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Can Ultrasound Predict Labor Outcome in Operative Vaginal Deliveries?

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: NCT01878591
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : October 28, 2016
Sponsor:
Collaborators:
St.Olavs Hospital, Trondheim University Hospital, Norway
Lund University Hospital
University of Bologna
Copenhagen University Hospital, Hvidovre
Queen Charlotte's and Chelsea Hospital
University of Parma
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:

To assess whether ultrasound methods can predict outcome of operative vaginal deliveries in nulliparous women at term with singleton pregnancies and prolonged second stage of labor.

To compare different ultrasound assessments Compare digital assessments and ultrasound findings. Investigate if movement of the fetal head during active pushing is a predictive factor

Null hypotheses:

  • Ultrasound measurements cannot predict outcomes of operative vaginal delivery.
  • Ultrasound is not better than digital examination in predicting delivery outcome.
  • Movement of fetal head with active pushing is not a predictive factor.

Condition or disease
Prolonged Labour

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 223 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Ultrasound Predict Labor Outcome in Operative Vaginal Deliveries?
Study Start Date : November 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort
Women in active second stage of labour
Ultrasound examinations



Primary Outcome Measures :
  1. Time from start of vacuum assisted traction to delivery [ Time Frame: Active second stage of labor to1 hour after delivery ]
    The duration of a vacuum extraction will be measured. Therefore, the time frame is for this variable is only the second stage of labor. However, the time frame including all variables will be from the start of active second stage of labor - 1 hour after delivery.


Secondary Outcome Measures :
  1. Successful/failed vaginal operative delivery (vaginal delivery vs. cesarean section [ Time Frame: Active second stage of labour ]
    Successful or failed operative deliveries will be recorded. The time frame is also for this variable only the second stage of labor.


Other Outcome Measures:
  1. Apgar score [ Time Frame: first ten minutes after delivery ]
    Apgar score is assessed after 1,5 and 10 minutes

  2. ph and base excess in umibical cord [ Time Frame: first 5 minutes after delivery ]
    blood test from the umbilical board

  3. birth weight and head circumference [ Time Frame: First hour after delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Nulliparous women with a singleton live fetus in cephalic presentation at term (≥ 37 weeks) with prolonged active second stage and a clinical decision to expedite delivery by vacuum due to poor progression
Criteria

Inclusion Criteria:

  • prolonged second stage of labour

Exclusion Criteria:

  • Suspected asphyxia before the start of vacuum extraction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878591


Locations
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Norway
Stavanger University Hospital
Stavanger, Norway, 4313
Sponsors and Collaborators
Helse Stavanger HF
St.Olavs Hospital, Trondheim University Hospital, Norway
Lund University Hospital
University of Bologna
Copenhagen University Hospital, Hvidovre
Queen Charlotte's and Chelsea Hospital
University of Parma
Investigators
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Principal Investigator: Torbjørn M Eggebø, phd Helse Stavanger HF
Publications:

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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01878591    
Other Study ID Numbers: 2012/1865
2012/186 ( Other Identifier: REK-VEST )
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helse Stavanger HF:
labour
dystocia
operative delivery
vacuum
ultrasound