Uterine AtonyPhase 4NCT01549223
Oxytocin And Uterotonic Agent Use For Cesarean Delivery
A Phase 4 study testing Oxytocin Infusion and Oxytocin Bolus in people with Uterine Atony and Hypotension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Atony, Hypotension
- What is being tested?
- Oxytocin Infusion and Oxytocin Bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jan 2012
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I or II health status
- Age between 18 and 50 yrs
- Singleton pregnancies in vertex position
- Elective (without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision
Who cannot join
- Conditions that predispose to uterine atony and postpartum hemorrhage
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Controlled Trial of Standardized Versus Conventional Oxytocin and Uterotonic Agent Use for Cesarean Delivery
The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery
The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective cesarean delivery will:
- Reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone.
Secondary outcomes to be evaluated will be:
- Reduce the side effects associated with uterotonic drug use
- Reduce the time to establishment and maintenance of adequate uterine tone
Read the detailed description
The current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague. A stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner. This algorithm should encompass laboring and non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other uterotonic agents.
More specifically, the investigators believe that the following points should be incorporated into a protocol: 1) oxytocin should be used in initial doses of less than 5 IU; 2) oxytocin should not be administered as a rapid IV bolus; 3) an initial rapid infusion of oxytocin should be followed by a maintenance infusion; 4) higher initial and infusion doses of oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin is not producing effective uterine contractions, other uterotonic drugs acting via different pathways should be considered in a standardized way.
- Conditions
- Uterine Atony, Hypotension
- Being tested
- Oxytocin Infusion, Oxytocin Bolus
- Keywords
- Uterine Atony, Hypotension, Cesarean Delivery, Hemorrhage, Phenylephrine, Ephedrine
- Medical subject headings
- Uterine Inertia, Hypotension, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin InfusionDrug
Also called methylergonovine maleate (methergine) 0.2 mg IM, carboprost tromethamine (hemabate) 0.25 mg IM, misoprostol 600 mcg buccally
500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
Oxytocin BolusDrug
Also called methylergonovine maleate (methergine) 0.2 mg IM, carboprost tromethamine (hemabate) 0.25 mg IM, misoprostol 600 mcg buccally
3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | Active comparator | "Standard Care Group" (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion "oxytocin". If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM (intramuscular) or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally. Receives: Drug: Oxytocin Infusion |
| Protocol Group | Active comparator | "Protocol Group" will receive 3 mL syringes marked "study solution-oxytocin" which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked "study solution-9 min", containing methylergonovine maleate (methergine) 0.2mg, will be given IM.
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked "study solution-12 min", containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally. Receives: Drug: Oxytocin Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.
Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.
Measured: Up to 15 min from time of infant delivery
Secondary outcomes (1)
Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use
Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.
Measured: Up to 15 min from time of infant delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionJan 2012
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 Uterine AtonyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Ching Tsen, Brigham and Women's Hospital
- Investigators
- Lawrence C Tsen, MD, Principal investigator, Brigham and Women's Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549223
- Sponsor's protocol ID
- 2010-P-002284
- Status last verified
- Jun 2017
- First submitted
- 3 Mar 2012
- Last updated
- 29 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Standardized Versus Conventional Oxytocin and Uterotonic Agent Use for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT01549223
- Acronym / sponsor ID
- 2010-P-002284
- Conditions
- Uterine Atony, Hypotension
- Keywords
- Uterine Atony, Hypotension, Cesarean Delivery, Hemorrhage, Phenylephrine, Ephedrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Posted 29 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery
The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective cesarean delivery will:
- Reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone.
Secondary outcomes to be evaluated will be:
- Reduce the side effects associated with uterotonic drug use
- Reduce the time to establishment and maintenance of adequate uterine tone
Detailed description
The current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague. A stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner. This algorithm should encompass laboring and non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other uterotonic agents.
More specifically, the investigators believe that the following points should be incorporated into a protocol: 1) oxytocin should be used in initial doses of less than 5 IU; 2) oxytocin should not be administered as a rapid IV bolus; 3) an initial rapid infusion of oxytocin should be followed by a maintenance infusion; 4) higher initial and infusion doses of oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin is not producing effective uterine contractions, other uterotonic drugs acting via different pathways should be considered in a standardized way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | Active comparator | Drug: Oxytocin Infusion"Standard Care Group" (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion "oxytocin". If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM (intramuscular) or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded. If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally. |
| Protocol Group | Active comparator | Drug: Oxytocin Bolus"Protocol Group" will receive 3 mL syringes marked "study solution-oxytocin" which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale). If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked "study solution-9 min", containing methylergonovine maleate (methergine) 0.2mg, will be given IM. If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked "study solution-12 min", containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM. If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) I or II health status
- Age between 18 and 50 yrs
- Singleton pregnancies in vertex position
- Elective (without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision
Key exclusion criteria (1 listed)
- Conditions that predispose to uterine atony and postpartum hemorrhage
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 |
|---|---|---|
| Oxytocin InfusionAlso: methylergonovine maleate (methergine) 0.2 mg IM, carboprost tromethamine (hemabate) 0.25 mg IM, misoprostol 600 mcg buccally500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. | Drug | Standard Care Group |
| Oxytocin BolusAlso: methylergonovine maleate (methergine) 0.2 mg IM, carboprost tromethamine (hemabate) 0.25 mg IM, misoprostol 600 mcg buccally3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale). | Drug | Protocol Group |
Primary outcome
1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.
Time frame: Up to 15 min from time of infant delivery
Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.
1 secondary outcome
Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use
Time frame: Up to 15 min from time of infant delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lawrence C Tsen, MD principal investigator
Brigham and Women's Hospital/Harvard Medical School
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 Oxytocin Infusion and Oxytocin Bolus in people with Uterine Atony and Hypotension, run by Brigham and Women's Hospital 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 4 inclusion and 1 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 29 Jun 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 29 Jun 2017). 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?
1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone. (time frame: Up to 15 min from time of infant delivery). 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 29 Jun 2017.