PregnancyPhase 4NCT00991627
Different Approaches to Maternal Hypotension During Cesarean Section
A Phase 4 study testing Bupivacaine, Morphine and Lactated Ringer's solution in people with Pregnancy and Cesarean Section, run by University of Parma at 1 site in Italy.
Trial summary
The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy, Cesarean Section, Anesthesia,Spinal
- What is being tested?
- Bupivacaine, Morphine and Lactated Ringer's solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2009to Aug 2010
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing spinal anesthesia for elective Cesarean section
- Patients in ASA Physical Status Class I or II
- Informed written consent to participation
- Positive Supine Stress Test
Who cannot join
- Any known fetal pathology
- Indication to general anesthesia
- Known allergy to any of the study drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site
University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
Parma, PR, 43126
About this study
Official title: Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial
The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.
Read the detailed description
The supine hypotensive syndrome of pregnancy is induced by compression of the inferior caval vein by the enlarged uterus. It occurs in approximately 8% of pregnant women at term. More patients may develop an asymptomatic variety of this syndrome in the supine position. The hypotensive effect of spinal anesthesia per se may thus be aggravated in a significant number of term parturients. A preoperative supine stress test (SST) before elective cesarean section under spinal anesthesia has been shown to predict severe systolic hypotension with reasonable accuracy.
Different strategies have been proposed for the management of this complication; they can be divided into pharmacological and non-pharmacological ones.
According to pharmacological strategies, vasoactive drugs are used to treat hypotension induced by sympathetic efferent blockade following spinal anesthesia. To this end, α-agonist ephedrine is commonly considered the best choice because of its minimal impact on the fetoplacental circulation. However, excessive use of ephedrine may be detrimental to neonatal well-being because of its vasoconstrictor effect on fetoplacental circulation.
Non-pharmacological treatments may represent a valuable, safer alternative. According to many authors non-pharmacological treatments aimed at removing the cause of aorta-caval compression syndrome are to be preferred because more appropriate from an etiopathogenetic point of view. The use of a wedge-shaped cushion placed under the right hip is a well-known non-pharmacological strategy which allows the uterine left lateral displacement and, consequently, the removing of the compression from the inferior vena cava.
The aim of the present study is to compare, through the evaluation of neonatal well-being, the efficacy of these approaches to hypotension after spinal anesthesia for elective Caesarean section in parturients affected by aorto-caval compression.
- Conditions
- Pregnancy, Cesarean Section, Anesthesia,Spinal, Hypotension
- Being tested
- Bupivacaine, Morphine, Lactated Ringer's solution, Ephedrine, continuous infusion, Ephedrine, bolus
- Keywords
- Ephedrine, Adrenergic Agents, Central Nervous System Stimulants, Sympathomimetics, Vasoconstrictor Agents, Bupivacaine, Anesthetics, Local, Atropine, Adjuvants, Anesthesia, Anti-Arrhythmia Agents, Bronchodilator Agents, Muscarinic Antagonists, Mydriatics, Parasympatholytics, Morphine, Analgesics, Opioid, Narcotics, Ringer's Lactate, Isotonic Solutions, Hypotension
- Medical subject headings
- Hypotension, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcain, Local Anesthetic
10 mg of a 5 mg/ml hyperbaric solution, intrathecally
MorphineDrug
Also called Intrathecal morphine
200 µg of a 100 µg/ml solution, intrathecally
Lactated Ringer's solutionDrug
25 ml/min intravenously
Ephedrine, continuous infusionDrug
37.5 mg/h intravenously
Ephedrine, bolusDrug
6.25 mg IV bolus prn.
Hypotension defined according to study protocol for each arm.
AtropineDrug
0.1 mg/kg iv bolus prn
Bradycardia defined as 50% drop in heart rate from baseline values.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacological | Active comparator | Patients in this group will receive a basal infusion of ephedrine. Hypotension will be treated for a reduction in systolic blood pressure 20% below baseline values. Receives: Drug: Bupivacaine; Drug: Morphine; Drug: Lactated Ringer's solution; Drug: Ephedrine, continuous infusion; Drug: Ephedrine, bolus; Drug: Atropine |
| Non-Pharmacological | Experimental | Patients in this group will undergo uterine lateral displacement through the use of a wedge-shaped cushion placed under their right hip. Hypotension will be treated for a reduction in systolic blood pressure 40% below baseline values. Receives: Drug: Bupivacaine; Drug: Morphine; Drug: Lactated Ringer's solution; Drug: Ephedrine, bolus; Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal arterial base excess
Measured: <5 min from birth
Secondary outcomes (10)
Neonatal arterial and venous pH, venous base excess
Measured: <5 min from birth
Apgar score
Measured: 1 and 5 minutes from birth
Maternal serum levels of cardiac troponin (baseline, immediate postsurgery, 6 and 12 hours after surgery)
Measured: Baseline and up to 12 h postoperatively
Incidence of maternal hypotension ( <20% baseline or mean arterial pressure <60 mmHg).
