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Role of Intrapartum Ultrasound in Instrumental Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02899481
Recruitment Status : Terminated (Data Safety Monitoring Committee recommended stopping the trial due to futility.)
First Posted : September 14, 2016
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Joana Barros, University of Lisbon

Tracking Information
First Submitted Date  ICMJE July 6, 2016
First Posted Date  ICMJE September 14, 2016
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2020)
  • Maternal and neonatal morbidity [ Time Frame: 2 years ]
    Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay
  • Neonatal morbidity [ Time Frame: 2 years ]
    low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2016)
Maternal and neonatal morbidity [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Intrapartum Ultrasound in Instrumental Delivery
Official Title  ICMJE Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Obstetric Labor Complications
Intervention  ICMJE Other: Transabdominal and transperineal ultrasound
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.
Study Arms  ICMJE
  • Experimental: Study group
    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'.
    Intervention: Other: Transabdominal and transperineal ultrasound
  • No Intervention: Control group
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 20, 2020)
222
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2016)
600
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02899481
Other Study ID Numbers  ICMJE CC-157
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joana Barros, University of Lisbon
Study Sponsor  ICMJE University of Lisbon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joana Barros, MD University of Lisbon
PRS Account University of Lisbon
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP