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

Pregnancy Clinical Trial

Official title:

Prediction of Labor and Delivery With the Use of Ultrasound in Pregnancies With Induced Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465998
• Other study ID #: StaHF483201
• Secondary ID: Helse Vest 91131
• Status: Completed
• Phase: N/A
• First received: April 25, 2007
• Last updated: July 27, 2015
• Start date: January 2006
• Est. completion date: March 2007

Study information

• Verified date: August 2010
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial Summary

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.

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 250 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Labor, Induced
• Pregnancy

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (3)

Lead Sponsor	Collaborator
Helse Stavanger HF	Norwegian University of Science and Technology, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (6)

BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. — View Citation

Dietz HP, Lanzarone V, Simpson JM. Predicting operative delivery. Ultrasound Obstet Gynecol. 2006 Apr;27(4):409-15. — View Citation

Eggebø TM, Gjessing LK, Heien C, Smedvig E, Økland I, Romundstad P, Salvesen KA. Prediction of labor and delivery by transperineal ultrasound in pregnancies with prelabor rupture of membranes at term. Ultrasound Obstet Gynecol. 2006 Apr;27(4):387-91. — View Citation

Eggebø TM, Heien C, Økland I, Gjessing LK, Romundstad P, Salvesen KA. Ultrasound assessment of fetal head-perineum distance before induction of labor. Ultrasound Obstet Gynecol. 2008 Aug;32(2):199-204. doi: 10.1002/uog.5360. — View Citation

Eggebø TM, Økland I, Heien C, Gjessing LK, Romundstad P, Salvesen KA. Can ultrasound measurements replace digitally assessed elements of the Bishop score? Acta Obstet Gynecol Scand. 2009;88(3):325-31. doi: 10.1080/00016340902730417. — View Citation

Rane SM, Guirgis RR, Higgins B, Nicolaides KH. The value of ultrasound in the prediction of successful induction of labor. Ultrasound Obstet Gynecol. 2004 Oct;24(5):538-49. — View Citation