Assessment of Labour Progress by Intrapartum Ultrasound
NCT ID: NCT04651309
Last Updated: 2020-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2019-08-27
2020-09-05
Brief Summary
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Detailed Description
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The digital vaginal examination remains to this day the standard method for evaluating the patient's cervical status. However, this method is both highly subjective as well as painful and stressogenic for the patients.
In recent years there has been great progress in the field of translabial/transperineal sonography. There have been several studies which showed that this technique could be as useful as digital examinations in helping clinicians predict the course of labor. Recent studies demonstrate that using transperineal sonography can reduce the perception of pain compared with routine digital vaginal examinations. Even so, there has been little evidence as to whether using perineal ultrasound may also reduce peripartum and puerperal infections and if using sonography and refraining from digital examinations affects the course and duration of labor.
Our objective is to evaluate whether the incidence of chorioamnionitis or fever can be decreased. This goal would hopefully be achieved by assessing the progression of labor using mostly transperineal ultrasound, thus avoiding digital vaginal examination as much as possible.
The study would focus on primigravid women as they are known to be in a higher risk for infection and also other potential risk factors such as GBS carriers and PROM.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Ultrasound group
Labor progress assessed by US, avoiding digital exams as much as possible;
Transperineal Ultrasound
The ultrasound examination will be conducted using the technique described by Hassan et al (2013). Briefly, transperineal ultrasound images are obtained by placing a covered transducer between the labia below the symphysis pubis. Small lateral movements of the probe are then made to align the ultrasound beam in a midsagittal orientation to include the whole cervical length after which the probe is rotated 90 degrees in order to measure the cervical dilatation. The probe is rotated up and down until the echogenic circle of the cervix is seen. Please note that this technique is widely used within the delivery room and that the ultrasound machine that will be used is frequently used within the delivery room.
Control group
Labor progress assessed according to the regular protocol
No interventions assigned to this group
Interventions
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Transperineal Ultrasound
The ultrasound examination will be conducted using the technique described by Hassan et al (2013). Briefly, transperineal ultrasound images are obtained by placing a covered transducer between the labia below the symphysis pubis. Small lateral movements of the probe are then made to align the ultrasound beam in a midsagittal orientation to include the whole cervical length after which the probe is rotated 90 degrees in order to measure the cervical dilatation. The probe is rotated up and down until the echogenic circle of the cervix is seen. Please note that this technique is widely used within the delivery room and that the ultrasound machine that will be used is frequently used within the delivery room.
Eligibility Criteria
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Inclusion Criteria
* Gestational age ≥ 37 weeks (according to 1st trimester sonography)
* Single fetus •Cephalic presentation
Exclusion Criteria
* Women who are taking immunosuppressive therapy
* Women who arrived in active labor and delivered before being assessed by a physician.
* Women with contra-indications for vaginal birth
FEMALE
Yes
Sponsors
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Kaplan Medical Center
OTHER
Responsible Party
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Principal Investigators
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Maya Oberman, MD
Role: PRINCIPAL_INVESTIGATOR
Kaplan Medical Center
Locations
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Maya Oberman
Rehovot, , Israel
Countries
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References
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Gabbe, Steven G, Obstetrics: normal and problem pregnancies , Seventh edition. ..2017
Seaward PG, Hannah ME, Myhr TL, Farine D, Ohlsson A, Wang EE, Haque K, Weston JA, Hewson SA, Ohel G, Hodnett ED. International Multicentre Term Prelabor Rupture of Membranes Study: evaluation of predictors of clinical chorioamnionitis and postpartum fever in patients with prelabor rupture of membranes at term. Am J Obstet Gynecol. 1997 Nov;177(5):1024-9. doi: 10.1016/s0002-9378(97)70007-3.
Benediktsdottir S, Eggebo TM, Salvesen KA. Agreement between transperineal ultrasound measurements and digital examinations of cervical dilatation during labor. BMC Pregnancy Childbirth. 2015 Oct 24;15:273. doi: 10.1186/s12884-015-0704-z.
Yuce T, Kalafat E, Koc A. Transperineal ultrasonography for labor management: accuracy and reliability. Acta Obstet Gynecol Scand. 2015 Jul;94(7):760-765. doi: 10.1111/aogs.12649. Epub 2015 May 5.
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.
Seval MM, Yuce T, Kalafat E, Duman B, Aker SS, Kumbasar H, Koc A. Comparison of effects of digital vaginal examination with transperineal ultrasound during labor on pain and anxiety levels: a randomized controlled trial. Ultrasound Obstet Gynecol. 2016 Dec;48(6):695-700. doi: 10.1002/uog.15994. Epub 2016 Nov 8.
Oberman M, Avrahami I, Lavi Shoseyov N, Kandel A, Ben-Arie A, Sacagiu M, Vaisbuch E, Levy R. Assessment of labor progress by ultrasound vs manual examination: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Feb;5(2):100817. doi: 10.1016/j.ajogmf.2022.100817. Epub 2022 Nov 16.
Hsu S, Selen DJ, James K, Li S, Camargo CA Jr, Kaimal A, Powe CE. Assessment of the Validity of Administrative Data for Gestational Diabetes Ascertainment. Am J Obstet Gynecol MFM. 2023 Feb;5(2):100814. doi: 10.1016/j.ajogmf.2022.100814. Epub 2022 Nov 15.
Other Identifiers
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0118-17-KMC
Identifier Type: -
Identifier Source: org_study_id