Ideal Time of Oxytocin Infusion During Cesarean Section
NCT ID: NCT03246919
Last Updated: 2020-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
68 participants
INTERVENTIONAL
2017-09-13
2020-02-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Placebo will be administered after delivery of the placenta
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
Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
Interventions
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Oxytocin
Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
Placebo
Placebo will be administered after delivery of the placenta
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women who read and speak the English and/or Spanish language
* Women age 18 or older
Exclusion Criteria
* Gestation under 37 weeks and 0 days
* Women with coagulopathies
* Multiple gestation pregnancies
* Antepartum hemorrhage for example abruption
* Placental abnormalities for example previa, accreta
18 Years
FEMALE
Yes
Sponsors
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Loyola University
OTHER
Responsible Party
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Principal Investigators
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Thaddeus Waters, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Locations
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Loyola University Medical Center
Maywood, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.
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/
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
Other Identifiers
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209632
Identifier Type: -
Identifier Source: org_study_id
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