Ultrasound Prediction of Prolonged Labour

NCT00915148 | Completed Results

• 1 other identifier: StaHF500804
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is designed to correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically, the study will evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.

Conditions

Prolonged Labor

Keywords

Prolonged labor; Ultrasound; Caeserian section

Outcome Measures

Primary Outcomes (1)

• Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound

  Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.

  during labor

Secondary Outcomes (1)

• Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)

  6 hours post determination of prolonged labor

Study Arms (1)

Ultrasound examination

Women with prolonged Labour; Primi gravidae, single pregnancy, \>37 weeks, fetus alive, cephalic presentation.

Other: Ultrasound examination

Interventions

Ultrasound examination OTHER

Trans-abdominal and trans-perineal 3D ultrasound examination

Ultrasound examination

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primi gravidae, with one fetus, after the 37th week. Cephalic presentation. Prolonged first stage according to WHO definitions.

You may qualify if:

• Primi gravidae
• \>37th week
• Cephalic presentation
• Prolonged first stage according to WHO definitions.

You may not qualify if:

• Multiple pregnancies
• Intrauterine fetal death

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, NO-4011, Norway

Location

Related Publications (8)

• 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: 18528923 BACKGROUND

• Eggebo TM, Heien C, Okland I, Gjessing LK, Smedvig E, Romundstad P, Salvesen KA. Prediction of labour and delivery by ascertaining the fetal head position with transabdominal ultrasound in pregnancies with prelabour rupture of membranes after 37 weeks. Ultraschall Med. 2008 Apr;29(2):179-83. doi: 10.1055/s-2007-963017. Epub 2007 Jun 28.

  PMID: 17599279 BACKGROUND

• 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: 16565994 BACKGROUND

• Barbera AF, Pombar X, Perugino G, Lezotte DC, Hobbins JC. A new method to assess fetal head descent in labor with transperineal ultrasound. Ultrasound Obstet Gynecol. 2009 Mar;33(3):313-9. doi: 10.1002/uog.6329.

  PMID: 19248000 BACKGROUND

• Henrich W, Dudenhausen J, Fuchs I, Kamena A, Tutschek B. Intrapartum translabial ultrasound (ITU): sonographic landmarks and correlation with successful vacuum extraction. Ultrasound Obstet Gynecol. 2006 Nov;28(6):753-60. doi: 10.1002/uog.3848.

  PMID: 17063455 BACKGROUND

• Torkildsen EA, Salvesen KA, Eggebo TM. Prediction of delivery mode with transperineal ultrasound in women with prolonged first stage of labor. Ultrasound Obstet Gynecol. 2011 Jun;37(6):702-8. doi: 10.1002/uog.8951. Epub 2011 May 3.

  PMID: 21308837 RESULT

• Tutschek B, Torkildsen EA, Eggebo TM. Comparison between ultrasound parameters and clinical examination to assess fetal head station in labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):425-9. doi: 10.1002/uog.12422. Epub 2013 Mar 14.

  PMID: 23371409 RESULT

• Torkildsen EA, Salvesen KA, Eggebo TM. Agreement between two- and three-dimensional transperineal ultrasound methods in assessing fetal head descent in the first stage of labor. Ultrasound Obstet Gynecol. 2012 Mar;39(3):310-5. doi: 10.1002/uog.9065.

  PMID: 21630362 RESULT

Results Point of Contact

• Title: Torbjørn Moe Eggebø, phd
• Organization: Stavanger UH

tme@lyse.net

004792699433

Study Officials

• Erik Andreas Torkildsen, MD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

• Torbjørn Moe Eggebø, MD, PhD

  Helse Stavanger HF

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: November 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 26, 2016
• Results First Posted: April 26, 2016

Record last verified: 2016-04

Locations

NO (1)