Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

Postpartum Hemorrhage Clinical Trial

— PROCEEDING  

Official title:

Optimal Timing of Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping - PROCEEDING (PostpaRtum OxytoCin Era dElayed corD clampING) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632264
• Other study ID #: AAAS9154
• Status: Completed
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: September 16, 2021

Study information

• Verified date: December 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Increased blood loss after vaginal or cesarean delivery is one of the top causes of maternal complications. Oxytocin is a common medication given to mothers by IV or an injection to limit the amount of blood loss after delivery. The investigators do not know the best time after delivery that oxytocin should be given. This research is being done to find out if starting the medication oxytocin right after the baby is born or after the placenta comes out decreases the amount of blood lost after birth when we delay cord clamping after birth.

Description:

The optimal timing of prophylactic oxytocin administration on both maternal and neonatal outcomes has not been definitively established with delayed cord clamping. Maternal considerations include the risk of postpartum hemorrhage, need for additional uterotonic medications, need for maternal transfusion, retained placenta, and postpartum drop in hemoglobin. Neonatal considerations include markers of neonatal well-being such as arterial pH and 5-minute Apgar score, as well as hemoglobin and bilirubin levels. There is currently no protocol on the timing of third stage prophylactic oxytocin and its administration is based on physician/ delivery provider's preference. The investigators propose a quality assessment initiative, through a randomized controlled trial designed to compare the blood loss between administrations of prophylactic oxytocin immediately after delivery of the neonate versus after delivery of the placenta with delayed cord clamping.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 16, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All laboring women (induced, augmented, or spontaneous) at term admitted to Labor and Delivery while comfortable

• Scheduled cesareans

• Women aged 18 years or older

• Admitted at NewYork-Presbyterian Morgan Stanley Children's Hospital (CHONY) or Allen Pavilion Labor and Delivery units

Exclusion Criteria:

• Multifetal gestation

• Placental abruption or antepartum hemorrhage

• Maternal bleeding disorder

• Known fetal anomaly or anemia

• Fetal growth restriction with abnormal Doppler

• Significant maternal anemia (pre-operative hemoglobin = 7g/dL

• Intrapartum stillbirth

• Placenta accreta spectrum

• Abnormal placentation (previa or abruption)

• Planned cord blood banking

• Refusal of blood products

• Any contraindication for delayed cord clamping

• Maternal history of aortic stenosis or pulmonary hypertension or other severe cardiac structural disease

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Other:
• Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery
The intervention is to determine if initiating oxytocin as soon as the fetus is delivered decreased postpartum blood loss. 30 units in 500 milliliters of 0.9% sodium chloride
• Initiation of standard postpartum oxytocin immediately following placenta delivery
Standard of care includes oxytocin administration post-delivery regardless of delivery mode. This is the comparative group. 30 units in 500 milliliters of 0.9% sodium chloride
• Saline Placebo
Saline placebo will be initiated post placenta delivery (within 15 seconds).
• Saline Placebo
Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds).

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Andersson O, Hellström-Westas L, Andersson D, Domellöf M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ. 2011 Nov 15;343:d7157. doi: 10.1136/bmj.d7157. — View Citation

Andersson O, Lindquist B, Lindgren M, Stjernqvist K, Domellöf M, Hellström-Westas L. Effect of Delayed Cord Clamping on Neurodevelopment at 4 Years of Age: A Randomized Clinical Trial. JAMA Pediatr. 2015 Jul;169(7):631-8. doi: 10.1001/jamapediatrics.2015.0358. — View Citation

Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860. — View Citation

GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1775-1812. doi: 10.1016/S0140-6736(16)31470-2. Erratum in: Lancet. 2017 Jan 7;389(10064):e1. — View Citation

Hamm RF, Wang EY, Bastek JA, Srinivas SK. Assessing reVITALize: Should the Definition of Postpartum Hemorrhage Differ by Mode of Delivery? Am J Perinatol. 2017 Apr;34(5):503-507. doi: 10.1055/s-0036-1593535. Epub 2016 Oct 12. — 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

McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;(7):CD004074. doi: 10.1002/14651858.CD004074.pub3. Review. — View Citation

Purisch SE, Ananth CV, Arditi B, Mauney L, Ajemian B, Heiderich A, Leone T, Gyamfi-Bannerman C. Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1869-1876. doi: 10.1001/jama.2019.15995. — View Citation

Rana N, Kc A, Målqvist M, Subedi K, Andersson O. Effect of Delayed Cord Clamping of Term Babies on Neurodevelopment at 12 Months: A Randomized Controlled Trial. Neonatology. 2019;115(1):36-42. doi: 10.1159/000491994. Epub 2018 Oct 2. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin	Change defined as greater or equal to 1.0 g/dL (= 1 standard deviation (SD)) hemoglobin drop between the two arms following a vaginal delivery and greater or equal to 0.9 g/dL (= 1SD) following a cesarean delivery.	Up to 24 hours
Secondary	Cumulative Maternal Adverse Outcomes	Any adverse maternal outcome (adverse event) including blood transfusion or symptomatic anemia.	Postpartum, Up to 6 weeks
Secondary	Cumulative Neonatal Adverse Outcomes	Any adverse neonatal outcome (adverse event) including jaundice, hematocrit laboratory abnormality.	Post Delivery, Up to 6 weeks