Prolonged LabourNCT01878591
Can Ultrasound Predict Labor Outcome in Operative Vaginal Deliveries?
An observational study of Prolonged Labour, run by Helse Stavanger HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolonged Labour
- How many people
- 223 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2013to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- prolonged second stage of labour
Who cannot join
- Suspected asphyxia before the start of vacuum extraction
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The physician responsible for the labor will perform digital examinations (fetal station and position and cervical dilatation). Fetal station will be related to the ischial spine from -5 to +4 as described by WHO and illustrated in Figure 111. Another obstetrician or midwife blinded to the results from the clinical examination will perform the ultrasound measurements. The physician responsible for the labor will be blinded to the ultrasound measurements.
Ultrasound examinations between contractions
Due to considerations described below, only one recording/acquisition will be performed of each of the following:
- Head position B) Head-perineum distance C) Midline angle D) Angle of progression E) 3D sagittal transperineal acquisition In addition single scans are performed during active pushing as described under B) and D) (and a 3D sagittal scan when possible).
- Head position Position will be assessed in 2D with a transabdominal scan as described by Akmal4 and 3D in a transperineal scan as described by Ghi et al22. Fetal head position will be recorded as a clock dividing the circle in 24 divisions
Positions ≥02.30 and ≤03.30 hours should be recorded as left occiput transverse and positions ≥08.30 and ≤09.30 as right occiput transverse. Positions >03.30 and <08.30 should be recorded as occiput posterior and positions >09.30 and <02.30 as occiput anterior.
Head-perineum distance will be assessed with transperineal ultrasound. The women will be examined lying flat (or almost flat) in bed with flexed hips and knees position. The bladder should be emptied immediately before the ultrasound examination.
Head-perineum distance will be measured as the shortest distance between the outer bony limit of the fetal skull and the perineum with a transabdominal transducer placed transperineally between the labia in a transverse view (posterior fourchette - posterior commissure of the labia minor)
Midline angle will be measured as described by Ghi22. In a transverse transperineal scan the angle between the midline of the fetal head and a sagittal line through the maternal pelvis will be measured. This recording will also be performed in a transverse scan.
Angle of progression will be measured as described by Barbera and Kalache as the angle between the long axis of the symphysis pubis and the tangent of the skull in a transperineal sagittal scan.
The following outcome variables will be recorded upon delivery Main outcome
- Time from start of vacuum assisted traction to delivery (the entire body is delivered) Secondary outcomes
- Number of contraction before delivery
- Number of cup detachments
- Successful/failed vaginal operative delivery
- Forceps applied/not applied
- Perineal tears
- APGAR score of newborn.
- Arterial umbilical cord blood pH and BD (base deficit) values.
- Position at delivery
Statistics:
The time interval between start of operative vaginal delivery and delivery will be evaluated for the fetal head-perineum distance and angle of progression using survival analyses (Kaplan-Meier analyses and Cox regression analyses).
Categorical variables will be analyzed using Chi-square test and Fischer exact test, and continuous variable will be analyzed using T-test or Mann-Whitney U-test.
The predictive values for a successful operative vaginal delivery will be evaluated using receiver-operating characteristics (ROC) curves. The area under the curve (AUC, - 95% CI) is considered to have discriminatory potential if the lower limit of the CI exceeded 0.5.
Ultrasound measurements, digital assessment of station and dilatation, induction of labor, maternal age, gestational age and birth weight will be analyzed in logistic regression analyses with vaginal delivery vs. cesarean section as dependent variable.
- Conditions
- Prolonged Labour
- Keywords
- labour, dystocia, operative delivery, vacuum, ultrasound
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women in active second stage of labour | Ultrasound examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Active second stage of labor to1 hour after delivery
Secondary outcomes (1)
Successful/failed vaginal operative delivery (vaginal delivery vs. cesarean section
Successful or failed operative deliveries will be recorded. The time frame is also for this variable only the second stage of labor.
Measured: Active second stage of labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Prolonged LabourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- St. Olavs Hospital, Lund University Hospital, University of Bologna, Copenhagen University Hospital, Hvidovre, Queen Charlotte's and Chelsea Hospital, University of Parma
- Responsible party
- Sponsor
- Investigators
- Torbjørn M Eggebø, phd, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878591
- Sponsor's protocol ID
- 2012/1865
- Other IDs
- 2012/186
- Status last verified
- Oct 2016
- First submitted
- 9 Jun 2013
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23024020Tutschek 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.
PubMed 23371409Torkildsen 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.
PubMed 22774859Torkildsen 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.
PubMed 21630362Torkildsen 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.
PubMed 21308837Eggebo 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.
PubMed 19172418Eggebo 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.
PubMed 18528923Henrich 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.
PubMed 17063455Kalache 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.
PubMed 19224527Barbera 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.
PubMed 19248000Eggebo 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.
PubMed 23641509Ghi 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.
PubMed 19202576Ghi 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.
PubMed 23288706Youssef 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.
PubMed 23124698
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Ultrasound Predict Labor Outcome in Operative Vaginal Deliveries?
- ClinicalTrials.gov ID
- NCT01878591
- Acronym / sponsor ID
- 2012/1865
- Conditions
- Prolonged Labour
- Keywords
- labour, dystocia, operative delivery, vacuum, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- St. Olavs Hospital, Lund University Hospital, University of Bologna, Copenhagen University Hospital, Hvidovre, Queen Charlotte's and Chelsea Hospital, University of Parma
- Study start
- Nov 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The physician responsible for the labor will perform digital examinations (fetal station and position and cervical dilatation). Fetal station will be related to the ischial spine from -5 to +4 as described by WHO and illustrated in Figure 111. Another obstetrician or midwife blinded to the results from the clinical examination will perform the ultrasound measurements. The physician responsible for the labor will be blinded to the ultrasound measurements.
Ultrasound examinations between contractions
Due to considerations described below, only one recording/acquisition will be performed of each of the following:
- Head position B) Head-perineum distance C) Midline angle D) Angle of progression E) 3D sagittal transperineal acquisition In addition single scans are performed during active pushing as described under B) and D) (and a 3D sagittal scan when possible).
- Head position Position will be assessed in 2D with a transabdominal scan as described by Akmal4 and 3D in a transperineal scan as described by Ghi et al22. Fetal head position will be recorded as a clock dividing the circle in 24 divisions
Positions ≥02.30 and ≤03.30 hours should be recorded as left occiput transverse and positions ≥08.30 and ≤09.30 as right occiput transverse. Positions >03.30 and <08.30 should be recorded as occiput posterior and positions >09.30 and <02.30 as occiput anterior.
Head-perineum distance will be assessed with transperineal ultrasound. The women will be examined lying flat (or almost flat) in bed with flexed hips and knees position. The bladder should be emptied immediately before the ultrasound examination.
Head-perineum distance will be measured as the shortest distance between the outer bony limit of the fetal skull and the perineum with a transabdominal transducer placed transperineally between the labia in a transverse view (posterior fourchette - posterior commissure of the labia minor)
Midline angle will be measured as described by Ghi22. In a transverse transperineal scan the angle between the midline of the fetal head and a sagittal line through the maternal pelvis will be measured. This recording will also be performed in a transverse scan.
Angle of progression will be measured as described by Barbera and Kalache as the angle between the long axis of the symphysis pubis and the tangent of the skull in a transperineal sagittal scan.
The following outcome variables will be recorded upon delivery Main outcome
- Time from start of vacuum assisted traction to delivery (the entire body is delivered) Secondary outcomes
- Number of contraction before delivery
- Number of cup detachments
- Successful/failed vaginal operative delivery
- Forceps applied/not applied
- Perineal tears
- APGAR score of newborn.
- Arterial umbilical cord blood pH and BD (base deficit) values.
- Position at delivery
Statistics:
The time interval between start of operative vaginal delivery and delivery will be evaluated for the fetal head-perineum distance and angle of progression using survival analyses (Kaplan-Meier analyses and Cox regression analyses).
Categorical variables will be analyzed using Chi-square test and Fischer exact test, and continuous variable will be analyzed using T-test or Mann-Whitney U-test.
The predictive values for a successful operative vaginal delivery will be evaluated using receiver-operating characteristics (ROC) curves. The area under the curve (AUC, - 95% CI) is considered to have discriminatory potential if the lower limit of the CI exceeded 0.5.
Ultrasound measurements, digital assessment of station and dilatation, induction of labor, maternal age, gestational age and birth weight will be analyzed in logistic regression analyses with vaginal delivery vs. cesarean section as dependent variable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women in active second stage of labour | – | –Ultrasound examinations |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- prolonged second stage of labour
Key exclusion criteria (1 listed)
- Suspected asphyxia before the start of vacuum extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time from start of vacuum assisted traction to delivery
Time frame: Active second stage of labor to1 hour after 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.
1 secondary outcome
Successful/failed vaginal operative delivery (vaginal delivery vs. cesarean section
Time frame: Active second stage of labour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Background: PubMed 23024020Hassan 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.
- Background: PubMed 23371409Tutschek 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.
- Background: PubMed 22774859Torkildsen 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.
- Background: PubMed 21630362Torkildsen 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.
- Background: PubMed 21308837Torkildsen 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.
- Background: PubMed 19172418Eggebo 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.
- Background: PubMed 18528923Eggebo 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.
- Background: PubMed 17063455Henrich 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.
- Background: PubMed 19224527Kalache 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.
- Background: PubMed 19248000Barbera 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.
- Background: PubMed 23641509Eggebo 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.
- Background: PubMed 19202576Ghi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torbjørn M Eggebø, phd principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolonged Labour, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from start of vacuum assisted traction to delivery (time frame: Active second stage of labor to1 hour after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878591, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.