Trial · Interventional

CompletedPhase 4Results postedRegistry data

Oxytocin And Uterotonic Agent Use For Cesarean Delivery

NCTNCT01549223Other id2010-P-002284

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 60 participants (actual)
Sponsor: Brigham and Women's Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Apr 2011
Primary completion: Jan 2012
Completion: Jan 2012
First posted: 9 Mar 2012 (estimated)
Last update posted: 29 Jun 2017
Conditions: Uterine Atony · Hypotension

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201120122013

Ph 4
Oxytocin And Uterotonic Agent Use For Cesarean Delivery
NCT01549223
Apr 2011 to Jan 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Oxytocin InfusionDrug
Oxytocin BolusDrug

Arms2

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.
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(1)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Up to 15 min from time of infant delivery

1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.

Group	Value (IU)	Spread
Standard Care Group	8.4	4.8
Protocol Group	4.0	0.9

Secondary and other outcome results(1)

Secondary outcomeCount of participants· Up to 15 min from time of infant delivery

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

Group	Value (Participants)
Standard Care Group	3
Protocol Group	2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
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 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. Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.	0 / 30	0 / 30	0 / 30
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. Oxytocin: 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).	0 / 30	0 / 30	0 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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