Assessment of Labour Progress by Intrapartum Ultrasound

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.

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Key information

Conditions

Pregnancy Related Body Temperature Changes Chorioamnionitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Membranes, Premature Rupture Fever Labor Complication Obstetric Labor Complications Pathological Conditions, Signs and Symptoms Placenta Diseases Pregnancy Complications Signs and Symptoms Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maya Oberman

Rehovot, 123456, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Fever and infection rates in each of the study arms

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

Intrapartum and post partum fever rates will be evaluated in both the study and the control groups.
Number of digital exams in each of the study arms

Time frame: From admission to hospital until delivery

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

Sponsors and collaborators

Lead sponsor

Kaplan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Dec 3, 2020
Registry last updated: Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed