Ideal Time of Oxytocin Infusion During Cesarean Section

Pregnancy Related Clinical Trial

— I-TOPICS  

Official title:

Ideal Time of Oxytocin Infusion During Cesarean Section

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03246919
• Other study ID #: 209632
• Status: Terminated
• Phase: Phase 4
• Start date: September 13, 2017
• Est. completion date: February 24, 2020

Study information

• Verified date: August 2019
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: February 24, 2020
• Est. primary completion date: February 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleed Pregnancy
• Blood Loss, Surgical
• Cesarean Section Complications
• Hemorrhage
• Postpartum Hemorrhage
• Pregnancy Related

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82. — View 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. Review. — View Citation

Fidan U, Keskin U, Ulubay M, Efendi Karaca R, Burçin Firatligil F, Göksen Kocagöz G, Ergün 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. — View 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. — View 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. — View Citation

National Collaborating Centre for Women's and Children's Health. Caesarean section NICE Clinical Guideline. Royal College of Obstetricians and Gynaecologists

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. — View Citation

Silverman, F. & Bornstein, E. Pharmacologic management of the third stage of labor. UpToDate. 2015

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. Review. — View Citation

WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total blood loss	Both the estimated blood loss and quantitative blood loss will be determined	At the completion of the surgery when patient is transferred to recovery from the operating room
Secondary	Incidence of postpartum hemorrhage	The number of women who lose 1,000 milliliters or more blood from cesarean delivery	At the completion of the surgery when patient is transferred to recovery from the operating room
Secondary	Need for transfusion	The number of women who require a blood transfusion due to surgical blood loss	In the immediate 24 hours post surgery
Secondary	Change in pre-operative to post-operative hemoglobin levels	Hemoglobin levels	Baseline and Post operative day number 1