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Ideal Time of Oxytocin Infusion During Cesarean Section (I-TOPICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03246919
Recruitment Status : Terminated (PI left Loyola and Sub-I graduated.)
First Posted : August 11, 2017
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Loyola University

Brief Summary:
This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Postpartum Hemorrhage Bleed Pregnancy Pregnancy Related Cesarean Section Complications Drug: Oxytocin Drug: Placebo Phase 4

Detailed Description:

Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States. This medication helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries.

This study will evaluate both estimated and quantitative blood loss for both groups of patients. It will also compare the change from pre-operative to post-operative hemoglobin levels.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blind: Obstetricians, Anesthesiologists and patients will be blinded. Only nurses will be aware of timing of oxytocin administration
Primary Purpose: Treatment
Official Title: Ideal Time of Oxytocin Infusion During Cesarean Section
Actual Study Start Date : September 13, 2017
Actual Primary Completion Date : February 24, 2020
Actual Study Completion Date : February 24, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Placebo Comparator: Control (Group A)
One bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia. This amount of fluid is part of standard of care.
Drug: Placebo
Placebo will be administered after delivery of the placenta

Active Comparator: Intervention (Group B)
One bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia. This amount of fluid is part of standard of care.
Drug: Oxytocin
Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
Other Name: Pitocin




Primary Outcome Measures :
  1. Total blood loss [ Time Frame: At the completion of the surgery when patient is transferred to recovery from the operating room ]
    Both the estimated blood loss and quantitative blood loss will be determined


Secondary Outcome Measures :
  1. Incidence of postpartum hemorrhage [ Time Frame: At the completion of the surgery when patient is transferred to recovery from the operating room ]
    The number of women who lose 1,000 milliliters or more blood from cesarean delivery

  2. Need for transfusion [ Time Frame: In the immediate 24 hours post surgery ]
    The number of women who require a blood transfusion due to surgical blood loss

  3. Change in pre-operative to post-operative hemoglobin levels [ Time Frame: Baseline and Post operative day number 1 ]
    Hemoglobin levels



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Women undergoing cesarean section at Loyola Hospital
  • Women who read and speak the English and/or Spanish language
  • Women age 18 or older

Exclusion Criteria:

  • Women who deliver vaginally
  • Gestation under 37 weeks and 0 days
  • Women with coagulopathies
  • Multiple gestation pregnancies
  • Antepartum hemorrhage for example abruption
  • Placental abnormalities for example previa, accreta

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): NCT03246919


Locations
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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
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Principal Investigator: Thaddeus Waters, MD Loyola University
Publications:
National Collaborating Centre for Women's and Children's Health. Caesarean section NICE Clinical Guideline. Royal College of Obstetricians and Gynaecologists
Silverman, F. & Bornstein, E. Pharmacologic management of the third stage of labor. UpToDate. 2015

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Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT03246919    
Other Study ID Numbers: 209632
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
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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Postpartum Hemorrhage
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Intraoperative Complications
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs