Clinical trial NCT03246919: Ideal Time of Oxytocin Infusion During Cesarean Section
Official title: Ideal Time of Oxytocin Infusion During Cesarean Section
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Blood Loss, Surgical
Postpartum Hemorrhage
Bleed Pregnancy
Pregnancy Related
Cesarean Section Complications
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total blood loss
timeFrame: At the completion of the surgery when patient is transferred to recovery from the operating room
Secondary outcomes:
measure: Incidence of postpartum hemorrhage
timeFrame: At the completion of the surgery when patient is transferred to recovery from the operating room
measure: Need for transfusion
timeFrame: In the immediate 24 hours post surgery
measure: Change in pre-operative to post-operative hemoglobin levels
timeFrame: Baseline and Post operative day number 1
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Thaddeus Waters, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.
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/
citation: National Collaborating Centre for Women's and Children's Health. Caesarean section NICE Clinical Guideline. Royal College of Obstetricians and Gynaecologists
citation: Silverman, F. & Bornstein, E. Pharmacologic management of the third stage of labor. UpToDate. 2015