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Pregnancy RelatedNCT04651309

Assessment of Labour Progress by Intrapartum Ultrasound

A study testing Transperineal Ultrasound in people with Pregnancy Related and Fever, run by Kaplan Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related, Fever, Chorioamnionitis
What is being tested?
Transperineal Ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteIsrael
Study dates
27 Aug 2019to 5 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Maya Oberman

    Rehovot, 123456

Other trials in Israel

About this study

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

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.

Read the detailed 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.

Being tested
Transperineal Ultrasound
Medical subject headings
Fever, Chorioamnionitis, Obstetric Labor Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transperineal UltrasoundOther

    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.

Study groups in NCT04651309
Study groupRoleWhat they receive
Ultrasound groupOtherLabor progress assessed by US, avoiding digital exams as much as possible;
Receives: Other: Transperineal Ultrasound
Control groupNo interventionLabor progress assessed according to the regular protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Number of digital exams in each of the study arms

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

    Measured: From admission to hospital until delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study start27 Aug 2019
  3. Primary completion5 Sep 2020
  4. Study completion5 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04651309
Sponsor's protocol ID
0118-17-KMC
Status last verified
Dec 2020
First submitted
15 Nov 2020
Last updated
3 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 9396886

  • 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.

    PubMed 26496894

  • 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.

    PubMed 25846302

  • 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.

    PubMed 24105734

  • 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.

    PubMed 27300158

  • 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.

    PubMed 36400420

  • 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.

    PubMed 36396038

Questions about this trial

What is this clinical trial studying?

A study testing Transperineal Ultrasound in people with Pregnancy Related and Fever, run by Kaplan Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fever and infection rates in each of the study arms (time frame: From admission to hospital for labor until 2 week post-partum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04651309, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.

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