Clinical trial NCT00465998: Study of Ultrasound Imaging to Predict Time and Outcome in Pregnancies With Induced Labor
Official title: Prediction of Labor and Delivery With the Use of Ultrasound in Pregnancies With Induced Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Labor, Induced
Keywords: Ultrasound
Induced labor
Cervical length
Engagement of fetal head
Occiput posterior
Outcome of labor
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Norwegian University of Science and Technology
name: St. Olavs Hospital
First posted: 2007-04-27
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant females with indication for induced labor

Brief 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.

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 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

Primary outcomes:
measure: Vaginal Delivery in Induced Labors
timeFrame: Time from induction of labor to delivery
Secondary outcomes:
measure: Delivery Within 24 Hours
timeFrame: Time from induction to delivery
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Kjell Å. Salvesen, Prof. PhD
role: STUDY_DIRECTOR
References:
citation: BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
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. doi: 10.1002/uog.1100.
citation: Dietz HP, Lanzarone V, Simpson JM. Predicting operative delivery. Ultrasound Obstet Gynecol. 2006 Apr;27(4):409-15. doi: 10.1002/uog.2731.
citation: Eggebo TM, Gjessing LK, Heien C, Smedvig E, Okland 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. doi: 10.1002/uog.2744.
citation: Eggebo TM, Okland 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.
citation: Eggebo TM, Heien C, Okland 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.