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Assessment of Labour Progress by Intrapartum Ultrasound

Primary Purpose

Pregnancy Related, Fever, Chorioamnionitis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Transperineal Ultrasound
Sponsored by
Kaplan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Related

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maya Oberman

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Ultrasound group

Control group

Arm Description

Labor progress assessed by US, avoiding digital exams as much as possible;

Labor progress assessed according to the regular protocol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 15, 2020
Last Updated
December 2, 2020
Sponsor
Kaplan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04651309
Brief Title
Assessment of Labour Progress by Intrapartum Ultrasound
Official Title
Assessment of Labour Progress by Intrapartum Ultrasound: Can it Reduce the Incidence of Chorioamnionitis?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
September 5, 2020 (Actual)
Study Completion Date
September 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaplan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Fever, Chorioamnionitis, Labor Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound group
Arm Type
Other
Arm Description
Labor progress assessed by US, avoiding digital exams as much as possible;
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Labor progress assessed according to the regular protocol
Intervention Type
Other
Intervention Name(s)
Transperineal Ultrasound
Intervention Description
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 Outcome Measure Information:
Title
Fever and infection rates in each of the study arms
Description
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
Title
Number of digital exams in each of the study arms
Description
The number of digital exams will be counted in each of the study arms
Time Frame
From admission to hospital until delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Oberman, MD
Organizational Affiliation
Kaplan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maya Oberman
City
Reẖovot
ZIP/Postal Code
123456
Country
Israel

12. IPD Sharing Statement

Citations:
Citation
Gabbe, Steven G, Obstetrics: normal and problem pregnancies , Seventh edition. ..2017
Results Reference
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PubMed Identifier
9396886
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. doi: 10.1016/s0002-9378(97)70007-3.
Results Reference
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PubMed Identifier
26496894
Citation
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.
Results Reference
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PubMed Identifier
25846302
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.
Results Reference
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PubMed Identifier
24105734
Citation
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.
Results Reference
background
PubMed Identifier
27300158
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.
Results Reference
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Assessment of Labour Progress by Intrapartum Ultrasound

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