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Oxytocin Dosing at Planned Cesarean Section and Anemia

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ClinicalTrials.gov Identifier: NCT03361124
Recruitment Status : Withdrawn (Investigator no longer interested in proceeding with study)
First Posted : December 4, 2017
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Helana Pietragallo, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Blood Loss Anemia Uterine Atony With Hemorrhage Drug: Oxytocin Phase 4

Detailed Description:

The purpose of this study is to examine the impact of differential dose protocols commonly utilized in the post cesarean period to determine if laboratory definitions of anemia are different. Oxytocin is an antidiuretic hormone that is utilized after delivery of the fetus and placenta to contract the uterus and decrease blood loss both at the time of surgery and in the post-partum period. Here at the Penn State Hershey Medical center the investigators will use 20 units of oxytocin in a 1 L bag of LR in bolus fashion after delivery of the placenta. Other protocols use an extended course of therapy using 20 units of oxytocin in a 1 L bag of LR in a bolus plus an additional 20 units of oxytocin in a 1 L bag of LR over an 8 hour period of time.

We hypothesize that:

  • Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have a decreased reduction in pre-operative vs post-operative hematocrit and hemoglobin versus those that receive 20 mU in 1L of LR.
  • Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have decreased blood loss by weight in the postpartum period compared to patients who receive 20 mU in 1L of LR.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double-blinded controlled
Masking: Double (Participant, Investigator)
Masking Description: Covering of labels on IV fluids
Primary Purpose: Prevention
Official Title: Oxytocin Dosing at Planned Cesarean Section and Postpartum Anemia: A Comparison of Two Protocols
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Placebo Comparator: Control
Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.
Drug: Oxytocin
Administration of additional 20 mU Oxytocin
Other Name: Pitocin

Experimental: Treatment
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
Administration of additional 20 mU Oxytocin
Other Name: Pitocin




Primary Outcome Measures :
  1. Blood loss in postpartum period defined by grams/hour [ Time Frame: 3-4 days after delivery ]
    Measure pads used post-partum


Secondary Outcome Measures :
  1. Change in Hemoglobin [ Time Frame: 24 hours ]
    Pre-op hemoglobin and post-op hemoglobin

  2. Change in Hematocrit [ Time Frame: 24 hours ]
    Pre-op hematocrit and post-op hematocrit

  3. Length of hospital stay [ Time Frame: 3-4 days after delivery ]
    Start of surgery to discharge (hours)

  4. Need for additional uterotonics [ Time Frame: 24 hours after delivery ]
    Use of uterotonics

  5. Continuation of breastfeeding [ Time Frame: 6 weeks ]
    Is patient breastfeeding at 6 week post-partum visit

  6. Quantity of narcotic pain medications [ Time Frame: 3-4 days after delivery ]
    Number of narcotic tablets used from time of surgery to discharge

  7. Attendance at post-partum visit [ Time Frame: 6 weeks ]
    Did patient attend post-partum visit?

  8. Post-partum complications [ Time Frame: 6 weeks ]
    Did patient have surgical wound infection, endometritis?

  9. Need for blood transfusion [ Time Frame: 3-4 days after delivery ]
    Did the patient require blood transfusion?

  10. Edinburgh post-partum depression scale >10 [ Time Frame: 6 weeks ]
    Did the patient score greater than 10 points on Edinburgh post-partum depression scale?



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361124


Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Helana Pietragallo, MD Penn State College of Medicine

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Responsible Party: Helana Pietragallo, Assistant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03361124     History of Changes
Other Study ID Numbers: 00006502
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Uterine Inertia
Anemia
Hemorrhage
Hematologic Diseases
Pathologic Processes
Dystocia
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs