Pregnancy Related Clinical Trial
Official title:
Assessment of Labour Progress by Intrapartum Ultrasound: Can it Reduce the Incidence of Chorioamnionitis?
Verified date | December 2020 |
Source | Kaplan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Maya Oberman | Re?ovot |
Lead Sponsor | Collaborator |
---|---|
Kaplan Medical Center |
Israel,
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
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 |
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