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

Primary Purpose

Blood Loss, Surgical, Postpartum Hemorrhage, Bleed Pregnancy

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss, Surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control (Group A)

Intervention (Group B)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total blood loss
Both the estimated blood loss and quantitative blood loss will be determined

Secondary Outcome Measures

Incidence of postpartum hemorrhage
The number of women who lose 1,000 milliliters or more blood from cesarean delivery
Need for transfusion
The number of women who require a blood transfusion due to surgical blood loss
Change in pre-operative to post-operative hemoglobin levels
Hemoglobin levels

Full Information

First Posted
August 4, 2017
Last Updated
June 16, 2020
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT03246919
Brief Title
Ideal Time of Oxytocin Infusion During Cesarean Section
Acronym
I-TOPICS
Official Title
Ideal Time of Oxytocin Infusion During Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
PI left Loyola and Sub-I graduated.
Study Start Date
September 13, 2017 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
February 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loyola University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Postpartum Hemorrhage, Bleed Pregnancy, Pregnancy Related, Cesarean Section Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double blind: Obstetricians, Anesthesiologists and patients will be blinded. Only nurses will be aware of timing of oxytocin administration
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (Group A)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Intervention (Group B)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered after delivery of the placenta
Primary Outcome Measure Information:
Title
Total blood loss
Description
Both the estimated blood loss and quantitative blood loss will be determined
Time Frame
At the completion of the surgery when patient is transferred to recovery from the operating room
Secondary Outcome Measure Information:
Title
Incidence of postpartum hemorrhage
Description
The number of women who lose 1,000 milliliters or more blood from cesarean delivery
Time Frame
At the completion of the surgery when patient is transferred to recovery from the operating room
Title
Need for transfusion
Description
The number of women who require a blood transfusion due to surgical blood loss
Time Frame
In the immediate 24 hours post surgery
Title
Change in pre-operative to post-operative hemoglobin levels
Description
Hemoglobin levels
Time Frame
Baseline and Post operative day number 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thaddeus Waters, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11641669
Citation
Jackson KW Jr, Allbert JR, Schemmer GK, Elliot M, Humphrey A, Taylor J. A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum hemorrhage. Am J Obstet Gynecol. 2001 Oct;185(4):873-7. doi: 10.1067/mob.2001.117363.
Results Reference
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PubMed Identifier
20687079
Citation
Soltani H, Hutchon DR, Poulose TA. Timing of prophylactic uterotonics for the third stage of labour after vaginal birth. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD006173. doi: 10.1002/14651858.CD006173.pub2.
Results Reference
background
PubMed Identifier
24897394
Citation
Fidan U, Keskin U, Ulubay M, Efendi Karaca R, Burcin Firatligil F, Goksen Kocagoz G, Ergun A. The effect of the use of oxytocin on blood loss during different postpartum periods. J Perinat Med. 2015 Jul;43(4):461-5. doi: 10.1515/jpm-2014-0111.
Results Reference
background
PubMed Identifier
25108586
Citation
Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.
Results Reference
background
PubMed Identifier
23467047
Citation
Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.
Results Reference
background
PubMed Identifier
17312645
Citation
Khan FA, Khan M, Ali A, Chohan U. Estimation of blood loss during Caesarean section: an audit. J Pak Med Assoc. 2006 Dec;56(12):572-5.
Results Reference
background
PubMed Identifier
17390600
Citation
Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.
Results Reference
background
PubMed Identifier
23586122
Citation
WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/
Results Reference
background
Citation
National Collaborating Centre for Women's and Children's Health. Caesarean section NICE Clinical Guideline. Royal College of Obstetricians and Gynaecologists
Results Reference
background
Citation
Silverman, F. & Bornstein, E. Pharmacologic management of the third stage of labor. UpToDate. 2015
Results Reference
background

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Ideal Time of Oxytocin Infusion During Cesarean Section

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