Vacuum Extraction; Failure, Affecting Fetus or NewbornRISPOSTANCT01991665
R. I. S. POS. T. A
A study testing Digital examination and Sonography evaluation in people with Vacuum Extraction; Failure, Affecting Fetus or Newborn and Persistent Occiput Posterior Position During Labor, run by University of Bologna at 1 site in Italy.
Trial summary
A failed operative vaginal delivery is associated with increased risk of maternal and perinatal complications. It is very important the determination of the fetal head position prior to instrumental delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vacuum Extraction; Failure, Affecting Fetus or Newborn, Persistent Occiput Posterior Position During Labor, Complication of Delivery
- What is being tested?
- Digital examination and Sonography evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Apr 2018
- Phase
- Interventional
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with singleton cephalic pregnancies at term (≥37 weeks' gestation), who require an instrumental delivery
Who cannot join
- under 18 years of age
- women with contraindications for vacuum delivery
- women with sonography evaluation of fetal head position before randomization
- fetal head station > +3
- discretion of the responsible obstetrician in cases where there is urgency due to suspected fetal compromise("fetal distress")
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi University Hospital, University of Bologna
Bologna, Emilia-Romagna, 40138
Tullio Ghi, 0516364411, tullio.ghi@aosp.bo.it
About this study
Official title: Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum
A failed operative vaginal delivery is associated with increased risk of maternal and perinatal complications. It is very important the determination of the fetal head position prior to instrumental delivery.
Generally,diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. There is a paucity of studies on the accuracy of digital examination but the general consensus is that reproducibility is low and diagnostic uncertainty remains high even for operators with much experience.
Read more
As the traditional clinical evaluation has many limitations, a new tool capable of increasing diagnostic objectivity and accuracy would be of great interest.
The aim of our study was to evaluate, in a prospective study, if the complementary use of ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may play a role in labor outcome.
- Conditions
- Vacuum Extraction; Failure, Affecting Fetus or Newborn, Persistent Occiput Posterior Position During Labor, Complication of Delivery
- Being tested
- Digital examination, Sonography evaluation
- Keywords
- Intrapartum Ultrasound, Vacuum, Occiput position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital examinationOther
Sonography evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Digital examination before instrumental delivery to determine fetal head station and position Receives: Other: Digital examination |
| Group B | Other | Digital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position Receives: Other: Digital examination; Other: Sonography evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries).
Measured: 2 years
Secondary outcomes (2)
Incidence of: neonatal trauma (cephalhaematoma, retinal haemorrhage, facial nerve palsy, brachial plexus injury and fractures), low Apgar scores, fetal acidosis or admission to the neonatal unit, shoulder dystocia
Measured: 2 years
Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vacuum Extraction; Failure, Affecting Fetus or NewbornStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tullio Ghi, University of Parma
- Investigators
- Tullio Ghi, Principal investigator, Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991665
- Sponsor's protocol ID
- OST-2013-50
- Acronym
- RISPOSTA
- Status last verified
- May 2017
- First submitted
- 17 Nov 2013
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Groutz A, Hasson J, Wengier A, Gold R, Skornick-Rapaport A, Lessing JB, Gordon D. Third- and fourth-degree perineal tears: prevalence and risk factors in the third millennium. Am J Obstet Gynecol. 2011 Apr;204(4):347.e1-4. doi: 10.1016/j.ajog.2010.11.019. Epub 2010 Dec 22.
PubMed 21183150Towner D, Castro MA, Eby-Wilkens E, Gilbert WM. Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med. 1999 Dec 2;341(23):1709-14. doi: 10.1056/NEJM199912023412301.
PubMed 10580069Dupuis O, Silveira R, Zentner A, Dittmar A, Gaucherand P, Cucherat M, Redarce T, Rudigoz RC. Birth simulator: reliability of transvaginal assessment of fetal head station as defined by the American College of Obstetricians and Gynecologists classification. Am J Obstet Gynecol. 2005 Mar;192(3):868-74. doi: 10.1016/j.ajog.2004.09.028.
PubMed 15746684Akmal S, Kametas N, Tsoi E, Hargreaves C, Nicolaides KH. Comparison of transvaginal digital examination with intrapartum sonography to determine fetal head position before instrumental delivery. Ultrasound Obstet Gynecol. 2003 May;21(5):437-40. doi: 10.1002/uog.103.
PubMed 12768552Ramphul M, Kennelly M, Murphy DJ. Establishing the accuracy and acceptability of abdominal ultrasound to define the foetal head position in the second stage of labour: a validation study. Eur J Obstet Gynecol Reprod Biol. 2012 Sep;164(1):35-9. doi: 10.1016/j.ejogrb.2012.06.001. Epub 2012 Jul 2.
PubMed 22762840Rozenberg P, Porcher R, Salomon LJ, Boirot F, Morin C, Ville Y. Comparison of the learning curves of digital examination and transabdominal sonography for the determination of fetal head position during labor. Ultrasound Obstet Gynecol. 2008 Mar;31(3):332-7. doi: 10.1002/uog.5267.
PubMed 18307213Zahalka N, Sadan O, Malinger G, Liberati M, Boaz M, Glezerman M, Rotmensch S. Comparison of transvaginal sonography with digital examination and transabdominal sonography for the determination of fetal head position in the second stage of labor. Am J Obstet Gynecol. 2005 Aug;193(2):381-6. doi: 10.1016/j.ajog.2004.12.011.
PubMed 16098859Wong GY, Mok YM, Wong SF. Transabdominal ultrasound assessment of the fetal head and the accuracy of vacuum cup application. Int J Gynaecol Obstet. 2007 Aug;98(2):120-3. doi: 10.1016/j.ijgo.2007.05.021. Epub 2007 Jun 22.
