NCT01610453

Brief Summary

Objectives

  1. 1.To assess if head-perineum distance and angle of progression measured with transperineal ultrasound by the obstetrician on call can predict delivery mode in primiparous women with prolonged first stage of labour.
  2. 2.To compare ultrasound assessments and clinical examinations.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
4 countries

6 active sites

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, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 27, 2016

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

February 10, 2012

Results QC Date

April 25, 2016

Last Update Submit

April 26, 2016

Conditions

Failed Labor

Keywords

prolonged laborcesarean sectionduration of labor

Outcome Measures

Primary Outcomes (1)

  • Percentage of Women With Vaginal Deliveries

    Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance (HPD) ≤40 mm and angle of progression (AoP) ≥110 degrees were used as cut-off level. HPD was obtained in all 150 cases and AoP was successfully obtained in 145 cases.

    active labor

Secondary Outcomes (1)

  • Percentage of Women With Cesarean Section

    active labor

Study Arms (1)

ultrasound

primiparous women with prolonged labours will be eligible for examination

Procedure: ultrasound examination

Interventions

ultrasound examinationPROCEDURE

transabdominal and transperineal ultrasound examinations

ultrasound

Eligibility Criteria

Age15 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

primiparous women in labor

You may qualify if:

  • Primiparous women with single pregnancies and gestation age \> 37 weeks and prolonged first stage of labor

You may not qualify if:

  • High risk pregnancies,
  • premature deliveries,
  • multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hvidovre Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Haukeland University Hospital

Bergen, 5000, Norway

Location

Stavanger University Hospital

Stavanger, 4068, Norway

Location

St.Olavs Hospital

Trondheim, 7000, Norway

Location

Skåne University Hospital

Malmo, 20052, Sweden

Location

Addenbrooke's Hospital

Cambridge, CB2 2QQ, United Kingdom

Location

Related Publications (5)

  • 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: 21308837BACKGROUND

  • 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: 19248000BACKGROUND

  • Akmal S, Tsoi E, Kametas N, Howard R, Nicolaides KH. Intrapartum sonography to determine fetal head position. J Matern Fetal Neonatal Med. 2002 Sep;12(3):172-7. doi: 10.1080/jmf.12.3.172.177.

    PMID: 12530614BACKGROUND

  • Eggebo TM, Hassan WA, Salvesen KA, Lindtjorn E, Lees CC. Sonographic prediction of vaginal delivery in prolonged labor: a two-center study. Ultrasound Obstet Gynecol. 2014 Feb;43(2):195-201. doi: 10.1002/uog.13210. Epub 2013 Dec 22.

    PMID: 24105705RESULT

  • Eggebo TM, Hassan WA, Salvesen KA, Torkildsen EA, Ostborg TB, Lees CC. Prediction of delivery mode by ultrasound-assessed fetal position in nulliparous women with prolonged first stage of labor. Ultrasound Obstet Gynecol. 2015 Nov;46(5):606-10. doi: 10.1002/uog.14773. Epub 2015 Sep 28.

    PMID: 25536955RESULT

Results Point of Contact

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

Study Officials

  • Torbjørn M Eggebø, PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

February 10, 2012

First Posted

June 4, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 27, 2016

Results First Posted

April 27, 2016

Record last verified: 2016-04

Locations

NO(3)SE(1)DK(1)GB(1)