Post Partum HemorrhagePhase 4NCT01236482
Oxytocin in Cesarean Delivery
A Phase 4 study testing Oxytocin versus oxytocin-ergometrine in people with Post Partum Hemorrhage, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
In this study the investigators hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone. In order to perform this study the investigators perform the following steps: 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Oxytocin versus oxytocin-ergometrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2010to May 2011
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 80 healthy women presenting for elective repeat cesarean delivery under regional anesthesia.
- All women are ASA class 1-2, aged 18 - 45, with body weight 60-100 kg.
Who cannot join
- Obstetric risk factors: Pre-eclampsia, abnormalities of placentation (eg placenta accrete, placenta previa), amnionitis, multiple gestation, preterm delivery (< 37 completed weeks), more than three previous cesarean deliveries, previous history of ante-partum or post-partum hemorrhage.
- Maternal medical risk factors: Chronic hypertension, cardiac disease, intracranial pathology, known allergies to oxytocin or ergometrine, autoimmune disorders, SLE, coagulation defect or anticoagulation therapy, amnionitis.
- Women asking for cord blood donations are not included in this study due to the long elapsed time between delivery and the commencement of oxytocin.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Hebrew University Medical Center
Jerusalem, 93510
Yehuda Ginosar, MBBS, +972-2-6722077, yginosar@netvision.net.il
Yehuda Ginosar, MBBS
About this study
Official title: Comparing Oxytocin and Oxytocin-ergometrine Combinations for Increasing Uterine Tone in Cesarean Delivery: a Pharmacokinetic-pharmacodynamic Study.
In this study the investigators hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone. In order to perform this study the investigators perform the following steps:
- The investigators validate a quantitative measure of uterine tone as our primary endpoint.
- The investigators use this endpoint measure in order to determine equipotential doses of different tocotonic drug regimens, based on the ED50 for each.
- Using equipontial ratios based on the ED50, the investigators compare hemodynamic and other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be measured.
Read the detailed description
Obstetric hemorrhage is associated with severe maternal morbidityש and maternal death. The use of tocotonic drugs following delivery is routine practice as part of the active management of the third stage of labor, to increase uterine tone and reduce blood loss. However, the use of these drugs is not without side effects and complications. Oxytocin causes profound vasodilatation, hypotension and increased cardiac output and has been associated with chest pain, reduced arterial oxygen saturation and ST segment changes on ECG. Ergometrine, on the other hand, causes systemic vasoconstriction and hypertension, and reduced cardiac output. As oxytocin and ergometrine are associated with opposing hemodynamic sequelae, there is a rationale to justify the co-administration of both of these drugs in an attempt to cancel out their side effects.
No clinical studies have attempted to titrate the dose of tocotonic drugs against a quantified measure of uterine tone. As a consequence, comparisons of the hemodynamic side effects of oxytocin and other tocotonic agents (particularly ergometrine) have not been based on a knowledge of equipotential doses, making the rational comparison of side effects impossible.
In this study we hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone. In order to perform this study we perform the following steps:
- We validate a quantitative measure of uterine tone as our primary endpoint. 2) We use this endpoint measure in order to determine equipotential doses of different tocotonic drug regimens, based on the ED50 for each. 3) Using equipontial ratios based on the ED50, we compare hemodynamic and other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be measured to enable pharmacokinetic-pharmacodynamic assessments to be made.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Oxytocin versus oxytocin-ergometrine
- Keywords
- Pregnancy, Postpartum hemorrhage, Uterine tone, Oxytocin, Ergometrine, Pharmacokinetic-pharmacodynamic analysis
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin versus oxytocin-ergometrineDrug
Group 1: Oxytocin 0.1 I.U./kg/hr (plain) Group 2: Oxytocin 0.1 I.U./kg/hr with ergometrine 2 mcg/kg/hr co-administered Infusion rates determined to achieve equipotential doses based on an earlier PKPD study
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Not described Receives: Drug: Oxytocin versus oxytocin-ergometrine |
| Oxytocin - ergometrine | Experimental | Not described Receives: Drug: Oxytocin versus oxytocin-ergometrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine tone
Uterine tone as measured by tissue durometry
Measured: Up to 30 minutes
Secondary outcomes (2)
Plasma levels of oxytocin
Measured: Up to 30 minutes
Subjective side effects
Headache, chest pain, shortness of breath
Measured: Up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236482
- Sponsor's protocol ID
- oxytocined50-HMO-CTIL
- Status last verified
- Sep 2010
- First submitted
- 27 Sep 2010
- Last updated
- 8 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Oxytocin and Oxytocin-ergometrine Combinations for Increasing Uterine Tone in Cesarean Delivery: a Pharmacokinetic-pharmacodynamic Study.
