Ultrasound Prediction of Prolonged Labour

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00915148
First received: June 3, 2009
Last updated: April 25, 2016
Last verified: April 2016
Results First Received: August 21, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Prolonged Labor
Intervention: Other: Ultrasound examination

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Medical contact during10 months

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No participants were excluded

Reporting Groups
  Description
Women With Prolonged Labour

Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.

Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination


Participant Flow:   Overall Study
    Women With Prolonged Labour  
STARTED     110 [1]
COMPLETED     110 [2]
NOT COMPLETED     0  
[1] October 2009
[2] August 2010



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Women With Prolonged Labour

Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.

Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination


Baseline Measures
    Women With Prolonged Labour  
Number of Participants  
[units: participants]
  110  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     110  
>=65 years     0  
Age  
[units: years]
Median (Full Range)
  29  
  (18 to 41)  
Gender  
[units: participants]
 
Female     110  
Male     0  
Region of Enrollment  
[units: participants]
 
Norway     110  



  Outcome Measures
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1.  Primary:   Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound   [ Time Frame: during labor ]

2.  Secondary:   Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)   [ Time Frame: 6 hours post determination of prolonged labor ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Torbjørn Moe Eggebø, phd
Organization: Stavanger UH
phone: 004792699433
e-mail: tme@lyse.net


Publications of Results:
Other Publications:

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00915148     History of Changes
Other Study ID Numbers: StaHF500804
Study First Received: June 3, 2009
Results First Received: August 21, 2015
Last Updated: April 25, 2016
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics