Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

NCT04632264 | Completed

• 1 other identifier: AAAS9154
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cumulative Maternal Adverse Outcomes

  Postpartum, Up to 6 weeks

• Cumulative Neonatal Adverse Outcomes

  Post Delivery, Up to 6 weeks

Study Arms (2)

Pre-placental group

EXPERIMENTAL

Oxytocin will be initiated immediately after delivery of the neonatal anterior shoulder (within 15 seconds). This is our "intervention" group. Saline placebo will be initiated post placenta delivery (within 15 seconds).

Other: Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery; Other: Saline Placebo

Post-placental group

OTHER

Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds). Oxytocin will be initiated immediately after placenta delivery (within 15 seconds).

Other: Initiation of standard postpartum oxytocin immediately following placenta delivery; Other: Saline Placebo

Interventions

Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery OTHER

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

Pre-placental group

Initiation of standard postpartum oxytocin immediately following placenta delivery OTHER

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

Post-placental group

Saline Placebo OTHER

Saline placebo will be initiated post placenta delivery (within 15 seconds).

Pre-placental group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (10)

• 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;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.

  PMID: 23843134 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

• 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.

  PMID: 27733286 BACKGROUND

• Rana N, Kc A, Malqvist 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.

  PMID: 30278462 BACKGROUND

• Andersson O, Lindquist B, Lindgren M, Stjernqvist K, Domellof M, Hellstrom-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.

  PMID: 26010418 BACKGROUND

• Andersson O, Hellstrom-Westas L, Andersson D, Domellof 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.

  PMID: 22089242 BACKGROUND

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

  PMID: 28002310 BACKGROUND

• 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.

  PMID: 31742629 BACKGROUND

• 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.

  PMID: 27732984 BACKGROUND

• 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

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephanie E. Purish, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomization will be achieved using a computer generated algorithm. Both patient and provider will be unaware of the allocation arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel randomized, placebo-controlled, and double-blinded studies. For this study we will include 52 scheduled cesarean sections and 52 vaginal deliveries as two separate cohorts.

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 17, 2020
• Study Start: December 10, 2020
• Primary Completion: April 2, 2021
• Study Completion: September 16, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)