Complications; Cesarean SectionPhase 4OBDUCNCT01509521
The Oxygenation of the Brain During Caesarean Section
A Phase 4 study testing Ephedrine and Phenylephrine in people with Complications; Cesarean Section, run by Naestved Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate. 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
- Complications; Cesarean Section
- What is being tested?
- Ephedrine and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Aug 2012
- Phase
- Phase 4
- 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
- Healthy pregnant women
- Over 18 years old
- ASA 1-2
- Undergoing elective caesarean section
- Height over 160 cm or under 180 cm
Who cannot join
- Allergic reactions to ephedrine or phenylephrine
- High blood levels of bilirubin
- HELPP syndrome
- Preeclampsia (pregnancy-induced hypertension)
- Non singleton pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine
The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.
- Conditions
- Complications; Cesarean Section
- Being tested
- Ephedrine, Phenylephrine
- Keywords
- Spectroscopy, Near-Infrared, Fetal heartrate, Ephedrine, Phenylephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
Also called Efedrin, Ephedrine hydrochloride
An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.
PhenylephrineDrug
Also called Phenylephrine Hydrochloride, Metaoxedrin
An infusion of maximum 4 mg/hour for maximum 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine | Active comparator | Not described Receives: Drug: Ephedrine |
| Phenylephrine | Active comparator | Not described Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frontal lobe cerebral oxygenation
Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery.
Measured: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Foetal heartrate
From before induction of spinal anaesthesia to 15 min after delivery
Measured: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Secondary outcomes (3)
Mean arterial pressure
The mean arterial pressure is measures from before induction of spinal anaesthesia to end of surgery.
Measured: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Cardiac output
The cardiac output is measures from before induction of spinal anaesthesia to end of surgery.
Measured: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Umbilical cord pH and Base excess
The umbilical cord blood analysis for evaluation of the newborn's acid-base status is taken immediately after delivery. It is the most objective way of assessing the fetal metabolic condition at birth.
Measured: Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complications; Cesarean SectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Visti Foss, Naestved Hospital
- Investigators
- Visti Foss, Principal investigator, Naestved Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509521
- Sponsor's protocol ID
- 2011-006103-35
- Other IDs
- SJ-271
- Acronym
- OBDUC
- Status last verified
- Aug 2012
- First submitted
- 8 Jan 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.
PubMed 32619039Foss VT, Christensen R, Rokamp KZ, Nissen P, Secher NH, Nielsen HB. Effect of phenylephrine vs. ephedrine on frontal lobe oxygenation during caesarean section with spinal anesthesia: an open label randomized controlled trial. Front Physiol. 2014 Mar 3;5:81. doi: 10.3389/fphys.2014.00081. eCollection 2014.
PubMed 24624090
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oxygenation of the Brain During Caesarean Section. A Comparison of Ephedrine Versus Phenylephrine
- ClinicalTrials.gov ID
- NCT01509521
- Acronym / sponsor ID
- OBDUC / 2011-006103-35
- Conditions
- Complications; Cesarean Section
- Keywords
- Spectroscopy, Near-Infrared, Fetal heartrate, Ephedrine, Phenylephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Jan 2012 (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.
The purpose of this study is to determine the impact of phenylephrine versus ephedrine on organ perfusion, in women undergoing caesarean section receiving spinal anaesthesia. The organ perfusion is estimated by measuring the maternal cerebral oxygenation by NIRS(Near-infrared spectroscopy)and the foetal heartrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ephedrine | Active comparator | Drug: Ephedrine |
| Phenylephrine | Active comparator | Drug: Phenylephrine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy pregnant women
- Over 18 years old
- ASA 1-2
- Undergoing elective caesarean section
- Height over 160 cm or under 180 cm
Key exclusion criteria (5 listed)
- Allergic reactions to ephedrine or phenylephrine
- High blood levels of bilirubin
- HELPP syndrome
- Preeclampsia (pregnancy-induced hypertension)
- Non singleton pregnancies
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 |
|---|---|---|
| EphedrineAlso: Efedrin, Ephedrine hydrochlorideAn infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope. | Drug | Ephedrine |
| PhenylephrineAlso: Phenylephrine Hydrochloride, MetaoxedrinAn infusion of maximum 4 mg/hour for maximum 60 minutes. | Drug | Phenylephrine |
Primary outcome
Frontal lobe cerebral oxygenation
Time frame: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Determine the frontal lobe cerebral oxygantion by Near-Infrared Spectroscopy (NIRS),from before induction of spinal anaesthesia to end of surgery.
Foetal heartrate
Time frame: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
From before induction of spinal anaesthesia to 15 min after delivery
3 secondary outcomes
Mean arterial pressure
Time frame: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Cardiac output
Time frame: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour
Umbilical cord pH and Base excess
Time frame: Blood analysis taken immediately after the the clamping of the umbilical cord, an average of 20 minutes.
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 7 Aug 2012.
- Derived from this study: PubMed 32619039Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.
- Derived from this study: PubMed 24624090Foss VT, Christensen R, Rokamp KZ, Nissen P, Secher NH, Nielsen HB. Effect of phenylephrine vs. ephedrine on frontal lobe oxygenation during caesarean section with spinal anesthesia: an open label randomized controlled trial. Front Physiol. 2014 Mar 3;5:81. doi: 10.3389/fphys.2014.00081. eCollection 2014.
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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.
Visti Foss principal investigator
Naestved Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ephedrine and Phenylephrine in people with Complications; Cesarean Section, run by Naestved Hospital at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 7 Aug 2012. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frontal lobe cerebral oxygenation (time frame: Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour). The study lists 2 primary outcomes in all. 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 NCT01509521, which also lists 2 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 7 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.