Breech Presentation; Before LaborNCT03797833
Spinal Anesthesia for External Cephalic Version
A study testing Spinal Anaesthesia in people with Breech Presentation; Before Labor, run by Region Skane at 2 sites in Sweden.
Trial summary
This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breech Presentation; Before Labor
- What is being tested?
- Spinal Anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSweden
- Study dates
- 7 Jan 2019to 30 Jun 2030
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant nulliparous women.
- Breech presentation of fetus, eligible for external version.
Who cannot join
- Unwilling to participate.
- Unable to understand written and oral Swedish in the absence of interpreter.
- Contraindications to spinal anaesthesia.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Spinal Anesthesia for External Cephalic Version in Nulliparous Women, A Controlled Randomized Study
This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position.
Read the detailed description
Fetuses in breech position are almost always delivered by Caesarian section (CS). If the fetus is in breech position by the end of pregnancy, attempts for external cephalic version (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in multiparous women. There are studies showing a higher rate of successful ECV's if the mother received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with SA. These studies, however, did not take parity into account.
The primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women.
The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV.
- Conditions
- Breech Presentation; Before Labor
- Being tested
- Spinal Anaesthesia
- Keywords
- breech presentation, external version, spinal anaesthesia
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnaesthesiaProcedure or surgery
Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | No intervention | ECV according to standard practice. |
| Spinal anaesthesia | Active comparator | ECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg) Receives: Procedure: Spinal Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
External version success rate
Rate of successful version as assessed by gynaecologist after maximum three attempts.
Measured: 1 hour
Secondary outcomes (3)
Overall maternal satisfaction post external version attempt
Evaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts.
Measured: 1 hour
Overall maternal satisfaction post partum
Evaluation of overall participant satisfaction using an online assessment questionnaire within 3 months from the external version attempts (within 2 months post partum)
Measured: 3 months
Caesarian section rate
The mode of delivery, assessed from the medical charts after delivery.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start7 Jan 2019
- Primary completion31 Jan 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Why it stopped: Slow inclusion rate. Central contact person quit for another job.
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 Breech Presentation; Before LaborStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Herbst, MD PhD, Principal investigator, Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797833
- Sponsor's protocol ID
- 2018/634
- Status last verified
- Oct 2022
- First submitted
- 7 Jan 2019
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khaw KS, Lee SW, Ngan Kee WD, Law LW, Lau TK, Ng FF, Leung TY. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation. Br J Anaesth. 2015 Jun;114(6):944-50. doi: 10.1093/bja/aev107. Epub 2015 May 10.
PubMed 25962611Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27.
PubMed 27131581Cluver C, Gyte GM, Sinclair M, Dowswell T, Hofmeyr GJ. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version. Cochrane Database Syst Rev. 2015 Feb 9;2015(2):CD000184. doi: 10.1002/14651858.CD000184.pub4.
PubMed 25674710Chalifoux LA, Bauchat JR, Higgins N, Toledo P, Peralta FM, Farrer J, Gerber SE, McCarthy RJ, Sullivan JT. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial. Anesthesiology. 2017 Oct;127(4):625-632. doi: 10.1097/ALN.0000000000001796.
PubMed 28723831
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia for External Cephalic Version in Nulliparous Women, A Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT03797833
- Acronym / sponsor ID
- 2018/634
- Conditions
- Breech Presentation; Before Labor
- Keywords
- breech presentation, external version, spinal anaesthesia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Slow inclusion rate. Central contact person quit for another job.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 9 Jan 2019 (actual)
- 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.
This study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position.
Detailed description
Fetuses in breech position are almost always delivered by Caesarian section (CS). If the fetus is in breech position by the end of pregnancy, attempts for external cephalic version (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in multiparous women. There are studies showing a higher rate of successful ECV's if the mother received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with SA. These studies, however, did not take parity into account.
The primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women.
The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –ECV according to standard practice. |
| Spinal anaesthesia | Active comparator | Procedure: Spinal AnaesthesiaECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant nulliparous women.
- Breech presentation of fetus, eligible for external version.
Key exclusion criteria (3 listed)
- Unwilling to participate.
- Unable to understand written and oral Swedish in the absence of interpreter.
- Contraindications to spinal anaesthesia.
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 |
|---|---|---|
| Spinal AnaesthesiaSpinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg | Procedure or surgery | Spinal anaesthesia |
Primary outcome
External version success rate
Time frame: 1 hour
Rate of successful version as assessed by gynaecologist after maximum three attempts.
3 secondary outcomes
Overall maternal satisfaction post external version attempt
Time frame: 1 hour
Overall maternal satisfaction post partum
Time frame: 3 months
Caesarian section rate
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 25962611Khaw KS, Lee SW, Ngan Kee WD, Law LW, Lau TK, Ng FF, Leung TY. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation. Br J Anaesth. 2015 Jun;114(6):944-50. doi: 10.1093/bja/aev107. Epub 2015 May 10.
- Background: PubMed 27131581Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27.
- Background: PubMed 25674710Cluver C, Gyte GM, Sinclair M, Dowswell T, Hofmeyr GJ. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version. Cochrane Database Syst Rev. 2015 Feb 9;2015(2):CD000184. doi: 10.1002/14651858.CD000184.pub4.
- Background: PubMed 28723831Chalifoux LA, Bauchat JR, Higgins N, Toledo P, Peralta FM, Farrer J, Gerber SE, McCarthy RJ, Sullivan JT. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial. Anesthesiology. 2017 Oct;127(4):625-632. doi: 10.1097/ALN.0000000000001796.
- Individual participant dataSharing planned: Undecided
Related trials for Breech Presentation; Before Labor
Recruiting
Mindfulness-based Intervention Prior to External Cephalic Version
Breech Presentation in Pregnancy, External Cephalic Version
Recruiting
An Informative Video Before Planned External Cephalic Version
Breech Presentation
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.
Andreas Herbst, MD PhD principal investigator
Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Anaesthesia in people with Breech Presentation; Before Labor, run by Region Skane at 2 sites in Sweden.
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 2 inclusion and 3 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: paused, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
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?
External version success rate (time frame: 1 hour). 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 NCT03797833, 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 27 Oct 2022.