PubMed 17585916
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Italian Sonography for Occiput POSition Trial Ante Vacuum
- ClinicalTrials.gov ID
- NCT01991665
- Acronym / sponsor ID
- RISPOSTA / OST-2013-50
- Conditions
- Vacuum Extraction; Failure, Affecting Fetus or Newborn, Persistent Occiput Posterior Position During Labor, Complication of Delivery
- Keywords
- Intrapartum Ultrasound, Vacuum, Occiput position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 25 Nov 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.
A failed operative vaginal delivery is associated with increased risk of maternal and perinatal complications. It is very important the determination of the fetal head position prior to instrumental delivery.
Generally,diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. There is a paucity of studies on the accuracy of digital examination but the general consensus is that reproducibility is low and diagnostic uncertainty remains high even for operators with much experience.
As the traditional clinical evaluation has many limitations, a new tool capable of increasing diagnostic objectivity and accuracy would be of great interest.
The aim of our study was to evaluate, in a prospective study, if the complementary use of ultrasound scan, to diagnose the fetal head position prior to instrumental delivery, may play a role in labor outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: Digital examinationDigital examination before instrumental delivery to determine fetal head station and position |
| Group B | Other | Other: Digital examination, Other: Sonography evaluationDigital examination before instrumental delivery to determine fetal head station and position + sonography evaluation of fetal head position |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with singleton cephalic pregnancies at term (≥37 weeks' gestation), who require an instrumental delivery
Key exclusion criteria (5 listed)
- under 18 years of age
- women with contraindications for vacuum delivery
- women with sonography evaluation of fetal head position before randomization
- fetal head station > +3
- discretion of the responsible obstetrician in cases where there is urgency due to suspected fetal compromise("fetal distress")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital examination | Other | Group A, Group B |
| Sonography evaluation | Other | Group B |
Primary outcome
failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries).
Time frame: 2 years
2 secondary outcomes
Incidence of: neonatal trauma (cephalhaematoma, retinal haemorrhage, facial nerve palsy, brachial plexus injury and fractures), low Apgar scores, fetal acidosis or admission to the neonatal unit, shoulder dystocia
Time frame: 2 years
Incidence of: primary postpartum haemorrhage, third and fourth degree perineal tears
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Background: PubMed 21183150Groutz A, Hasson J, Wengier A, Gold R, Skornick-Rapaport A, Lessing JB, Gordon D. Third- and fourth-degree perineal tears: prevalence and risk factors in the third millennium. Am J Obstet Gynecol. 2011 Apr;204(4):347.e1-4. doi: 10.1016/j.ajog.2010.11.019. Epub 2010 Dec 22.
- Background: PubMed 10580069Towner D, Castro MA, Eby-Wilkens E, Gilbert WM. Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med. 1999 Dec 2;341(23):1709-14. doi: 10.1056/NEJM199912023412301.
- Background: PubMed 15746684Dupuis O, Silveira R, Zentner A, Dittmar A, Gaucherand P, Cucherat M, Redarce T, Rudigoz RC. Birth simulator: reliability of transvaginal assessment of fetal head station as defined by the American College of Obstetricians and Gynecologists classification. Am J Obstet Gynecol. 2005 Mar;192(3):868-74. doi: 10.1016/j.ajog.2004.09.028.
- Background: PubMed 12768552Akmal S, Kametas N, Tsoi E, Hargreaves C, Nicolaides KH. Comparison of transvaginal digital examination with intrapartum sonography to determine fetal head position before instrumental delivery. Ultrasound Obstet Gynecol. 2003 May;21(5):437-40. doi: 10.1002/uog.103.
- Background: PubMed 22762840Ramphul M, Kennelly M, Murphy DJ. Establishing the accuracy and acceptability of abdominal ultrasound to define the foetal head position in the second stage of labour: a validation study. Eur J Obstet Gynecol Reprod Biol. 2012 Sep;164(1):35-9. doi: 10.1016/j.ejogrb.2012.06.001. Epub 2012 Jul 2.
- Background: PubMed 18307213Rozenberg P, Porcher R, Salomon LJ, Boirot F, Morin C, Ville Y. Comparison of the learning curves of digital examination and transabdominal sonography for the determination of fetal head position during labor. Ultrasound Obstet Gynecol. 2008 Mar;31(3):332-7. doi: 10.1002/uog.5267.
- Background: PubMed 16098859Zahalka N, Sadan O, Malinger G, Liberati M, Boaz M, Glezerman M, Rotmensch S. Comparison of transvaginal sonography with digital examination and transabdominal sonography for the determination of fetal head position in the second stage of labor. Am J Obstet Gynecol. 2005 Aug;193(2):381-6. doi: 10.1016/j.ajog.2004.12.011.
- Background: PubMed 17585916Wong GY, Mok YM, Wong SF. Transabdominal ultrasound assessment of the fetal head and the accuracy of vacuum cup application. Int J Gynaecol Obstet. 2007 Aug;98(2):120-3. doi: 10.1016/j.ijgo.2007.05.021. Epub 2007 Jun 22.
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.
Tullio Ghi principal investigator
Department of Obstetrics and Gynecology, Sant'Orsola-Malpighi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital examination and Sonography evaluation in people with Vacuum Extraction; Failure, Affecting Fetus or Newborn and Persistent Occiput Posterior Position During Labor, run by University of Bologna at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 3 May 2017. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tullio Ghi, Dr (0516364411, tullio.ghi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure rate of vacuum extraction in each of the two groups of patients included in the study (number of cesarean deliveries). (time frame: 2 years). 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 NCT01991665, which also lists 8 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 3 May 2017.