Clinical trial NCT00481533: Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
Official title: Prophylactic Ergonovine-Oxytocin Versus Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss, Surgical
Keywords: Cesarean Delivery
Uterine Contractility
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood loss
timeFrame: During surgery
Secondary outcomes:
measure: Effectiveness of Uterine Contraction
timeFrame: During surgery
measure: Side Effects
timeFrame: During surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose CA Carvalho, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.