Oxytocin And Uterotonic Agent Use For Cesarean Delivery

A Randomized Controlled Trial of Standardized Versus Conventional Oxytocin and Uterotonic Agent Use for Cesarean Delivery

The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery

The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective cesarean delivery will:

1. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone.

Secondary outcomes to be evaluated will be:

1. Reduce the side effects associated with uterotonic drug use
2. Reduce the time to establishment and maintenance of adequate uterine tone

Study Overview

• Status: Completed
• Conditions: Hypotension; Uterine Atony
• Intervention / Treatment: Drug: Oxytocin Infusion; Drug: Oxytocin Bolus

Detailed Description

The current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague. A stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner. This algorithm should encompass laboring and non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other uterotonic agents.

More specifically, the investigators believe that the following points should be incorporated into a protocol: 1) oxytocin should be used in initial doses of less than 5 IU; 2) oxytocin should not be administered as a rapid IV bolus; 3) an initial rapid infusion of oxytocin should be followed by a maintenance infusion; 4) higher initial and infusion doses of oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin is not producing effective uterine contractions, other uterotonic drugs acting via different pathways should be considered in a standardized way.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) I or II health status
• Age between 18 and 50 yrs
• Singleton pregnancies in vertex position
• Elective (without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision

Exclusion Criteria:

• Conditions that predispose to uterine atony and postpartum hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard Care Group; "Standard Care Group" (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion "oxytocin". If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM (intramuscular) or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded. If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.	Drug: Oxytocin Infusion; 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.; Other Names: methylergonovine maleate (methergine) 0.2 mg IM; carboprost tromethamine (hemabate) 0.25 mg IM; misoprostol 600 mcg buccally
ACTIVE_COMPARATOR: Protocol Group; "Protocol Group" will receive 3 mL syringes marked "study solution-oxytocin" which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale). If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked "study solution-9 min", containing methylergonovine maleate (methergine) 0.2mg, will be given IM. If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked "study solution-12 min", containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM. If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.	Drug: Oxytocin Bolus; 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).; Other Names: methylergonovine maleate (methergine) 0.2 mg IM; carboprost tromethamine (hemabate) 0.25 mg IM; misoprostol 600 mcg buccally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.	Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.	Up to 15 min from time of infant delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use	Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.	Up to 15 min from time of infant delivery

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Lawrence C Tsen, MD, Brigham and Women's Hospital/Harvard Medical School

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: March 3, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (ESTIMATE): March 9, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Hypotension; Cesarean Delivery; Hemorrhage; Ephedrine; Phenylephrine; Uterine Atony
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Obstetric Labor Complications; Dystocia; Hypotension; Uterine Inertia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Maleic acid; Oxytocin; Misoprostol; Carboprost; Carboprost tromethamine; Methylergonovine
• Other Study ID Numbers: 2010-P-002284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes