PregnancyVersionNCT00565383
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position
A study testing Combined spinal-epidural analgesia and Intravenous fentanyl (50mcg) in people with Pregnancy and Breech Presentation, run by Northwestern University at 1 site in United States.
Trial summary
We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or epidural analgesia) during version for breech presentation increases successful fetal rotation and decreases the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pregnancy, Breech Presentation
- What is being tested?
- Combined spinal-epidural analgesia and Intravenous fentanyl (50mcg)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jun 2006
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-55 years of age
- Female
- Pregnant
- Breech Presentation
- Greater than 36 Weeks gestation
- Version Procedure
Who cannot join
- Under 18 or over 55 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position
We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or epidural analgesia) during version for breech presentation increases successful fetal rotation and decreases the incidence of Cesarean delivery for malpresentation.
Read the detailed description
At term 2 to 3% of singleton pregnancies are in breech presentation. Many of these deliveries are managed by cesarean delivery due to higher neonatal morbidity associated with vaginal breech delivery. Cesarean delivery, the safer option for the baby, however, is associated with a higher incidence of maternal complications for both the current and subsequent pregnancies. External cephalic version is a procedure commonly used to attempt to manually rotate the fetus into vertex position. This facilitates vaginal delivery and thus avoids higher maternal and/or neonatal complications.
Obstetricians perform versions after 36 weeks gestational age with a reportable success rate of 30-80%. The most common technique involves external manipulation of the fetal position preceded by pharmacologic uterine relaxation. Pain relief is most commonly provided in the form of intravenous opioids such as fentanyl. A more efficacious form of analgesia is the use of neuraxial opioids and local anesthetics (neuraxial analgesia), a technique commonly used for labor and delivery analgesia.
Although the use of neuraxial analgesia and anesthesia techniques improve maternal pain and satisfaction, there is conflicting evidence if they improve the success rate of version procedures. The American College of Obstetricians and Gynecologists (ACOG) has stated, "Currently there is not enough evidence to make a recommendation favoring or opposing anesthesia during ECV (external cephalic version) attempts."
We propose to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural analgesia on the success rate of external version for breech fetal position and the subsequent incidence of vaginal vs. Cesarean delivery as a secondary outcome.
- Conditions
- Pregnancy, Breech Presentation
- Being tested
- Combined spinal-epidural analgesia, Intravenous fentanyl (50mcg)
- Keywords
- Pregnancy, 37 Weeks Gestation, Breech Presentation, Version Procedure, Pain Control, Neuraxial analgesia
- Medical subject headings
- Breech Presentation, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined spinal-epidural analgesiaProcedure or surgery
Combined spinal-epidural
Intravenous fentanyl (50mcg)Procedure or surgery
Intravenous fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Intravenous fentanyl analgesia | Active comparator | Intravenous fentanyl (50 mcg) analgesia Receives: Procedure: Intravenous fentanyl (50mcg) |
| Combined spinal-epidural analgesia | Experimental | Combined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration Receives: Procedure: Combined spinal-epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does combined spinal-epidural analgesia improve the success rate of external cephalic version?
Measured: Time between analgesia intervention for the version procedure and delivery
Secondary outcomes (3)
Mode of delivery
Measured: At delivery
Maternal satisfaction
Measured: Between analgesic intervention and the completion of the version procedure
Maternal Pain
Measured: Between analgesic intervention and termination of the version procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startAug 2002
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Sullivan, Northwestern University
- Investigators
- John T Sullivan, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565383
- Sponsor's protocol ID
- 0897-002
- Other IDs
- Sullivan 002
- Acronym
- Version
- Status last verified
- Jun 2013
- First submitted
- 29 Nov 2007
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fortunato SJ, Mercer LJ, Guzick DS. External cephalic version with tocolysis: factors associated with success. Obstet Gynecol. 1988 Jul;72(1):59-62.
PubMed 3288930Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12.
PubMed 8336883Carlan SJ, Dent JM, Huckaby T, Whittington EC, Shaefer D. The effect of epidural anesthesia on safety and success of external cephalic version at term. Anesth Analg. 1994 Sep;79(3):525-8. doi: 10.1213/00000539-199409000-00021.
PubMed 8067558Birnbach DJ, Matut J, Stein DJ, Campagnuolo J, Drimbarean C, Grunebaum A, Kuroda MM, Thys DM. The effect of intrathecal analgesia on the success of external cephalic version. Anesth Analg. 2001 Aug;93(2):410-3, 4th contents page. doi: 10.1097/00000539-200108000-00035.