Measured: q5min from anesthesia to end of surgery
Incidence of maternal bradycardia (heart rate <30% of baseline or <60 beats per minute)
Measured: q5min from anesthesia to end of surgery
Peripheral arterial oxygen saturation: incidence of desaturation (SpO2 <92%) and mean values for each arm.
Measured: q5min from anesthesia to end of surgery
Administered atropine
Measured: from anesthesia to end of surgery
Amount of ephedrine administered (mg)
Measured: from anesthesia to end of surgery
Time between induction of anesthesia and skin incision
Time between skin incision and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Parma
- Investigators
- Guido Fanelli, MD, Study chair, Dept. of Anesthesiology and Critical Care Medicine, University of Parma, ItalyAndrea Cornini, MD, Study director, UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di ParmaMichele Zasa, MD, Principal investigator, Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991627
- Sponsor's protocol ID
- ANEST-OST-02
- Status last verified
- Aug 2010
- First submitted
- 7 Oct 2009
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994 May;83(5 Pt 1):774-88.
PubMed 8164943Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. doi: 10.1002/14651858.CD002251.pub2.
PubMed 17054153Kinsella SM, Norris MC. Advance prediction of hypotension at cesarean delivery under spinal anesthesia. Int J Obstet Anesth. 1996 Jan;5(1):3-7. doi: 10.1016/s0959-289x(96)80067-7.
PubMed 15321375Helwig JT, Parer JT, Kilpatrick SJ, Laros RK Jr. Umbilical cord blood acid-base state: what is normal? Am J Obstet Gynecol. 1996 Jun;174(6):1807-12; discussion 1812-4. doi: 10.1016/s0002-9378(96)70214-4.
PubMed 8678144
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00991627
- Acronym / sponsor ID
- ANEST-OST-02
- Conditions
- Pregnancy, Cesarean Section, Anesthesia,Spinal, Hypotension
- Keywords
- Ephedrine, Adrenergic Agents, Central Nervous System Stimulants, Sympathomimetics, Vasoconstrictor Agents, Bupivacaine, Anesthetics, Local, Atropine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Parma
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 Oct 2009 (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 aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.
Detailed description
The supine hypotensive syndrome of pregnancy is induced by compression of the inferior caval vein by the enlarged uterus. It occurs in approximately 8% of pregnant women at term. More patients may develop an asymptomatic variety of this syndrome in the supine position. The hypotensive effect of spinal anesthesia per se may thus be aggravated in a significant number of term parturients. A preoperative supine stress test (SST) before elective cesarean section under spinal anesthesia has been shown to predict severe systolic hypotension with reasonable accuracy.
Different strategies have been proposed for the management of this complication; they can be divided into pharmacological and non-pharmacological ones.
According to pharmacological strategies, vasoactive drugs are used to treat hypotension induced by sympathetic efferent blockade following spinal anesthesia. To this end, α-agonist ephedrine is commonly considered the best choice because of its minimal impact on the fetoplacental circulation. However, excessive use of ephedrine may be detrimental to neonatal well-being because of its vasoconstrictor effect on fetoplacental circulation.
Non-pharmacological treatments may represent a valuable, safer alternative. According to many authors non-pharmacological treatments aimed at removing the cause of aorta-caval compression syndrome are to be preferred because more appropriate from an etiopathogenetic point of view. The use of a wedge-shaped cushion placed under the right hip is a well-known non-pharmacological strategy which allows the uterine left lateral displacement and, consequently, the removing of the compression from the inferior vena cava.
