NCT00465998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

July 19, 2016

Completed
Last Updated

July 19, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

April 25, 2007

Results QC Date

April 28, 2016

Last Update Submit

June 7, 2016

Conditions

PregnancyLabor, Induced

Keywords

UltrasoundInduced laborCervical lengthEngagement of fetal headOcciput posteriorOutcome of labor

Outcome Measures

Primary Outcomes (1)

  • Vaginal Delivery in Induced Labors

    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.

    Time from induction of labor to delivery

Secondary Outcomes (1)

  • Delivery Within 24 Hours

    Time from induction to delivery

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant females with indication for induced labor

You may qualify if:

  • Pregnancy
  • Indication of induced labor

You may not qualify if:

  • More than one fetus
  • Less than 37 weeks of pregnancy
  • Previous cesarean section
  • Breach position
  • Dead fetus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, NO-4011, Norway

Location

Related Publications (6)

  • BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.

    PMID: 14199536BACKGROUND

  • 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.

    PMID: 15386612BACKGROUND

  • Dietz HP, Lanzarone V, Simpson JM. Predicting operative delivery. Ultrasound Obstet Gynecol. 2006 Apr;27(4):409-15. doi: 10.1002/uog.2731.

    PMID: 16565982BACKGROUND

  • 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.

    PMID: 16565994BACKGROUND

  • 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.

    PMID: 19172418BACKGROUND

  • 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.

    PMID: 18528923BACKGROUND

Results Point of Contact

Title
Professor Torbjørn Moe Eggebø
Organization
Stavanger University Hospital
tme@lyse.net
+4792699433

Study Officials

  • Kjell Å. Salvesen, Prof. PhD

    St. Olavs Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

January 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

July 19, 2016

Results First Posted

July 19, 2016

Record last verified: 2016-06

Locations

NO(1)