Oxytocin Dosing at Planned Cesarean Section and Anemia

NCT03361124 | Withdrawn Phase 4 DMC

• 1 other identifier: 00006502
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patient's with planned cesarean sections will be randomized to receive either standard 20 mU in 1L as a bolus following delivery of the placenta or 20 mu in 1L following delivery of the placenta plus an additional 20 mU in 1L over 8 hours.

Conditions

Blood Loss Anemia; Uterine Atony With Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Blood loss in postpartum period defined by grams/hour

  Measure pads used post-partum

  3-4 days after delivery

Secondary Outcomes (10)

• Change in Hemoglobin

  24 hours

• Change in Hematocrit

  24 hours

• Length of hospital stay

  3-4 days after delivery

• Need for additional uterotonics

  24 hours after delivery

• Continuation of breastfeeding

  6 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.

Drug: Oxytocin

Treatment

EXPERIMENTAL

Patient will receive standard post-partum Oxytocin(20 mU in 1 L LR) an additional 20 mU Oxytocin in 1 L LR over 8 hours following delivery.

Drug: Oxytocin

Interventions

Oxytocin DRUG

Administration of additional 20 mU Oxytocin

Also known as: Pitocin

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned cesarean sections for singletons at or greater than 37 weeks gestational age
• Primary or repeat cesarean section will be included

You may not qualify if:

• Multiple fetal pregnancies
• Hematologic disorders
• Fetal anomalies
• Pre-eclampsia. These patients are at increased risk of fluid overload and so fluid status may be affected by receiving a second bag of fluid containing oxytocin in the postpartum period.
• Known contraindication to oxytocin
• Hypersensitivity to oxytocin
• Patients who have labored and then proceed with cesarean section for any reason. Patients who have labored have had either intrinsic or extrinsic exposure to oxytocin. These patients may have decreased sensitivity to oxytocin.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Interventions

Oxytocin

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

• Helana Pietragallo, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Covering of labels on IV fluids
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized double-blinded controlled

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: December 4, 2017
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 21, 2019

Record last verified: 2019-02