Uterine AtonyPhase 4NCT00790062
Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
A Phase 4 study testing Oxytocin in people with Uterine Atony and Postpartum Hemorrhage, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Atony, Postpartum Hemorrhage
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,798 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jun 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- > 24 weeks, viable pregnancy, singleton or twins
Who cannot join
- No consent
- Contraindication to oxytocin
- Antepartum fetal demise
- Intrapartum use of concentrated oxytocin
- Planned cesarean
- DIC or coagulopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery
This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not known.
Read the detailed description
Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member DSMB in January of 2010 and their recommendations were implemented.
- Conditions
- Uterine Atony, Postpartum Hemorrhage
- Being tested
- Oxytocin
- Keywords
- Uterine atony, Postpartum hemorrhage, clinical trial, Prophylactic oxytocin
- Medical subject headings
- Uterine Inertia, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
See arms
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin 10 units/500cc | Active comparator | 1 dose only for prophylaxis given over 1 hour Receives: Drug: Oxytocin |
| Oxytocin 40 units/500cc | Experimental | One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010. Receives: Drug: Oxytocin |
| Oxytocin 80U/500cc | Experimental | 1 dose only given over 1 hour Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment
the number of subjects with any treatment of uterineatony or hemorrhage.
Measured: baseline to discharge (2 - 3 days)
Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage
In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.
Measured: Initial hospital discharge (2-3 days)
Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors
The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.
Measured: baseline to discharge (2-3 days)
Secondary outcomes (5)
Change in Pre- to Post-delivery Hematocrit (%)
change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)
Measured: During delivery hospitalization: Admission hematocrit - post-delivery hematocrit
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
the number of individuals with each of the component treatments or individual outcomes in the primary composite.
Measured: prior to discharge
Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)
the number of individuals with a clinically estimated postpartum blood loss of 500cc or more
Measured: Initial hospital discharge (2-3 days)
Number of Subjects With Hospital Stays Greater Than 4 Days
Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge
Measured: Initial hospital discharge (2 days or more)
Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus
number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)
Measured: Initial hospital discharge (2-3 days or more)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2010
- Study completionJun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine AtonyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,798 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Alan Tita, University of Alabama at Birmingham
- Investigators
- Alan T Tita, MD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790062
- Sponsor's protocol ID
- F070910007
- Other IDs
- 5K12HD001258-09
- Status last verified
- Mar 2016
- First submitted
- 12 Nov 2008
- Last updated
- 8 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.1097/AOG.0b013e318242da74.
PubMed 22227638
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of 3 Different Dose Regimens of Oxytocin in Preventing Uterine Atony and Postpartum Hemorrhage During Vaginal Delivery
- ClinicalTrials.gov ID
- NCT00790062
- Acronym / sponsor ID
- F070910007
- Conditions
- Uterine Atony, Postpartum Hemorrhage
- Keywords
- Uterine atony, Postpartum hemorrhage, clinical trial, Prophylactic oxytocin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,798 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 30 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not known.
Detailed description
Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member DSMB in January of 2010 and their recommendations were implemented.
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 |
|---|---|---|
| Oxytocin 10 units/500cc | Active comparator | Drug: Oxytocin1 dose only for prophylaxis given over 1 hour |
| Oxytocin 40 units/500cc | Experimental | Drug: OxytocinOne dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010. |
| Oxytocin 80U/500cc | Experimental | Drug: Oxytocin1 dose only given over 1 hour |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- > 24 weeks, viable pregnancy, singleton or twins
Key exclusion criteria (6 listed)
- No consent
- Contraindication to oxytocin
- Antepartum fetal demise
- Intrapartum use of concentrated oxytocin
- Planned cesarean
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 |
|---|---|---|
| OxytocinAlso: PitocinSee arms | Drug | Oxytocin 10 units/500cc, Oxytocin 40 units/500cc, Oxytocin 80U/500cc |
Primary outcome
Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment
Time frame: baseline to discharge (2 - 3 days)
the number of subjects with any treatment of uterineatony or hemorrhage.
Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage
Time frame: Initial hospital discharge (2-3 days)
In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.
Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors
Time frame: baseline to discharge (2-3 days)
The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.
5 secondary outcomes
Change in Pre- to Post-delivery Hematocrit (%)
Time frame: During delivery hospitalization: Admission hematocrit - post-delivery hematocrit
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
Time frame: prior to discharge
Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)
Time frame: Initial hospital discharge (2-3 days)
Number of Subjects With Hospital Stays Greater Than 4 Days
Time frame: Initial hospital discharge (2 days or more)
Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus
Time frame: Initial hospital discharge (2-3 days or more)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22227638Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.1097/AOG.0b013e318242da74.
- PUBMED Abstract of ResultsLink provided by the sponsor.
Related trials for Uterine Atony
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Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingPhase 4
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 2
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
Blood Loss, Surgical, Blood Loss, Postoperative
Recruiting
Administration Of Calcium Gluconate for The Reduction of Blood Loss During Vaginal Delivery
Postpartum Hemorrhage
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.
Alan T Tita, MD, PhD principal investigator
University of Alabama at Birmingham
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 in people with Uterine Atony and Postpartum Hemorrhage, run by University of Alabama at Birmingham 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 1 inclusion and 6 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 8 Apr 2016. 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 30 Jan 2014). 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?
Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment (time frame: baseline to discharge (2 - 3 days)). The study lists 3 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 NCT00790062, 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 8 Apr 2016.