- ClinicalTrials.gov ID
- NCT01236482
- Acronym / sponsor ID
- oxytocined50-HMO-CTIL
- Conditions
- Post Partum Hemorrhage
- Keywords
- Pregnancy, Postpartum hemorrhage, Uterine tone, Oxytocin, Ergometrine, Pharmacokinetic-pharmacodynamic analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 8 Nov 2010 (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.
In this study the investigators hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone. In order to perform this study the investigators perform the following steps:
- The investigators validate a quantitative measure of uterine tone as our primary endpoint.
- The investigators use this endpoint measure in order to determine equipotential doses of different tocotonic drug regimens, based on the ED50 for each.
- Using equipontial ratios based on the ED50, the investigators compare hemodynamic and other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be measured.
Detailed description
Obstetric hemorrhage is associated with severe maternal morbidityש and maternal death. The use of tocotonic drugs following delivery is routine practice as part of the active management of the third stage of labor, to increase uterine tone and reduce blood loss. However, the use of these drugs is not without side effects and complications. Oxytocin causes profound vasodilatation, hypotension and increased cardiac output and has been associated with chest pain, reduced arterial oxygen saturation and ST segment changes on ECG. Ergometrine, on the other hand, causes systemic vasoconstriction and hypertension, and reduced cardiac output. As oxytocin and ergometrine are associated with opposing hemodynamic sequelae, there is a rationale to justify the co-administration of both of these drugs in an attempt to cancel out their side effects.
No clinical studies have attempted to titrate the dose of tocotonic drugs against a quantified measure of uterine tone. As a consequence, comparisons of the hemodynamic side effects of oxytocin and other tocotonic agents (particularly ergometrine) have not been based on a knowledge of equipotential doses, making the rational comparison of side effects impossible.
In this study we hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone. In order to perform this study we perform the following steps:
- We validate a quantitative measure of uterine tone as our primary endpoint. 2) We use this endpoint measure in order to determine equipotential doses of different tocotonic drug regimens, based on the ED50 for each. 3) Using equipontial ratios based on the ED50, we compare hemodynamic and other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be measured to enable pharmacokinetic-pharmacodynamic assessments to be made.
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 |
|---|---|---|
| Oxytocin | Active comparator | Drug: Oxytocin versus oxytocin-ergometrine |
| Oxytocin - ergometrine | Experimental | Drug: Oxytocin versus oxytocin-ergometrine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 80 healthy women presenting for elective repeat cesarean delivery under regional anesthesia.
- All women are ASA class 1-2, aged 18 - 45, with body weight 60-100 kg.
Key exclusion criteria (3 listed)
- Obstetric risk factors: Pre-eclampsia, abnormalities of placentation (eg placenta accrete, placenta previa), amnionitis, multiple gestation, preterm delivery (< 37 completed weeks), more than three previous cesarean deliveries, previous history of ante-partum or post-partum hemorrhage.
- Maternal medical risk factors: Chronic hypertension, cardiac disease, intracranial pathology, known allergies to oxytocin or ergometrine, autoimmune disorders, SLE, coagulation defect or anticoagulation therapy, amnionitis.
- Women asking for cord blood donations are not included in this study due to the long elapsed time between delivery and the commencement of oxytocin.
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 versus oxytocin-ergometrineGroup 1: Oxytocin 0.1 I.U./kg/hr (plain) Group 2: Oxytocin 0.1 I.U./kg/hr with ergometrine 2 mcg/kg/hr co-administered Infusion rates determined to achieve equipotential doses based on an earlier PKPD study | Drug | Oxytocin, Oxytocin - ergometrine |
Primary outcome
Uterine tone
Time frame: Up to 30 minutes
Uterine tone as measured by tissue durometry
2 secondary outcomes
Plasma levels of oxytocin
Time frame: Up to 30 minutes
Subjective side effects
Time frame: Up to 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2010.
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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.
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 versus oxytocin-ergometrine in people with Post Partum Hemorrhage, run by Hadassah Medical Organization at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine tone (time frame: Up to 30 minutes). 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 8 Nov 2010.