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Completed

NCT Number: NCT01549223

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

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Key information

Conditions

Uterine Atony Cardiovascular Diseases Dystocia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Hypotension Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases Uterine Inertia Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin Infusion

Drug

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

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).

Other names: methylergonovine maleate (methergine) 0.2 mg IM, carboprost tromethamine (hemabate) 0.25 mg IM, misoprostol 600 mcg buccally

Primary outcomes

  1. 1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.

    Time frame: Up to 15 min from time of infant delivery

    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

    Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2012
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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