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Completed

NCT Number: NCT00465998

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

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Stavanger University Hospital

Stavanger, NO-4011, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Norwegian University of Science and Technology
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 27, 2007
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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