Oxytocin And Uterotonic Agent Use For Cesarean Delivery

NCT ID: NCT01549223

Last Updated: 2017-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-01-31

Brief Summary

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

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.

Conditions

Uterine Atony; Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Oxytocin Infusion

Intervention Type: DRUG

500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.

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.

Group Type: ACTIVE_COMPARATOR

Oxytocin Bolus

Intervention Type: DRUG

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).

Interventions

Oxytocin Infusion

500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

methylergonovine maleate (methergine) 0.2 mg IM; carboprost tromethamine (hemabate) 0.25 mg IM; misoprostol 600 mcg buccally; methylergonovine maleate (methergine) 0.2 mg IM; carboprost tromethamine (hemabate) 0.25 mg IM; misoprostol 600 mcg buccally

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Ching Tsen

Vice Chair, Faculty Development and Education; Associate Professor, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence C Tsen, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital/Harvard Medical School

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010-P-002284

Identifier Type: -

Identifier Source: org_study_id