PubMed 11473871
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version for Breech Position
- ClinicalTrials.gov ID
- NCT00565383
- Acronym / sponsor ID
- Version / 0897-002
- Conditions
- Pregnancy, Breech Presentation
- Keywords
- Pregnancy, 37 Weeks Gestation, Breech Presentation, Version Procedure, Pain Control, Neuraxial analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 30 Nov 2007 (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.
We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or epidural analgesia) during version for breech presentation increases successful fetal rotation and decreases the incidence of Cesarean delivery for malpresentation.
Detailed description
At term 2 to 3% of singleton pregnancies are in breech presentation. Many of these deliveries are managed by cesarean delivery due to higher neonatal morbidity associated with vaginal breech delivery. Cesarean delivery, the safer option for the baby, however, is associated with a higher incidence of maternal complications for both the current and subsequent pregnancies. External cephalic version is a procedure commonly used to attempt to manually rotate the fetus into vertex position. This facilitates vaginal delivery and thus avoids higher maternal and/or neonatal complications.
Obstetricians perform versions after 36 weeks gestational age with a reportable success rate of 30-80%. The most common technique involves external manipulation of the fetal position preceded by pharmacologic uterine relaxation. Pain relief is most commonly provided in the form of intravenous opioids such as fentanyl. A more efficacious form of analgesia is the use of neuraxial opioids and local anesthetics (neuraxial analgesia), a technique commonly used for labor and delivery analgesia.
Although the use of neuraxial analgesia and anesthesia techniques improve maternal pain and satisfaction, there is conflicting evidence if they improve the success rate of version procedures. The American College of Obstetricians and Gynecologists (ACOG) has stated, "Currently there is not enough evidence to make a recommendation favoring or opposing anesthesia during ECV (external cephalic version) attempts."
We propose to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural analgesia on the success rate of external version for breech fetal position and the subsequent incidence of vaginal vs. Cesarean delivery as a secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous fentanyl analgesia | Active comparator | Procedure: Intravenous fentanyl (50mcg)Intravenous fentanyl (50 mcg) analgesia |
| Combined spinal-epidural analgesia | Experimental | Procedure: Combined spinal-epidural analgesiaCombined spinal-epidural analgesia (intrathecal fentanyl 2.5 mg plus bupivacaine 2.5 mg) single administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-55 years of age
- Female
- Pregnant
- Breech Presentation
- Greater than 36 Weeks gestation
Key exclusion criteria (1 listed)
- Under 18 or over 55 years of age
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 |
|---|---|---|
| Combined spinal-epidural analgesiaCombined spinal-epidural | Procedure or surgery | Combined spinal-epidural analgesia |
| Intravenous fentanyl (50mcg)Intravenous fentanyl | Procedure or surgery | Intravenous fentanyl analgesia |
Primary outcome
Does combined spinal-epidural analgesia improve the success rate of external cephalic version?
Time frame: Time between analgesia intervention for the version procedure and delivery
3 secondary outcomes
Mode of delivery
Time frame: At delivery
Maternal satisfaction
Time frame: Between analgesic intervention and the completion of the version procedure
Maternal Pain
Time frame: Between analgesic intervention and termination of the version procedure
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 13 Jun 2013.
- Background: PubMed 3288930Fortunato SJ, Mercer LJ, Guzick DS. External cephalic version with tocolysis: factors associated with success. Obstet Gynecol. 1988 Jul;72(1):59-62.
- Background: PubMed 8336883Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12.
- Background: PubMed 8067558Carlan SJ, Dent JM, Huckaby T, Whittington EC, Shaefer D. The effect of epidural anesthesia on safety and success of external cephalic version at term. Anesth Analg. 1994 Sep;79(3):525-8. doi: 10.1213/00000539-199409000-00021.
- Background: PubMed 11473871Birnbach DJ, Matut J, Stein DJ, Campagnuolo J, Drimbarean C, Grunebaum A, Kuroda MM, Thys DM. The effect of intrathecal analgesia on the success of external cephalic version. Anesth Analg. 2001 Aug;93(2):410-3, 4th contents page. doi: 10.1097/00000539-200108000-00035.
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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.
John T Sullivan, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined spinal-epidural analgesia and Intravenous fentanyl (50mcg) in people with Pregnancy and Breech Presentation, run by Northwestern University at 1 site in United States.
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 6 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 13 Jun 2013. 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 United States. 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?
Does combined spinal-epidural analgesia improve the success rate of external cephalic version? (time frame: Time between analgesia intervention for the version procedure and 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 NCT00565383, which also lists 4 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 13 Jun 2013.