An interventional study of Transperineal Ultrasound in Pregnancy Related, Fever and Chorioamnionitis, sponsored by Kaplan Medical Center. Completed at 1 site in Israel. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-03.
Sponsored by Kaplan Medical Center · Not applicable, Interventional, and Prevention
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.
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.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's enrollment of 180 is above the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →Kaplan Medical Center is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
o Other known active infection (such as URTI, UTI)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Labor progress assessed by US, avoiding digital exams as much as possible;
Other: Transperineal Ultrasound
Labor progress assessed according to the regular protocol
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.
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.
Time frame: 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
Time frame: From admission to hospital until delivery
Ran from Aug 2019 to primary completion in Sep 2020, 12 months.
Of 66 non-industry interventional studies with no phase under Fever, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 12 months is below that.
Counting every sponsor, half of 74 studies reached it within 16 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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