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Ultrasound Prediction of Prolonged Labour

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ClinicalTrials.gov Identifier: NCT00915148
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Prolonged Labor
Intervention Other: Ultrasound examination
Enrollment 110
Recruitment Details Medical contact during10 months
Pre-assignment Details No participants were excluded
Arm/Group Title Women With Prolonged Labour
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 110 [1]
Completed 110 [2]
Not Completed 0
[1]
October 2009
[2]
August 2010
Arm/Group Title Women With Prolonged Labour
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Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.

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

Overall Number of Baseline Participants 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
<=18 years
0
   0.0%
Between 18 and 65 years
110
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 110 participants
29
(18 to 41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Female
110
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 110 participants
110
1.Primary Outcome
Title Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound
Hide Description Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.
Time Frame during labor
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women With Prolonged Labour
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage probability
2D fetal head-perineum distance (AUC)
81
(71 to 91)
2D angle of progression (AUC)
76
(66 to 87)
3D fetal head-perineum distance
80
(70 to 90)
3D angle of progression (AUC)
76
(65 to 86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women With Prolonged Labour
Comments In a previous study we investigated women before induction of labor. Using 40 mm as cut-off level for fetal head – perineum distance, the Cesarean section rate in primiparous women was 7% in the group with a short distance and 27% in the group with a long distance. We assumed similar results, with alpha 0.05, power 0.8 and a ratio of 1 : 1 for the numbers of women with a long and short distance. We would need to include 110 women in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The reported p-value corresponds with each area under the ROC assessments
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)
Hide Description [Not Specified]
Time Frame 6 hours post determination of prolonged labor
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women Delivered Within 6 Hours
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Nulliparous women, single pregnancy, > 37 weeks of pregnancy, fetus alive and cephalic presentation.

Ultrasound examinations: 2D transperineal scan

Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: percentage of participants
Fetal head-perineum distance ≤40 mm (n=54) 74
Fetal head-perineum distance >40 mm (n=56) 39
Angle of progression ≥110 degrees (n=53) 72
Angle of progression <110 degrees (n=57) 44
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Women Delivered Within 6 Hours
Comments

Kaplan Meier plots were used to compare time from a defined prolonged labor in the first stage to delivery for

  1. women with fetal head-perineum distance ≤40 mm vs. women with distance >40 mm measured with 2D ultrasound.
  2. women with angle of progression ≥110 degrees vs. women with angle <110 degrees measured with 2D ultrasound
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments the reported p-value corresponds with each log rank comparison
Method Log Rank
Comments [Not Specified]
Time Frame 1 week
Adverse Event Reporting Description Eventual adverse outcomes were investigated during the postpartum period
 
Arm/Group Title Women With Prolonged Labour
Hide Arm/Group Description

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

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

All-Cause Mortality
Women With Prolonged Labour
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Women With Prolonged Labour
Affected / at Risk (%)
Total   0/110 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Women With Prolonged Labour
Affected / at Risk (%)
Total   0/110 (0.00%) 
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
EMail: tme@lyse.net
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00915148     History of Changes
Other Study ID Numbers: StaHF500804
First Submitted: June 3, 2009
First Posted: June 5, 2009
Results First Submitted: August 21, 2015
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016