Ideal Time of Oxytocin Infusion During Cesarean Section

NCT03246919 | Terminated Phase 4 FDA Drug

• 1 other identifier: 209632
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of postpartum hemorrhage

  At the completion of the surgery when patient is transferred to recovery from the operating room

• Need for transfusion

  In the immediate 24 hours post surgery

• Change in pre-operative to post-operative hemoglobin levels

  Baseline and Post operative day number 1

Study Arms (2)

Control (Group A)

PLACEBO COMPARATOR

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.

Drug: Placebo

Intervention (Group B)

ACTIVE COMPARATOR

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.

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta

Also known as: Pitocin

Intervention (Group B)

Placebo DRUG

Placebo will be administered after delivery of the placenta

Control (Group A)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing cesarean section at Loyola Hospital
• Women who read and speak the English and/or Spanish language
• Women age 18 or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (10)

• 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.

  PMID: 11641669 BACKGROUND

• 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.

  PMID: 20687079 BACKGROUND

• 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.

  PMID: 24897394 BACKGROUND

• 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.

  PMID: 25108586 BACKGROUND

• 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.

  PMID: 23467047 BACKGROUND

• 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.

  PMID: 17312645 BACKGROUND

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

  PMID: 17390600 BACKGROUND

• 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/

  PMID: 23586122 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical; Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Thaddeus Waters, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind: Obstetricians, Anesthesiologists and patients will be blinded. Only nurses will be aware of timing of oxytocin administration
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 11, 2017
• Study Start: September 13, 2017
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: June 18, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)