Ideal Time of Oxytocin Infusion During Cesarean Section (I-TOPICS)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Blood Loss, Surgical Postpartum Hemorrhage Bleed Pregnancy Pregnancy Related Cesarean Section Complications||Drug: Oxytocin Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|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|
|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|
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.
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.
Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
Other Name: Pitocin
- 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
- 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
- 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
- Change in pre-operative to post-operative hemoglobin levels [ Time Frame: Baseline and Post operative day number 1 ]Hemoglobin levels
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
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Thaddeus Waters, MD||Loyola University|