Oxytocin And Uterotonic Agent Use For Cesarean Delivery

NCT01549223 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2010-P-002284
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Uterine Atony; Hypotension

Keywords

Uterine Atony; Hypotension; Cesarean Delivery; Hemorrhage; Phenylephrine; Ephedrine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use

  Up to 15 min from time of infant delivery

Study Arms (2)

Standard Care Group

ACTIVE COMPARATOR

"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

Protocol Group

ACTIVE COMPARATOR

"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

Interventions

Oxytocin Infusion DRUG

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

Also known as: methylergonovine maleate (methergine) 0.2 mg IM, carboprost tromethamine (hemabate) 0.25 mg IM, misoprostol 600 mcg buccally

Standard Care Group

Oxytocin Bolus 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).

Also known as: methylergonovine maleate (methergine) 0.2 mg IM, carboprost tromethamine (hemabate) 0.25 mg IM, misoprostol 600 mcg buccally

Protocol Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Conditions that predispose to uterine atony and postpartum hemorrhage

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Uterine Inertia; Hypotension; Hemorrhage

Interventions

Methylergonovine; carboprost tromethamine; Misoprostol

Condition Hierarchy (Ancestors)

Dystocia; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ergonovine; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Lawrence Tsen, MD
• Organization: Brigham and Women's Hospital

ltsen@partners.org

617-732-8216

Study Officials

• Lawrence C Tsen, MD

  Brigham and Women's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Faculty Development and Education; Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: March 3, 2012
• First Posted: March 9, 2012
• Study Start: April 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)