Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Blood Loss, Surgical |
Drug: Methyl-Ergonovine-Oxytocin Drug: Oxytocin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Prophylactic Ergonovine-Oxytocin Versus Oxytocin During Cesarean Delivery Following Failure to Progress in Labour |
- Blood loss [ Time Frame: During surgery ]
- Effectiveness of Uterine Contraction [ Time Frame: During surgery ]
- Side Effects [ Time Frame: During surgery ]
| Enrollment: | 47 |
| Study Start Date: | June 2005 |
| Study Completion Date: | January 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Cesarean section secondary to failure to progress in labour
- First stage of labour
- Received oxytocin for at least 4 hours
Exclusion Criteria:
- Require General Anesthesia
- Cardiac Disease
- Hypertension
- Predisposition to uterine atony and postpartum hemorrhage
Contacts and Locations| Canada, Ontario | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Principal Investigator: | Jose CA Carvalho, MD PhD | Mount Sinai Hospital, New York |
More Information
No publications provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00481533 History of Changes |
| Other Study ID Numbers: | 07-07, 05-0042-A |
| Study First Received: | May 30, 2007 |
| Last Updated: | May 30, 2007 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
|
Cesarean Delivery Uterine Contractility |
Additional relevant MeSH terms:
|
Hemorrhage Blood Loss, Surgical Pathologic Processes Intraoperative Complications Ergonovine Oxytocin |
Oxytocics Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013