Role of Intrapartum Ultrasound in Instrumental Delivery
Primary Purpose
Obstetric Labor Complications
Status
Terminated
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Transabdominal and transperineal ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstetric Labor Complications
Eligibility Criteria
Inclusion Criteria:
- pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound
- live singleton pregnancy
- fetus in a cephalic presentation
- in the second stage of labor, after the decision to perform an instrumental delivery
Exclusion Criteria:
- fetal malformations
- emergency situation
Sites / Locations
- Centro Hospitalar Lisboa Norte - Hospital Santa Maria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group
Control group
Arm Description
The study group will be constituted by pregnant women in whom the operative delivery will be preceded by a transabdominal and transperineal ultrasound to evaluate fetal head position and fetal head station, by means of determination of the 'angle of progression'.
The control group will be constituted by pregnant women in whom the operative delivery will be carried out based solely on clinical criteria, namely transvaginal digital examination.
Outcomes
Primary Outcome Measures
Maternal and neonatal morbidity
Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay
Neonatal morbidity
low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02899481
Brief Title
Role of Intrapartum Ultrasound in Instrumental Delivery
Official Title
Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Data Safety Monitoring Committee recommended stopping the trial due to futility.
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lisbon
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
Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor Complications
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
The study group will be constituted by pregnant women in whom the operative delivery will be preceded by a transabdominal and transperineal ultrasound to evaluate fetal head position and fetal head station, by means of determination of the 'angle of progression'.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will be constituted by pregnant women in whom the operative delivery will be carried out based solely on clinical criteria, namely transvaginal digital examination.
Intervention Type
Other
Intervention Name(s)
Transabdominal and transperineal ultrasound
Intervention Description
Transabdominal ultrasound, for determining fetal head position, is performed with the pregnant women in supine position after bladder emptying, with the transducer placed transversely on the suprapubic region of the maternal abdomen. For the sonographic determination of the fetal descent we will perform a transperineal ultrasound achieved by placing the ultrasound transducer on the perineum in a mid sagittal position between the labia below the pubic symphysis.
Primary Outcome Measure Information:
Title
Maternal and neonatal morbidity
Description
Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay
Time Frame
2 years
Title
Neonatal morbidity
Description
low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound
live singleton pregnancy
fetus in a cephalic presentation
in the second stage of labor, after the decision to perform an instrumental delivery
Exclusion Criteria:
fetal malformations
emergency situation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joana Barros, MD
Organizational Affiliation
University of Lisbon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar Lisboa Norte - Hospital Santa Maria
City
Lisbon
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
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Role of Intrapartum Ultrasound in Instrumental Delivery
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