Assessment of Labour Progress by Intrapartum Ultrasound

Pregnancy Related Clinical Trial

Official title:

Assessment of Labour Progress by Intrapartum Ultrasound: Can it Reduce the Incidence of Chorioamnionitis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651309
• Other study ID #: 0118-17-KMC
• Status: Completed
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: September 5, 2020

Study information

• Verified date: December 2020
• Source: Kaplan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The prevalence of chorioamnionitis in term deliveries is 1-5% and in preterm deliveries the numbers can be as high as 25%. Most infections are a result of an ascending infection of the normal vaginal flora. Among risk factors are nulliparity, rupture of membranes, an extended duration of labor, multiple vaginal examinations and GBS colonization.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 5, 2020
• Est. primary completion date: September 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primigravida

• Gestational age = 37 weeks (according to 1st trimester sonography)

• Single fetus •Cephalic presentation

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Chorioamnionitis
• Fever
• Labor Complication
• Obstetric Labor Complications
• Pregnancy Related

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Israel	Maya Oberman	Re?ovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Benediktsdottir S, Eggebø TM, Salvesen KÅ. 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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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