Sonopartogram. The Next Step in the Delivery Room (SONOLABOR)

March 29, 2020 updated by: University of Medicine and Pharmacy Craiova

Intrapartum Ultrasonography - Sonopartogram. Longitudinal Evaluation of the Mechanism of Active Labor Using Ultrasound Parameters

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Objectives:

  • Evaluation of the correlation between the sonographic parameter and clinical findings (e.g. digital examination) in any cephalic (not only occipital anterior)
  • 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
  • Determination of cut-off values that may help clinicians to choose between vaginal operative delivery or caesarean section
  • Investigation 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.

Methods:

Unselected population Personal characteristics: GA, BMI, age, gesta, para Gestational age of more than 37 completed weeks dated by first- and/or mid-trimester scan.

Each patient provide informed consent before the ultrasound measurements. Transperineal ultrasound imaging and digital examinations in laboring patients with a singleton fetus in cephalic/pelvic presentation. Patients examined in their labor rooms.

Admission time:

  • active labor demonstrated by regular uterine contractions and changes in cervical dilatation of more than 2 cm,
  • subgroup: prolonged second stage of labor (full cervical dilatation for >3 h if regional anesthesia was administered or 2 h in the absence of regional anesthesia in nulliparous women, or for >2 h with regional anesthesia or 1 h without anesthesia in parous women).

Empty bladder. Ultrasound machine with a 3.5-5MHz transducer used for the TA and TPU measurements. The probe enclosed in a latex glove covered with ultrasound gel and was then placed between the labia below the pubic symphysis/perineal.

Measured parameters:

Clinical examination (digital vaginal + Leopold) followed immediately after by the acquisition of the sonographic planes necessary to evaluate:occiput position, the long axis of the pubic symphysis, the infrapubic line, the progression angle, the distance of progession, the direction of progression, the midline angle, the head to perineum distance.

Identification and measurement of caput succedaneum (vertical+orizontal) and molding (vertical) when present.

All parameters recorded electronically for later analysis + volumes, when possible.

TPU scans performed at different times during labor,

  • Hourly until complete dilation (1st phase)
  • At 10 minutes after complete dilation (2nd phase) (at least one contraction between the examinations).

Notation of time delivery later used to calculate the interval from scanning to delivery.

In all cases measurements are performed in concert with digital examinations (immediately after).

Intraobserver and interobserver analysis 100 women assessed by TPU examination in the study, have at least one set of two replicated scans obtained at approximately the same time. These women provide sets of scans at various times throughout labor, used to assess intraobserver variability.

In order to assess interobserver variability, a second/independent and well trained observer, blinded to the other's results,

  • obtain duplicate sets of scans at distinct times of labor among randomly selected women (one woman repeated at three time points). The consecutive scans performed with no more than 3 min between the assessments of the two observers
  • or measuring the parameters stored on 3D volumes by the first observer The goal is to generate paired sets of replicated images under nearly identical conditions.

The measurements from the ultrasound scanning are obtained offline, after the acquisition of the described planes, on the images stored on the US machine hard disk.

Thus, the managing obstetrician is blinded to the transperineal ultrasound findings. Head position obtained by ultrasound imaging is communicated in case of clinical misdiagnose because of ethical reasons.

The decision whether expectant management, vaginal extraction or Cesarean section is appropriate is made exclusively on the basis of clinical examination.

Demographic data are collected including length of the second stage of labor, mode of delivery, maternal and neonatal outcome.

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Alexandra University Hospital
  • Romania
    • Dolj
      • Craiova, Dolj, Romania, 200642
        • University Emergency County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sonopartogram. Longitudinal assessment of the mechanism of labor using ultrasound parameters.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy Craiova

Collaborators

University of Athens

Investigators

  • Study Chair: Nicolae Cernea, Professor, University of Medicine and Pharmacy Craiova
  • Study Director: Dominic G Iliescu, Lecturer, University of Medicine and Pharmacy Craiova
  • Principal Investigator: Stefania Tudorache, Lecturer, University of Medicine and Pharmacy Craiova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

December 20, 2014

First Submitted That Met QC Criteria

December 24, 2014

First Posted (Estimate)

December 25, 2014

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 29, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SONOPARTOGRAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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