Ultrasound Prediction of Prolonged Labour
First Stage 3D-ultrasound During Prolonged Labour.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Stavanger, Norge, NO-4011
- Stavanger University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Primi gravidae
- >37th week
- Cephalic presentation
- Prolonged first stage according to WHO definitions.
Exclusion Criteria:
- Multiple pregnancies
- Intrauterine fetal death
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)
Tidsramme: 6 hours post determination of prolonged labor
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6 hours post determination of prolonged labor
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Erik Andreas Torkildsen, MD, Helse Stavanger HF
- Studieleder: Torbjørn Moe Eggebø, MD, PhD, Helse Stavanger HF
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- StaHF500804
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