Blood Loss, SurgicalNCT00481533
Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
A study testing Methyl-Ergonovine-Oxytocin and Oxytocin in people with Blood Loss, Surgical, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Despite of marked improvements in clinical management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Methyl-Ergonovine-Oxytocin and Oxytocin
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Jan 2007
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cesarean section secondary to failure to progress in labour
- First stage of labour
- Received oxytocin for at least 4 hours
Who cannot join
- Require General Anesthesia
- Cardiac Disease
- Hypertension
- Predisposition to uterine atony and postpartum hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Ergonovine-Oxytocin Versus Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
Despite of marked improvements in clinical management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in the obstetric patient. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health.
Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.
Read the detailed description
Despite of marked improvements in management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in Obstetrics. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health.
Prophylactic oxytocin, commonly administered after fetal and placental delivery, has been shown to reduce the incidence of PPH. The main advantages of this drug are its rapid onset of action and the fact that it does not cause elevations of blood pressure or tetanic contractions like ergonovine. The effect of oxytocin is limited by the number and status of the oxytocin receptors. Increases in the dose of oxytocin will not necessarily improve uterine contraction, if receptors are not adequate in quantity and quality.This is the cause of patients exposed to oxytocin for labor augmentation, in whom oxytocin receptors are known to reduce both number and response to oxytocin. Therefore, a different uterotonic agent, involving a different mechanism of action should be used instead. Alternative drugs include ergot derivatives and prostaglandins (carboprost and misoprostol). Although protection from PPH with ergot derivatives and prostaglandin appear to be similar, prostaglandins are associated with more side effects.
Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.
- Conditions
- Blood Loss, Surgical
- Being tested
- Methyl-Ergonovine-Oxytocin, Oxytocin
- Keywords
- Cesarean Delivery, Uterine Contractility
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl-Ergonovine-OxytocinDrug
OxytocinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Measured: During surgery
Secondary outcomes (2)
Effectiveness of Uterine Contraction
Measured: During surgery
Side Effects
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startJun 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose CA Carvalho, MD PhD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481533
- Sponsor's protocol ID
- 07-07
- Other IDs
- 05-0042-A
- Status last verified
- May 2007
- First submitted
- 30 May 2007
- Last updated
- 1 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Balki M, Dhumne S, Kasodekar S, Kingdom J, Windrim R, Carvalho JC. Oxytocin-ergometrine co-administration does not reduce blood loss at caesarean delivery for labour arrest. BJOG. 2008 Apr;115(5):579-84. doi: 10.1111/j.1471-0528.2007.01658.x.
PubMed 18333937
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Ergonovine-Oxytocin Versus Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
- ClinicalTrials.gov ID
- NCT00481533
- Acronym / sponsor ID
- 07-07
- Conditions
- Blood Loss, Surgical
- Keywords
- Cesarean Delivery, Uterine Contractility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 1 Jun 2007 (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.
Despite of marked improvements in clinical management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in the obstetric patient. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health.
Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.
Detailed description
Despite of marked improvements in management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in Obstetrics. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health.
Prophylactic oxytocin, commonly administered after fetal and placental delivery, has been shown to reduce the incidence of PPH. The main advantages of this drug are its rapid onset of action and the fact that it does not cause elevations of blood pressure or tetanic contractions like ergonovine. The effect of oxytocin is limited by the number and status of the oxytocin receptors. Increases in the dose of oxytocin will not necessarily improve uterine contraction, if receptors are not adequate in quantity and quality.This is the cause of patients exposed to oxytocin for labor augmentation, in whom oxytocin receptors are known to reduce both number and response to oxytocin. Therefore, a different uterotonic agent, involving a different mechanism of action should be used instead. Alternative drugs include ergot derivatives and prostaglandins (carboprost and misoprostol). Although protection from PPH with ergot derivatives and prostaglandin appear to be similar, prostaglandins are associated with more side effects.
Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cesarean section secondary to failure to progress in labour
- First stage of labour
- Received oxytocin for at least 4 hours
Key exclusion criteria (4 listed)
- Require General Anesthesia
- Cardiac Disease
- Hypertension
- Predisposition 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 |
|---|---|---|
| Methyl-Ergonovine-Oxytocin | Drug | – |
| Oxytocin | Drug | – |
Primary outcome
Blood loss
Time frame: During surgery
2 secondary outcomes
Effectiveness of Uterine Contraction
Time frame: During surgery
Side Effects
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2007.
- Derived from this study: PubMed 18333937Balki M, Dhumne S, Kasodekar S, Kingdom J, Windrim R, Carvalho JC. Oxytocin-ergometrine co-administration does not reduce blood loss at caesarean delivery for labour arrest. BJOG. 2008 Apr;115(5):579-84. doi: 10.1111/j.1471-0528.2007.01658.x.
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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.
Jose CA Carvalho, MD PhD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methyl-Ergonovine-Oxytocin and Oxytocin in people with Blood Loss, Surgical, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 4 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 1 Jun 2007. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood loss (time frame: During surgery). 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 NCT00481533, 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 1 Jun 2007.