Sonopartogram. The Next Step in the Delivery Room

NCT02326077 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2020-03-31

No results posted yet for this study

Summary

Objectives:

* Evaluation of the correlation between the sonographic parameter and clinical findings (e.g. digital examination) in any cephalic (not only occipital anterior) position
* Examination of the relationship between various sonographic parameters
* Determination of intraobserver and interobserver variation in obtaining the sonographic measurements
* Analysis of the temporal variation of the different sonographic measurements in normal spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior versus those with persistent occiput posterior
* Establishment of a sonopartogram that should replace in an objective way Friedmann
* Establishment of cut-off values that may help clinicians to choose between vaginal operative delivery or caesarean section
* Another interesting aspect of intrapartum transperineal ultrasound imaging is whether there is a psychological benefit to the patient in being able to follow on the ultrasound screen how fetal head descent and position are being assessed objectively.

Conditions

  • Normal Labor
  • Obstetric Labor Complications

Interventions

OTHER

Ultrasound

Monitoring of the mechanism of labor

OTHER

Acceptability of ultrasound monitoring of labor

Evaluation of the acceptability of intrapartum ultrasound monitoring - the rate of uptake ultrasound protocol during labor

OTHER

Patients' experience regarding intrapartum ultrasound

The day after birth, consenting women are invited to take part in a questionnaire survey. Questionnaires contained no identifying information other than a code number and contains features regarding the patient's impression about the ultrasound monitoring scans during labor. The final questions concerned the willingness of having again another such protocol for labor monitoring in the future.

Sponsors & Collaborators

  • University of Athens

    collaborator OTHER
  • University of Medicine and Pharmacy Craiova

    lead OTHER

Principal Investigators

  • Nicolae Cernea, Professor · University of Medicine and Pharmacy Craiova

  • Dominic G Iliescu, Lecturer · University of Medicine and Pharmacy Craiova

  • Stefania Tudorache, Lecturer · University of Medicine and Pharmacy Craiova

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-10-01
Completion
2023-10-31

Countries

  • Greece
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02326077 on ClinicalTrials.gov