Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress

Study Overview
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Brief Summary
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Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.

Detailed Description
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The objective of the investigators study is to compare the efficacy of intravenous ergonovine and intramuscular carboprost, when administered with oxytocin infusion, prophylactically to decrease blood loss at Cesarean section for labor arrest. Desensitization of the oxytocin receptors has been recently demonstrated in cultured human myometrial cells after continuous and prolonged exposure to oxytocin in-vitro. This could be also the reason for a greater risk of uterine atony and postpartum hemorrhage (PPH) seen in women requiring induction and augmentation of labor. Therefore, addition of a different uterotonic agent, involving a different mechanism of action, to oxytocin infusion is likely to be beneficial, especially in women undergoing CS following failure to progress in labor, who are at a greater risk for PPH.

Official Title
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Comparison of Intravenous Ergonovine With Intramuscular Carboprost, Both in Combination With Oxytocin Infusion, During Cesarean Section for Failure to Progress in Labor: A Double-blinded Placebo-controlled Randomized Controlled Trial

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Ergot
* Drug: Carboprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who give written informed consent patients undergoing Cesarean section for failure to progress in labour, under regional anesthesia patients should be in the first stage of labour and have received oxytocin for at least 4 hours Exclusion Criteria: patients who refuse to give written informed consent patients who require general anesthesia patients who claim allergy or hypersensitivity to oxytocin, ergot derivatives or prostaglandins patients with cardiac diseases and hypertension or preeclampsia ( diastolic blood pressure > 90 mmHg, systolic blood pressure > 140 mmHg ) patients with asthma or any other respiratory disease patients with conditions at risk of PPH such as placenta previa, multiple gestation, preeclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, bleeding diathesis and known infection.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin only<br>Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours | Drug: Oxytocin<br>* Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours<br>* Other names: syntocinon;|
| Active Comparator: Oxytocin + Ergot<br>Oxytocin 5IU IV bolus + Ergot 0.25mg IV, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours | Drug: Oxytocin<br>* Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours<br>* Other names: syntocinon;Drug: Ergot<br>* Ergot 0.25mg IV<br>* Other names: ergonovine maleate;|
| Active Comparator: Oxytocin + Carboprost<br>Oxytocin 5IU IV bolus + Carboprost 0.25mg IM, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours | Drug: Oxytocin<br>* Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours<br>* Other names: syntocinon;Drug: Carboprost<br>* Carboprost 0.25mg IM<br>* Other names: Hemabate®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for additional uterotonics intraoperatively | Need for additional uterotonics intraoperatively if requested by the surgeon, YES or NO | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of uterine contraction | Adequate/inadequate uterine tone at 3,5 & 10 min | 10 min | 
| Need for blood transfusion | Any blood products administered | 24 hours | 
| Vital signs | In the OR, heart rate, blood pressure, and oxygen saturation will be measured and looked at for abnormalities | 2 hours | 
| Side effects | The presence of nausea, vomiting,other dysrhythmias, chest pain, headache, bronchospasm and any others will be recorded. | 24 hours | 
| Estimated blood loss | calculated blood loss = EBV (Pre-op Htc-Post-op Htc) EBV (estimated blood volume, mL)=patient's weight in kg x 85 | 48 hours | 
| Need for additional uterotonics or interventions post-operatively | Need for additional uterotonics or interventions post-operatively up to 24 hours post-partum | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, postpartum hemorrhage, Cesarean delivery, failure to progress in labor