Sonopartogram. The Next Step in the Delivery Room

Obstetric Labor Complications Clinical Trial

— SONOLABOR  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02326077
• Other study ID #: SONOPARTOGRAM
• Status: Suspended
• Start date: October 1, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2020
• Source: University of Medicine and Pharmacy Craiova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 4000
• Est. completion date: October 31, 2023
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Normal Labor
• Obstetric Labor Complications

Intervention

Other:
• Ultrasound
Monitoring of the mechanism of labor
• Acceptability of ultrasound monitoring of labor
Evaluation of the acceptability of intrapartum ultrasound monitoring - the rate of uptake ultrasound protocol during labor
• 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.

Locations

Country	Name	City	State
Greece	Alexandra University Hospital	Athens
Romania	University Emergency County Hospital	Craiova	Dolj

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy Craiova	University of Athens

Countries where clinical trial is conducted

Greece,  Romania, 

References & Publications (12)

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. — View Citation

Eggebø TM. Ultrasound is the future diagnostic tool in active labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):361-3. — View Citation

FRIEDMAN EA. Primigravid labor; a graphicostatistical analysis. Obstet Gynecol. 1955 Dec;6(6):567-89. — View Citation

Hassan WA, Eggebø 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Zhang J, Troendle JF, Yancey MK. Reassessing the labor curve in nulliparous women. Am J Obstet Gynecol. 2002 Oct;187(4):824-8. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sonopartogram. Longitudinal assessment of the mechanism of labor using ultrasound parameters.		5 years