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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869556
• Other study ID #: 13-05
• Status: Completed
• Phase: N/A
• Start date: June 4, 2013
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2020
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 30, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystocia
• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours
• Ergot
Ergot 0.25mg IV
• Carboprost
Carboprost 0.25mg IM

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for additional uterotonics intraoperatively	Need for additional uterotonics intraoperatively if requested by the surgeon, YES or NO	1 hour
Secondary	Effectiveness of uterine contraction	Adequate/inadequate uterine tone at 3,5 & 10 min	10 min
Secondary	Need for blood transfusion	Any blood products administered	24 hours
Secondary	Vital signs	In the OR, heart rate, blood pressure, and oxygen saturation will be measured and looked at for abnormalities	2 hours
Secondary	Side effects	The presence of nausea, vomiting,other dysrhythmias, chest pain, headache, bronchospasm and any others will be recorded.	24 hours
Secondary	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
Secondary	Need for additional uterotonics or interventions post-operatively	Need for additional uterotonics or interventions post-operatively up to 24 hours post-partum	24 hours