RecruitingACTRN12610000990022

Translabial Tridimensional Ultrasound Imaging of Uterine Cervical Dilatation in First Stage of Labor

Intrapartum Translabial Tridimensional Ultrasound Imaging of Uterine Cervical Dilatation in First Stage of Labor - A double Blind Study


Sponsor

Ariel L ZImerman

Enrollment

100 participants

Start Date

Feb 1, 2010

Study Type

Observational

Conditions

Summary

Sudy objective- To assess the use of non invasive intrapartum translabial 3D-US in the diagnosis of latent to active phase transition defined as an increase in cervical dilatation from 3cm to 5cm, and to compare it to digital vaginal examination. Study methods- An observational prospective double blind clinical study. Hourly consecutive translabial 3D-US volumes are obtained in singleton term patients admitted to delivery room. Sonographers are blind to patient’s digital vaginal examination partogram. Patients and delivery room personnel are blind to sonographic results. Obtained volumes will be processed offline. Ultrasound maximal cervical diameter and vaginal digital examination will be compared.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether an ultrasound scan from outside the body (translabial 3D ultrasound) can reliably measure how far the cervix has opened during labor — without needing an internal vaginal examination. Pregnant women admitted to the delivery room will have hourly ultrasound scans, and the results will be compared with standard internal examinations performed by the midwife or doctor. You may be eligible if: - You are a pregnant woman at 37 weeks or more (full term) - You are admitted to the delivery room in active labor - You have a single baby in the head-down position - You agree to participate and sign informed consent You may NOT be eligible if: - You are less than 37 weeks pregnant (preterm) - You are carrying twins or more - Your baby is not in the head-down position - You develop complications such as abnormal fetal heart rate, bleeding, pre-eclampsia, or need for emergency intervention Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intrapartum translabial 3D ultrasonographic imaging of uterine cervix using a Voluson 750 ultrasound system, GE Healthcare, Kretztechnik, Zipf, Austria, with a RAB2-5-RS 2- to 5-MHz convex 4-dimension

Intrapartum translabial 3D ultrasonographic imaging of uterine cervix using a Voluson 750 ultrasound system, GE Healthcare, Kretztechnik, Zipf, Austria, with a RAB2-5-RS 2- to 5-MHz convex 4-dimensional probe. A wrapped ultrasound transducer is placed over patient's perineum, A volume acquisition (lasting around 30seconds) is repeated hourly until cervical dilatation of 5cm is reached


Locations(1)

Tzeriffin, Israel

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ACTRN12610000990022