An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

NCT02410655 | Withdrawn Phase 4 DMC

• 1 other identifier: 16-00279
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.

Conditions

Uterine Atony; Postpartum Hemorrhage

Keywords

Uterine atony; Postpartum hemorrhage; Vaginal delivery; Uterotonic; Oxytocin; Bolus; Evidence-based; Protocol

Outcome Measures

Primary Outcomes (1)

• Estimated blood loss

  24 hours postpartum

Study Arms (2)

Conventional standard of care

ACTIVE COMPARATOR

Traditional administration of oxytocin at Lutheran Medical Center involves the use of two 20 IU / 1000 mL bags hung sequentially at a flow rate of 125 mL / hour each after the delivery of the anterior shoulder. This will total no more than 16 hours.

Drug: Oxytocin

Evidence based protocol

ACTIVE COMPARATOR

The proposed evidence based protocol involves utilizing a single 30IU / 500mL bag of oxytocin. After the delivery of the anterior shoulder, an initial rapid infusion bolus of 50mL of the 30IU / 500mL at 999mL / hour. Three minutes after rapid infusion, uterine tone should be assessed. If inadequate uterine tone persists, a second rapid infusion at the same dose and rate as above should be given. If inadequate uterine tone persists, a third rapid infusion may be given. If adequate uterine tone is achieved after any rapid infusion, the remainder of the bag should be administered at a rate of 100mL / hour until finished. If adequate tone is not achieved, the remainder of the bag should be administered at 100mL / hour and additional uterotonic agents should be considered.

Drug: Oxytocin

Interventions

Oxytocin DRUG

500 mL bag of oxytocin (30 IU / 500 mL) to be connected to the IV, and controlled at the obstetricians request. Up to two, 50 mL rapid infusion boluses to be given after delivery of anterior shoulder. Upon completing the bolus(es) flow rate should be continued at 100 mL / hour. This should total no more than 4.5 hours.

Also known as: Pitocin

Evidence based protocol

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Vaginal Delivery

You may not qualify if:

• Cesarean Delivery
• Allergy to Oxytocin
• Cardiac Arrhythmia

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Uterine Inertia; Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Dystocia; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Violetta Lozovyy, MD

  Lutheran Medical Center

  PRINCIPAL INVESTIGATOR

• Jade King, BS

  Lutheran Medical Center

  PRINCIPAL INVESTIGATOR

• Roulhac D Toledano, MD, PhD

  Lutheran Medical Center

  STUDY DIRECTOR

• Kevin Fitzpatrick, MD

  Lutheran Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 7, 2015
• Study Start: November 1, 2015
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2017
• Last Updated: July 31, 2017

Record last verified: 2017-07