Last reviewed · How we verify

NCT02326077: SONOLABOR

Sonopartogram. The Next Step in the Delivery Room

Suspended Last updated 31 March 2020
What this trial tests

trial testing Ultrasound in Normal Labor in 4,000 participants. Suspended.

Timeline
1 October 2020
Primary endpoint
1 October 2021
31 October 2023

Quick facts

Lead sponsorUniversity of Medicine and Pharmacy Craiova
StatusSuspended
Study typeOBSERVATIONAL
Enrollment4,000
Start date1 October 2020
Primary completion1 October 2021
Estimated completion31 October 2023
Sites2 locations across Romania, Greece

Drugs / interventions tested

Conditions studied

Sponsor

University of Medicine and Pharmacy Craiova

Who can join

Eligibility, female only, with Normal Labor or Obstetric Labor Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Acceptability of Intrapartum Ultrasound Monitoring - Experience from a Romanian Longitudinal Study.
    Iliescu DG, Tudorache S, Cara ML, Dragusin R, et al · · 2015 · cited 6× · PMID 30538842 · DOI 10.12865/chsj.41.04.10
  2. Sonographic Evaluation of the Mechanism of Active Labor (SonoLabor Study): observational study protocol regarding the implementation of the sonopartogram.
    Dira LM, Tudorache S, Antsaklis P, Daskalakis G, et al · · 2021 · cited 1× · PMID 34493509 · DOI 10.1136/bmjopen-2020-047188

Verify or expand the search:

Other trials of Ultrasound

Trials testing the same drug.

Other recruiting trials for Normal Labor

Currently open trials in the same condition.

Other University of Medicine and Pharmacy Craiova trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02326077.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing