Maintenance Infusion of Oxytocin Following Elective Cesarean Deliveries

Status Completed

Clinical Trial Summary

This study is designed to determine the minimal effective oxytocin maintenance dose required during cesarean delivery to achieve the best effect. Oxytocin is a drug which is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta. The aim of oxytocin is to reduce the amount of blood that might be lost. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. If the uterus contracts well, this is considered satisfactory and the next patient will receive the same dose. If the uterus does not contract well, this is considered unsatisfactory and the next patient will receive a higher dose. The dose for the next patient will be determined based on the results of the uterine contraction of the previous patient. The investigators hypothesize that the ED90 of an oxytocin infusion rate to maintain a satisfactory uterine tone during a cesarean delivery in non-laboring women, would be lower than that found in previous studies without an initial bolus (less than 16 IU/h).

Clinical Trial Description

This study will be conducted as a prospective, double blinded clinical trial (patient, anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential allocation fashion. The objective of the study is to determine the minimum effective dose of oxytocin infusion required to produce appropriate uterine contraction during and after cesarean delivery under neuraxial anesthesia in non-laboring women. For the purpose of this study, the minimum effective dose is defined to be that at which adequate response occurs in 90% of patients, i.e. ED90. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04946006
Study type	Interventional
Source	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Contact
Status	Completed
Phase	N/A
Start date	July 26, 2021
Completion date	April 2, 2022

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
Not yet recruiting	`NCT02319707` - Management of the Third Stage of Labor	Phase 3
Completed	`NCT02163616` - Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study	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
Not yet recruiting	`NCT02853552` - Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding	Phase 4
Completed	`NCT03344302` - Oxytocin Administration During Cesarean Section	Phase 4
Completed	`NCT02910310` - Introduction of UBT for PPH Management in Three Countries	N/A