Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01869556
Study type	Interventional
Source	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Contact
Status	Completed
Phase	N/A
Start date	June 4, 2013
Completion date	September 30, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03434444` - In Vitro Optimization of Oxytocin-induced Myometrial Contractility by Propranolol	N/A
Terminated	`NCT01980173` - Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care	N/A
Not yet recruiting	`NCT06033170` - Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage	N/A
Completed	`NCT02163616` - Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study	Phase 3
Not yet recruiting	`NCT02319707` - Management of the Third Stage of Labor	Phase 3
Recruiting	`NCT01600612` - Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial	N/A
Completed	`NCT02079558` - Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section	Phase 2
Withdrawn	`NCT01108302` - Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India	N/A
Completed	`NCT00097123` - RCT of Misoprostol for Postpartum Hemorrhage in India	N/A
Completed	`NCT02883673` - Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage	N/A
Completed	`NCT02542813` - Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers	Phase 1
Completed	`NCT04201665` - EMG for Uterotonic Efficiency Estimation	N/A
Terminated	`NCT03246919` - Ideal Time of Oxytocin Infusion During Cesarean Section	Phase 4
Not yet recruiting	`NCT05501106` - Reducing Postpartum Hemorrhage After Vaginal Delivery	N/A
Completed	`NCT05429580` - Prophylactic Tranexamic Acid Use After Vaginal Delivery	N/A
Terminated	`NCT03064152` - Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery	N/A
Recruiting	`NCT05382403` - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage	N/A
Completed	`NCT02910310` - Introduction of UBT for PPH Management in Three Countries	N/A
Completed	`NCT03344302` - Oxytocin Administration During Cesarean Section	Phase 4
Completed	`NCT02805426` - Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms