Ultrasound Prediction of Prolonged Labour

Prolonged Labor Clinical Trial

Official title:

First Stage 3D-ultrasound During Prolonged Labour.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915148
• Other study ID #: StaHF500804
• Status: Completed
• Phase: N/A
• First received: June 3, 2009
• Last updated: April 25, 2016
• Start date: November 2008
• Est. completion date: August 2010

Study information

• Verified date: April 2016
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

Description:

AIM:

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

Objective:

Labours have traditionally been evaluated by manuals methods of the "delivery helper" - midwives or doctor. There are many factors that will prolong labour such as malcontractions, disproportion of the birth canal and malpresentation/position. In about 20% of primigravidae, the first stage will last longer than 10 hours.

In this study we want to evaluate different ultrasounds measurements to see if ultrasound can be used to predict the outcome of labour.

Methods:

A descriptive observational study, with one ultrasound examination. The labour will be handled according to definitions by Woman's department, Stavanger University Hospital, and WHO.

The use of stimulating agents, as Oxytocin, will be evaluated after manual examinations, specific definitions and criteria.

The results of the ultrasound examinations will be evaluated after the delivery, since the results are not to be used clinically during the delivery.

Inclusion criteria will be primigravidae, with one fetus, after the 37th week. Feta head presentation. Ruptured membranes, at least one hour before inclusion. Prolonged first stage according to WHO definitions. The target is to include 100 subjects.

Inter- and intraobserver variation will be evaluated with intraclass coefficients. We will analyze operative delivery with normal vaginal delivery. Also, two groups divided by the stage 0 will be evaluated with statistics analyzes.

Time to delivery will be evaluated with Kaplan Meier and Cox regression analyzes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primi gravidae

• >37th week

• Cephalic presentation

• Prolonged first stage according to WHO definitions.

Exclusion Criteria:

• Multiple pregnancies

• Intrauterine fetal death

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prolonged Labor

Intervention

Other:
• Ultrasound examination
Trans-abdominal and trans-perineal 3D ultrasound examination

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

References & Publications (8)

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. — View Citation

Eggebø TM, Gjessing LK, Heien C, Smedvig E, Økland 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. — View Citation

Eggebø TM, Heien C, Økland 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. — View Citation

Eggebø 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. Epub 2007 Jun 28. — View Citation

Henrich W, Dudenhausen J, Fuchs I, Kämena A, Tutschek B. Intrapartum translabial ultrasound (ITU): sonographic landmarks and correlation with successful vacuum extraction. Ultrasound Obstet Gynecol. 2006 Nov;28(6):753-60. — View Citation

Torkildsen EA, Salvesen KÅ, Eggebø 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. — View Citation

Torkildsen EA, Salvesen KÅ, Eggebø 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. — View Citation

Tutschek B, Torkildsen EA, Eggebø 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)		6 hours post determination of prolonged labor	Yes