Study of Ultrasound Imaging to Predict Time and Outcome in Pregnancies With Induced Labor
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|ClinicalTrials.gov Identifier: NCT00465998|
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : July 19, 2016
Last Update Posted : July 19, 2016
|Condition or disease|
|Pregnancy Labor, Induced|
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
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.
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Prediction of Labor and Delivery With the Use of Ultrasound in Pregnancies With Induced Labor|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
- Vaginal Delivery in Induced Labors [ Time Frame: Time from induction of labor to delivery ]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.
- Delivery Within 24 Hours [ Time Frame: Time from induction to delivery ]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.
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): NCT00465998
|Stavanger University Hospital|
|Stavanger, Norway, NO-4011|
|Study Director:||Kjell Å. Salvesen, Prof. PhD||St. Olavs Hospital|