Assessment of Labour Progress by Intrapartum Ultrasound

NCT04651309 | Completed DMC

• 1 other identifier: 0118-17-KMC
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of labor progress via digital exams is considered the standard of care in most delivery rooms. However, this method can be stressful, painful and imprecise and multiple exams increase the risk for chorioamnionitis. Trans-perineal ultrasound (TPUS) was found to be an objective noninvasive way to monitor labor progress. The study aim is to investigate whether, in nulliparous women, the use of TPUS during labor can reduce the number of vaginal exams and the incidence of chorioamnionitis.

Conditions

Pregnancy Related; Fever; Chorioamnionitis; Labor Complication

Outcome Measures

Primary Outcomes (2)

• Fever and infection rates in each of the study arms

  Intrapartum and post partum fever rates will be evaluated in both the study and the control groups.

  From admission to hospital for labor until 2 week post-partum

• Number of digital exams in each of the study arms

  The number of digital exams will be counted in each of the study arms

  From admission to hospital until delivery

Study Arms (2)

Ultrasound group

OTHER

Labor progress assessed by US, avoiding digital exams as much as possible;

Other: Transperineal Ultrasound

Control group

NO INTERVENTION

Labor progress assessed according to the regular protocol

Interventions

Transperineal Ultrasound OTHER

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.

Ultrasound group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primigravida
• Gestational age ≥ 37 weeks (according to 1st trimester sonography)
• Single fetus •Cephalic presentation

You may not qualify if:

• o Other known active infection (such as URTI, UTI)
• 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

Sponsors & Collaborators

• Kaplan Medical Center: lead

Study Sites (1)

Maya Oberman

Rehovot, 123456, Israel

Location

Related Publications (8)

• Gabbe, Steven G, Obstetrics: normal and problem pregnancies , Seventh edition. ..2017

  BACKGROUND

• 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.

  PMID: 9396886 BACKGROUND

• 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.

  PMID: 26496894 BACKGROUND

• 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.

  PMID: 25846302 BACKGROUND

• 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: 24105734 BACKGROUND

• 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.

  PMID: 27300158 BACKGROUND

• 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.

  PMID: 36400420 DERIVED

• 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.

  PMID: 36396038 DERIVED

MeSH Terms

Conditions

Fever; Chorioamnionitis; Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Maya Oberman, MD

  Kaplan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: December 3, 2020
• Study Start: August 27, 2019
• Primary Completion: September 5, 2020
• Study Completion: September 5, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

IL (1)