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

NCT01869556 | Completed

• 1 other identifier: 13-05
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage

Keywords

pregnancy; postpartum hemorrhage; Cesarean delivery; failure to progress in labor

Outcome Measures

Primary Outcomes (1)

• Need for additional uterotonics intraoperatively

  Need for additional uterotonics intraoperatively if requested by the surgeon, YES or NO

  1 hour

Secondary Outcomes (6)

• Effectiveness of uterine contraction

  10 min

• Need for blood transfusion

  24 hours

• Vital signs

  2 hours

• Side effects

  24 hours

• Estimated blood loss

  48 hours

Study Arms (3)

Oxytocin only

ACTIVE COMPARATOR

Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours

Drug: Oxytocin

Oxytocin + Ergot

ACTIVE COMPARATOR

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; Drug: Ergot

Oxytocin + Carboprost

ACTIVE COMPARATOR

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; Drug: Carboprost

Interventions

Oxytocin DRUG

Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours

Also known as: syntocinon

Oxytocin + Carboprost; Oxytocin + Ergot; Oxytocin only

Ergot DRUG

Ergot 0.25mg IV

Also known as: ergonovine maleate

Oxytocin + Ergot

Carboprost DRUG

Carboprost 0.25mg IM

Also known as: Hemabate®

Oxytocin + Carboprost

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Balki M, Downey K, Walker A, Seaward G, Carvalho JCA. Prophylactic Administration of Uterotonics to Prevent Postpartum Hemorrhage in Women Undergoing Cesarean Delivery for Arrest of Labor: A Randomized Controlled Trial. Obstet Gynecol. 2021 Mar 1;137(3):505-513. doi: 10.1097/AOG.0000000000004288.

  PMID: 33543897 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; Ergonovine; Carboprost; carboprost tromethamine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 5, 2013
• Study Start: June 4, 2013
• Primary Completion: July 8, 2019
• Study Completion: September 30, 2019
• Last Updated: September 24, 2020

Record last verified: 2020-09

Locations

CA (1)