: Analgesics, Opioid, Meperidine
  • Drug: Labor augmentation, Oxytocin
  • Drug: Labor induction, Oxytocin
  • Drug: Cervical ripening, labor induction, Dinoprostone
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography
Study Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2017
Anticipated Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Spontaneous labor arm

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.

Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System
Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography

Device: 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.

Drug: Labor augmentation, Oxytocin
Oxytocin infusion for augmentation of labor.

Other: Induced labor arm

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.

Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System
Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography

Device: 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.

Drug: Labor induction, Oxytocin
Oxytocin infusion for induction of labor.

Drug: Cervical ripening, labor induction, Dinoprostone
Administration of dinoprostone pessary for cervical ripening and labor induction.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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 Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts 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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology Ankara Turkey 06100

Sponsors and Collaborators

  • Ankara University
  • Middle East Technical University

Investigators

  • Study Director: Acar F Koc, Professor, Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erkan Kalafat, Research Assistant, Ankara University
ClinicalTrials.gov Identifier:
NCT02393144
Other Study ID Numbers:
  • 001
First Posted:
Mar 19, 2015
Last Update Posted:
Mar 19, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Erkan Kalafat, Research Assistant, Ankara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2015