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Study of Ultrasound Imaging to Predict Time and Outcome in Pregnancies With Induced Labor

This study has been completed.
Sponsor:
Collaborators:
Norwegian University of Science and Technology
St. Olavs Hospital
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00465998
First received: April 25, 2007
Last updated: June 7, 2016
Last verified: June 2016
  Purpose
The aim of the study was to evaluate any possible associations between engagement and position of the fetal head and the outcome of labor in women with induced labor, and to compare the value of ultrasound measurements in predicting the time from induction to delivery and operative deliveries.

Condition
Pregnancy
Labor, Induced

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction of Labor and Delivery With the Use of Ultrasound in Pregnancies With Induced Labor

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Vaginal Delivery in Induced Labors [ Time Frame: Time from induction of labor to delivery ] [ Designated as safety issue: No ]
    The association between Bishop score, ultrasound assessed fetal station, ultrasound assessed cervical length, cervical posterior angle and a vaginal delivery was investigated using area under the ROC curves. Fetal station was assessed by ultrasound as the fetal head-perineum distance (HPD); which was measured by transperineal ultrasound imaging as the shortest distance from the outer bony limit of the fetal skull to the skin surface of the perineum.


Secondary Outcome Measures:
  • Delivery Within 24 Hours [ Time Frame: Time from induction to delivery ] [ Designated as safety issue: No ]
    Association between parity, HPD, cervical length, cervical angle, occiput posterior position, parity, BMI and the Hazard ratio of delivering within 24 hours was investigated using Cox regression analysis.


Enrollment: 250
Study Start Date: January 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Fetal head engagement measured by ultrasound as a predictive factor of labor outcome in women with induced labor

T. EGGEBØ, L. K. GJESSING, I. ØKLAND, C. HEIEN, P. ROMUNDSTAD*, K. Å. SALVESEN** Department of Obstetrics and Gynaecology, Stavanger University Hospital, Norway * Department of Public Health, NTNU, Norway, St Olavs Hospital, Trondheim University Hospital

** National Center for Fetal Medicine, Department of Obstetrics and Gynaecology, Trondheim University Hospital (St. Olav's Hospital) and Department of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology

KEYWORDS:

Ultrasound, induced labor, cervical length, engagement of fetal head, occiput posterior, Bishop score, outcome of labor

Objective The aim of the study is to evaluate any possible associations between engagement of the fetal head, the cervical status or occiput posterior position and the outcome of labor in women with induced labor, and to compare the value of ultrasound measurements with Bishop score in predicting operative deliveries.

Methods The ultrasound examinations will be carried out in 275 women immediately before induction of labor. A transabdominal scan will be performed to determine the position of the fetal occiput, a transperineal scan with transverse view to determine the degree of engagement and a transvaginal examination to evaluate the cervical length and the cervical angle.. The Bishop score will be performed by another examinator who is blinded to the results of the ultrasound examinations. The time from induction to delivery will be tested in a Cox regression analysis with fetal head engagement, cervical length and parity as possible predictive factors and maternal age, BMI, gestational age, birth weight and head circumference as possible confounders.

Inclusion and exclusion criteria:

Women were eligible for the study if they had a live singleton pregnancy with cephalic presentation and a gestational age of more than 37 completed pregnancy weeks according to a mid-trimester scan.

Statistical analysis Appropriate statistical tests for comparisons, such as Mann Whitney U test, chi-square test, Fisher`s exact test, Pearson correlation, Kaplan Meier survival analysis and Cox regression analysis will be used. For receiver-operating characteristics (ROC) curves, the area under the curve will be used as discriminator. P-values < 0.05 will be considered significant.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant females with indication for induced labor
Criteria

Inclusion Criteria:

  • Pregnancy
  • Indication of induced labor

Exclusion Criteria:

  • More than one fetus
  • Less than 37 weeks of pregnancy
  • Previous cesarean section
  • Breach position
  • Dead fetus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465998

Locations
Norway
Stavanger University Hospital
Stavanger, Norway, NO-4011
Sponsors and Collaborators
Helse Stavanger HF
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Kjell Å. Salvesen, Prof. PhD St. Olavs Hospital
  More Information

Publications:
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00465998     History of Changes
Other Study ID Numbers: StaHF483201  Helse Vest 911314 
Study First Received: April 25, 2007
Results First Received: April 28, 2016
Last Updated: June 7, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Helse Stavanger HF:
Ultrasound
Induced labor
Cervical length
Engagement of fetal head
Occiput posterior
Outcome of labor

ClinicalTrials.gov processed this record on September 30, 2016