NCT02326077

Brief 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.

Trial Health

37
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
5.8 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

December 20, 2014

Last Update Submit

March 29, 2020

Conditions

Normal LaborObstetric Labor Complications

Keywords

sonopartogramtransperineal ultrasoundintrapartum ultrasoundlabordeliverypartogramultrasound

Outcome Measures

Primary Outcomes (1)

  • Sonopartogram. Longitudinal assessment of the mechanism of labor using ultrasound parameters.

    5 years

Study Arms (1)

Intervention group

Clinical evaluation in active labor: Leopold manoeuvres, vaginal digital examination. Transabdominal and transperineal ultrasound evaluations of the mechanism of labor: fetal head position, progression and rotation. Investigation by questionnaire regarding the psychological impact of labor monitoring assisted by sonoraphy.

Other: UltrasoundOther: Acceptability of ultrasound monitoring of laborOther: Patients' experience regarding intrapartum ultrasound

Interventions

UltrasoundOTHER

Monitoring of the mechanism of labor

Intervention group
Acceptability of ultrasound monitoring of laborOTHER

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

Intervention group
Patients' experience regarding intrapartum ultrasoundOTHER

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.

Intervention group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The pregnant women admitted in active labor at term were considered eligible for the study. They are included in the study consecutively, depending on the availability of the US operators involved.

You may qualify if:

  • active labor
  • singleton pregnancy
  • eutrophic fetus
  • cephalic presentation

You may not qualify if:

  • indication for elective caesarean section
  • non-cephalic presentation
  • prior caesarean delivery
  • fetal hypotrophy or macrosomy
  • multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alexandra University Hospital

Athens, Greece

Location

University Emergency County Hospital

Craiova, Dolj, 200642, Romania

Location

Related Publications (13)

  • Zhang J, Troendle JF, Yancey MK. Reassessing the labor curve in nulliparous women. Am J Obstet Gynecol. 2002 Oct;187(4):824-8. doi: 10.1067/mob.2002.127142.

    PMID: 12388957BACKGROUND

  • Rayburn WF, Siemers KH, Legino LJ, Nabity MR, Anderson JC, Patil KD. Dystocia in late labor: determining fetal position by clinical and ultrasonic techniques. Am J Perinatol. 1989 Jul;6(3):316-9. doi: 10.1055/s-2007-999602.

    PMID: 2659012BACKGROUND

  • Kreiser D, Schiff E, Lipitz S, Kayam Z, Avraham A, Achiron R. Determination of fetal occiput position by ultrasound during the second stage of labor. J Matern Fetal Med. 2001 Aug;10(4):283-6. doi: 10.1080/714904341.

    PMID: 11531156BACKGROUND

  • Sherer DM, Miodovnik M, Bradley KS, Langer O. Intrapartum fetal head position I: comparison between transvaginal digital examination and transabdominal ultrasound assessment during the active stage of labor. Ultrasound Obstet Gynecol. 2002 Mar;19(3):258-63. doi: 10.1046/j.1469-0705.2002.00641.x.

    PMID: 11896947BACKGROUND

  • Sherer DM, Miodovnik M, Bradley KS, Langer O. Intrapartum fetal head position II: comparison between transvaginal digital examination and transabdominal ultrasound assessment during the second stage of labor. Ultrasound Obstet Gynecol. 2002 Mar;19(3):264-8. doi: 10.1046/j.1469-0705.2002.00656.x.

    PMID: 11896948BACKGROUND

  • Akmal S, Tsoi E, Kametas N, Howard R, Nicolaides KH. Intrapartum sonography to determine fetal head position. J Matern Fetal Neonatal Med. 2002 Sep;12(3):172-7. doi: 10.1080/jmf.12.3.172.177.

    PMID: 12530614BACKGROUND

  • Souka AP, Haritos T, Basayiannis K, Noikokyri N, Antsaklis A. Intrapartum ultrasound for the examination of the fetal head position in normal and obstructed labor. J Matern Fetal Neonatal Med. 2003 Jan;13(1):59-63. doi: 10.1080/jmf.13.1.59.63.

    PMID: 12710859BACKGROUND

  • Iliescu DG, Adam G, Tudorache S, Antsaklis P, Cernea N. Quantification of fetal head direction using transperineal ultrasound: an easier approach. Ultrasound Obstet Gynecol. 2012 Nov;40(5):607-8. doi: 10.1002/uog.11117. Epub 2012 Sep 24. No abstract available.

    PMID: 22302748BACKGROUND

  • Hassan WA, Eggebo T, Ferguson M, Gillett A, Studd J, Pasupathy D, Lees CC. The sonopartogram: a novel method for recording progress of labor by ultrasound. Ultrasound Obstet Gynecol. 2014 Feb;43(2):189-94. doi: 10.1002/uog.13212.

    PMID: 24105734BACKGROUND

  • Eggebo TM. Ultrasound is the future diagnostic tool in active labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):361-3. doi: 10.1002/uog.12417. No abstract available.

    PMID: 23641509BACKGROUND

  • FRIEDMAN EA. Primigravid labor; a graphicostatistical analysis. Obstet Gynecol. 1955 Dec;6(6):567-89. doi: 10.1097/00006250-195512000-00001. No abstract available.

    PMID: 13272981BACKGROUND

  • Tutschek B, Braun T, Chantraine F, Henrich W. A study of progress of labour using intrapartum translabial ultrasound, assessing head station, direction, and angle of descent. BJOG. 2011 Jan;118(1):62-9. doi: 10.1111/j.1471-0528.2010.02775.x. Epub 2010 Nov 18.

    PMID: 21083864BACKGROUND

  • Dira LM, Tudorache S, Antsaklis P, Daskalakis G, Themistoklis D, Belciug S, Stoean R, Novac M, Cara ML, Dragusin R, Florea M, Patru C, Zorila L, Nagy R, Ruican D, Iliescu DG. Sonographic Evaluation of the Mechanism of Active Labor (SonoLabor Study): observational study protocol regarding the implementation of the sonopartogram. BMJ Open. 2021 Sep 7;11(9):e047188. doi: 10.1136/bmjopen-2020-047188.

    PMID: 34493509DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Nicolae Cernea, Professor

    University of Medicine and Pharmacy Craiova

    STUDY CHAIR

  • Dominic G Iliescu, Lecturer

    University of Medicine and Pharmacy Craiova

    STUDY DIRECTOR

  • Stefania Tudorache, Lecturer

    University of Medicine and Pharmacy Craiova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2014

First Posted

December 25, 2014

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 31, 2023

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

RO(1)GR(1)