Can Ultrasound Predict Labor Outcome in Operative Vaginal Deliveries?

NCT01878591 | Completed DMC

• 2 other identifiers: 2012/18652012/186
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

To assess whether ultrasound methods can predict outcome of operative vaginal deliveries in nulliparous women at term with singleton pregnancies and prolonged second stage of labor. To compare different ultrasound assessments Compare digital assessments and ultrasound findings. Investigate if movement of the fetal head during active pushing is a predictive factor Null hypotheses:

• Ultrasound measurements cannot predict outcomes of operative vaginal delivery.
• Ultrasound is not better than digital examination in predicting delivery outcome.
• Movement of fetal head with active pushing is not a predictive factor.

Conditions

Prolonged Labour

Keywords

labour; dystocia; operative delivery; vacuum; ultrasound

Outcome Measures

Primary Outcomes (1)

• Time from start of vacuum assisted traction to delivery

  The duration of a vacuum extraction will be measured. Therefore, the time frame is for this variable is only the second stage of labor. However, the time frame including all variables will be from the start of active second stage of labor - 1 hour after delivery.

  Active second stage of labor to1 hour after delivery

Secondary Outcomes (1)

• Successful/failed vaginal operative delivery (vaginal delivery vs. cesarean section

  Active second stage of labour

Other Outcomes (3)

• Apgar score

  first ten minutes after delivery

• ph and base excess in umibical cord

  first 5 minutes after delivery

• birth weight and head circumference

  First hour after delivery

Study Arms (1)

Women in active second stage of labour

Ultrasound examinations

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Nulliparous women with a singleton live fetus in cephalic presentation at term (≥ 37 weeks) with prolonged active second stage and a clinical decision to expedite delivery by vacuum due to poor progression

You may qualify if:

• prolonged second stage of labour

You may not qualify if:

• Suspected asphyxia before the start of vacuum extraction

Sponsors & Collaborators

• Helse Stavanger HF: lead
• St.Olavs Hospital, Trondheim University Hospital, Norway: collaborator
• Lund University Hospital: collaborator
• University of Bologna: collaborator
• Copenhagen University Hospital, Hvidovre: collaborator
• Queen Charlotte's and Chelsea Hospital: collaborator
• University of Parma: collaborator

Study Sites (1)

Stavanger University Hospital

Stavanger, 4313, Norway

Location

Related Publications (14)

• Hassan WA, Eggebo TM, Ferguson M, Lees C. Simple two-dimensional ultrasound technique to assess intrapartum cervical dilatation: a pilot study. Ultrasound Obstet Gynecol. 2013 Apr;41(4):413-8. doi: 10.1002/uog.12316.

  PMID: 23024020 BACKGROUND

• 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 BACKGROUND

• Torkildsen EA, Salvesen KA, VON Brandis P, Eggebo TM. Predictive value of ultrasound assessed fetal head position in primiparous women with prolonged first stage of labor. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1300-5. doi: 10.1111/j.1600-0412.2012.01503.x. Epub 2012 Aug 22.

  PMID: 22774859 BACKGROUND

• 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 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 BACKGROUND

• Eggebo TM, Okland I, Heien C, Gjessing LK, Romundstad P, Salvesen KA. Can ultrasound measurements replace digitally assessed elements of the Bishop score? Acta Obstet Gynecol Scand. 2009;88(3):325-31. doi: 10.1080/00016340902730417.

  PMID: 19172418 BACKGROUND

• 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

• 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

• Kalache KD, Duckelmann AM, Michaelis SA, Lange J, Cichon G, Dudenhausen JW. Transperineal ultrasound imaging in prolonged second stage of labor with occipitoanterior presenting fetuses: how well does the 'angle of progression' predict the mode of delivery? Ultrasound Obstet Gynecol. 2009 Mar;33(3):326-30. doi: 10.1002/uog.6294.

  PMID: 19224527 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

• Eggebo TM. Ultrasound is the future diagnostic tool in active labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):361-3. doi: 10.1002/uog.12417. No abstract available.

  PMID: 23641509 BACKGROUND

• Ghi T, Farina A, Pedrazzi A, Rizzo N, Pelusi G, Pilu G. Diagnosis of station and rotation of the fetal head in the second stage of labor with intrapartum translabial ultrasound. Ultrasound Obstet Gynecol. 2009 Mar;33(3):331-6. doi: 10.1002/uog.6313.

  PMID: 19202576 BACKGROUND

• Ghi T, Youssef A, Maroni E, Arcangeli T, De Musso F, Bellussi F, Nanni M, Giorgetta F, Morselli-Labate AM, Iammarino MT, Paccapelo A, Cariello L, Rizzo N, Pilu G. Intrapartum transperineal ultrasound assessment of fetal head progression in active second stage of labor and mode of delivery. Ultrasound Obstet Gynecol. 2013 Apr;41(4):430-5. doi: 10.1002/uog.12379.

  PMID: 23288706 BACKGROUND

• Youssef A, Maroni E, Ragusa A, De Musso F, Salsi G, Iammarino MT, Paccapelo A, Rizzo N, Pilu G, Ghi T. Fetal head-symphysis distance: a simple and reliable ultrasound index of fetal head station in labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):419-24. doi: 10.1002/uog.12335. Epub 2013 Mar 6.

  PMID: 23124698 BACKGROUND

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Torbjørn M Eggebø, phd

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 9, 2013
• First Posted: June 17, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)