The aim of the present study is to compare, through the evaluation of neonatal well-being, the efficacy of these approaches to hypotension after spinal anesthesia for elective Caesarean section in parturients affected by aorto-caval compression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacological | Active comparator | Drug: Bupivacaine, Drug: Morphine, Drug: Lactated Ringer's solution, Drug: Ephedrine, continuous infusion, Drug: Ephedrine, bolus, Drug: AtropinePatients in this group will receive a basal infusion of ephedrine. Hypotension will be treated for a reduction in systolic blood pressure 20% below baseline values. |
| Non-Pharmacological | Experimental | Drug: Bupivacaine, Drug: Morphine, Drug: Lactated Ringer's solution, Drug: Ephedrine, bolus, Drug: AtropinePatients in this group will undergo uterine lateral displacement through the use of a wedge-shaped cushion placed under their right hip. Hypotension will be treated for a reduction in systolic blood pressure 40% below baseline values. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients undergoing spinal anesthesia for elective Cesarean section
- Patients in ASA Physical Status Class I or II
- Informed written consent to participation
- Positive Supine Stress Test
Key exclusion criteria (3 listed)
- Any known fetal pathology
- Indication to general anesthesia
- Known allergy to any of the study drugs
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 |
|---|---|---|
| BupivacaineAlso: Marcain, Local Anesthetic10 mg of a 5 mg/ml hyperbaric solution, intrathecally | Drug | Non-Pharmacological, Pharmacological |
| MorphineAlso: Intrathecal morphine200 µg of a 100 µg/ml solution, intrathecally | Drug | Non-Pharmacological, Pharmacological |
| Lactated Ringer's solution25 ml/min intravenously | Drug | Non-Pharmacological, Pharmacological |
| Ephedrine, continuous infusion37.5 mg/h intravenously | Drug | Pharmacological |
| Ephedrine, bolus6.25 mg IV bolus prn. Hypotension defined according to study protocol for each arm. | Drug | Non-Pharmacological, Pharmacological |
| Atropine0.1 mg/kg iv bolus prn Bradycardia defined as 50% drop in heart rate from baseline values. | Drug | Non-Pharmacological, Pharmacological |
Primary outcome
Neonatal arterial base excess
Time frame: <5 min from birth
10 secondary outcomes
Neonatal arterial and venous pH, venous base excess
Time frame: <5 min from birth
Apgar score
Time frame: 1 and 5 minutes from birth
Maternal serum levels of cardiac troponin (baseline, immediate postsurgery, 6 and 12 hours after surgery)
Time frame: Baseline and up to 12 h postoperatively
Incidence of maternal hypotension ( <20% baseline or mean arterial pressure <60 mmHg).
Time frame: q5min from anesthesia to end of surgery
Incidence of maternal bradycardia (heart rate <30% of baseline or <60 beats per minute)
Time frame: q5min from anesthesia to end of surgery
Peripheral arterial oxygen saturation: incidence of desaturation (SpO2 <92%) and mean values for each arm.
Time frame: q5min from anesthesia to end of surgery
Administered atropine
Time frame: from anesthesia to end of surgery
Amount of ephedrine administered (mg)
Time frame: from anesthesia to end of surgery
Time between induction of anesthesia and skin incision
Time between skin incision and delivery
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 27 Aug 2010.
- Background: PubMed 8164943Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994 May;83(5 Pt 1):774-88.
- Background: PubMed 17054153Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. doi: 10.1002/14651858.CD002251.pub2.
- Background: PubMed 15321375Kinsella SM, Norris MC. Advance prediction of hypotension at cesarean delivery under spinal anesthesia. Int J Obstet Anesth. 1996 Jan;5(1):3-7. doi: 10.1016/s0959-289x(96)80067-7.
- Background: PubMed 8678144Helwig JT, Parer JT, Kilpatrick SJ, Laros RK Jr. Umbilical cord blood acid-base state: what is normal? Am J Obstet Gynecol. 1996 Jun;174(6):1807-12; discussion 1812-4. doi: 10.1016/s0002-9378(96)70214-4.
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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.
Guido Fanelli, MD study chair
Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
Andrea Cornini, MD study director
UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma
Michele Zasa, MD principal investigator
Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
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 Bupivacaine, Morphine and Lactated Ringer's solution in people with Pregnancy and Cesarean Section, run by University of Parma 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 4 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: finished, as of the sponsor's last update on 27 Aug 2010. 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.
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?
Neonatal arterial base excess (time frame: <5 min from birth). 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 NCT00991627, 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 Aug 2010.