Ultrasound Prediction of Prolonged Labour
First Stage 3D-ultrasound During Prolonged Labour.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Stavanger, Noruega, NO-4011
- Stavanger University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Primi gravidae
- >37th week
- Cephalic presentation
- Prolonged first stage according to WHO definitions.
Exclusion Criteria:
- Multiple pregnancies
- Intrauterine fetal death
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Ultrasound examination
Women with prolonged Labour; Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.
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Trans-abdominal and trans-perineal 3D ultrasound examination
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound
Periodo de tiempo: during labor
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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.
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during labor
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)
Periodo de tiempo: 6 hours post determination of prolonged labor
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6 hours post determination of prolonged labor
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Erik Andreas Torkildsen, MD, Helse Stavanger HF
- Director de estudio: Torbjørn Moe Eggebø, MD, PhD, Helse Stavanger HF
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- StaHF500804
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