HypotensionPhase 4NCT00846651
Spinal Anesthesia Induced Hypotension During Cesarean Section
A Phase 4 study testing Colloid administration, Crystalloid administration and phenylephrine infusion in people with Hypotension, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- Colloid administration, Crystalloid administration and phenylephrine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I and II
- Elective cesarean section
- Weight 50-120 kg, Height 150-180 cm
- Normal singleton pregnancy
- Beyond 36 weeks gestation
- No known fetal abnormalities
- Ages 18-35
Who cannot join
- Contraindications to spinal anesthesia
- Multiple gestation, placenta previa, accreta
- Pregnancy induced hypertension or preeclampsia
- Diabetes mellitus, cardiovascular diseases
- Coagulopathy
- Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction
Show all 10Show fewer
- Baseline HR <65
- Failed spinal anesthesia/inadequate sensory block for surgery
- History of abnormal bleeding
- History of adverse reactions to hydroxyethylstarch
Trial locations and contacts
1 site in 1 country.
United States1 site
PennState Hershey Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-induced Hypotension During Cesarean Section
The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.
Read the detailed description
Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.
- Conditions
- Hypotension
- Being tested
- Colloid administration, Crystalloid administration, phenylephrine infusion
- Keywords
- spinal anesthesia, cesarean section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colloid administrationOther
The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.
Crystalloid administrationOther
The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.
phenylephrine infusionDrug
A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
| Study group | Role | What they receive |
|---|---|---|
| colloid, then phenylephrine infusion | Experimental | colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. Receives: Other: Colloid administration; Drug: phenylephrine infusion |
| crystalloid, then phenylephrine infusion | Active comparator | crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. Receives: Other: Crystalloid administration; Drug: phenylephrine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Maternal Hypotension
Measured: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Secondary outcomes (5)
Dosage of Phenylephrine Used
Measured: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Incidence of Maternal Bradycardia
Measured: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Fetal Cord Blood pH
Measured: delivery of the baby
APGAR Scores
The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).
Measured: Apgar scores were assessed at 1 amd 5 min after delivery of the baby
Incidence of Maternal Nausea and Vomiting
Measured: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypotensionStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Vaida, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846651
- Sponsor's protocol ID
- IRB #29595
- Status last verified
- Sep 2017
- First submitted
- 18 Feb 2009
- Last updated
- 16 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-induced Hypotension During Cesarean Section
- ClinicalTrials.gov ID
- NCT00846651
- Acronym / sponsor ID
- IRB #29595
- Conditions
- Hypotension
- Keywords
- spinal anesthesia, cesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 3 Jul 2013
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 compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.
Detailed description
Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colloid, then phenylephrine infusion | Experimental | Other: Colloid administration, Drug: phenylephrine infusioncolloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
| crystalloid, then phenylephrine infusion | Active comparator | Other: Crystalloid administration, Drug: phenylephrine infusioncrystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- American Society of Anesthesiologists (ASA) physical status I and II
- Elective cesarean section
- Weight 50-120 kg, Height 150-180 cm
- Normal singleton pregnancy
- Beyond 36 weeks gestation
Key exclusion criteria (10 listed)
- Contraindications to spinal anesthesia
- Multiple gestation, placenta previa, accreta
- Pregnancy induced hypertension or preeclampsia
- Diabetes mellitus, cardiovascular diseases
- Coagulopathy
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 |
|---|---|---|
| Colloid administrationThe patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section. | Other | colloid, then phenylephrine infusion |
| Crystalloid administrationThe patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section. | Other | crystalloid, then phenylephrine infusion |
| phenylephrine infusionA phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. | Drug | colloid, then phenylephrine infusion, crystalloid, then phenylephrine infusion |
Primary outcome
Incidence of Maternal Hypotension
Time frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
5 secondary outcomes
Dosage of Phenylephrine Used
Time frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Incidence of Maternal Bradycardia
Time frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Fetal Cord Blood pH
Time frame: delivery of the baby
APGAR Scores
Time frame: Apgar scores were assessed at 1 amd 5 min after delivery of the baby
Incidence of Maternal Nausea and Vomiting
Time frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colloid administration, Crystalloid administration and phenylephrine infusion in people with Hypotension, run by Milton S. Hershey Medical Center 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 7 inclusion and 10 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 16 Oct 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 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.
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?
Yes. Results are posted in the registry (first posted 3 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Maternal Hypotension (time frame: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2017.