Cesarean DeliveryNCT01216410
Prevention of Intraoperative Nausea and Vomiting During Cesarean Section
A study testing Metoclopramide, Phenylephrine infusion and Combination Group in people with Cesarean Delivery, run by Duke University at 1 site in United States.
Trial summary
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- Metoclopramide, Phenylephrine infusion and Combination Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Apr 2011
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
- Scheduled or unscheduled cesarean delivery under spinal anesthesia
- Height: 5 feet-5 feet 11 in.
Who cannot join
- Laboring women needing an emergency cesarean delivery
- Subjects less than 18 years of age
- Receipt of a drug with antiemetic properties in the 24 hours prior to cesarean section
- Allergy to ondansetron, or metoclopramide
- Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
- Severe Cardiac disease in pregnancy with marked functional limitations
Show all 10Show fewer
- Diabetes type I
- Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
- Morbid obesity (body mass index (BMI)>45)
- Inclusion in another anesthetic study involving drug administration
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: The Effect of Adding Metoclopramide and Ondansetron to a Prophylactic Phenylephrine Infusion for the Management of Nausea and Vomiting Associated With Spinal Anesthesia for Cesarean Section
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
- Conditions
- Cesarean Delivery
- Being tested
- Metoclopramide, Phenylephrine infusion, Combination Group
- Keywords
- Nausea, Vomiting
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion
Phenylephrine infusionDrug
Prophylactic phenylephrine infusion after spinal and placebo antiemetics
Combination GroupDrug
Also called Metoclopramide and ondansetron
Metoclopramide and ondansetron prophylaxis with phenylephrine infusion
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Active comparator | Prophylaxis with metoclopramide and phenylephrine infusion. Receives: Drug: Metoclopramide |
| Phenylephrine infusion | Placebo comparator | Prophylactic phenylephrine infusion and placebo antiemetics Receives: Drug: Phenylephrine infusion |
| Combination Group | Active comparator | Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion Receives: Drug: Combination Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Nausea and Vomiting
Comparison of intraoperative nausea and vomiting between the 3 groups.
Measured: Intraoperatively
Secondary outcomes (4)
Postoperative Nausea and Vomiting (PONV)
Measured: 0-2h, 2-6h, 6-24h
Pruritus
Measured: 0-24 hrs
Satisfaction
1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.
Measured: 24 h
Maternal Hemodynamics
The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startDec 2008
- Primary completionApr 2011
- Study completionApr 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Duke 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- IWK Health Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216410
- Sponsor's protocol ID
- Pro00012142
- Other IDs
- Duke-12142
- Status last verified
- Jul 2014
- First submitted
- 6 Oct 2010
- Last updated
- 6 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Habib AS, George RB, McKeen DM, White WD, Ituk US, Megalla SA, Allen TK. Antiemetics added to phenylephrine infusion during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):615-623. doi: 10.1097/AOG.0b013e3182839fee.
PubMed 23635626
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Metoclopramide and Ondansetron to a Prophylactic Phenylephrine Infusion for the Management of Nausea and Vomiting Associated With Spinal Anesthesia for Cesarean Section
- ClinicalTrials.gov ID
- NCT01216410
- Acronym / sponsor ID
- Pro00012142
- Conditions
- Cesarean Delivery
- Keywords
- Nausea, Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- IWK Health Centre
- Study start
- Dec 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Posted 25 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Active comparator | Drug: MetoclopramideProphylaxis with metoclopramide and phenylephrine infusion. |
| Phenylephrine infusion | Placebo comparator | Drug: Phenylephrine infusionProphylactic phenylephrine infusion and placebo antiemetics |
| Combination Group | Active comparator | Drug: Combination GroupMetoclopramide and Ondansetron prophylaxis with phenylephrine infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
- Scheduled or unscheduled cesarean delivery under spinal anesthesia
- Height: 5 feet-5 feet 11 in.
Key exclusion criteria (10 listed)
- Laboring women needing an emergency cesarean delivery
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 |
|---|---|---|
| MetoclopramideProphylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion | Drug | Metoclopramide |
| Phenylephrine infusionProphylactic phenylephrine infusion after spinal and placebo antiemetics | Drug | Phenylephrine infusion |
| Combination GroupAlso: Metoclopramide and ondansetronMetoclopramide and ondansetron prophylaxis with phenylephrine infusion | Drug | Combination Group |
Primary outcome
Intraoperative Nausea and Vomiting
Time frame: Intraoperatively
Comparison of intraoperative nausea and vomiting between the 3 groups.
4 secondary outcomes
Postoperative Nausea and Vomiting (PONV)
Time frame: 0-2h, 2-6h, 6-24h
Pruritus
Time frame: 0-24 hrs
Satisfaction
Time frame: 24 h
Maternal Hemodynamics
Time frame: Intraoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23635626Habib AS, George RB, McKeen DM, White WD, Ituk US, Megalla SA, Allen TK. Antiemetics added to phenylephrine infusion during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):615-623. doi: 10.1097/AOG.0b013e3182839fee.
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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 study testing Metoclopramide, Phenylephrine infusion and Combination Group in people with Cesarean Delivery, run by Duke 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 3 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 6 Aug 2014. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Mar 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?
Intraoperative Nausea and Vomiting (time frame: Intraoperatively). 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 NCT01216410, which also lists 1 linked publication.
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 6 Aug 2014.