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Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

NCT ID: NCT04632264

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2021-09-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
Randomization will be achieved using a computer generated algorithm. Both patient and provider will be unaware of the allocation arm.

Study Groups

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Pre-placental group

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).

Group Type EXPERIMENTAL

Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery

Intervention Type 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

Saline Placebo

Intervention Type OTHER

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

Post-placental group

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

Group Type OTHER

Initiation of standard postpartum oxytocin immediately following placenta delivery

Intervention Type 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

Saline Placebo

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Saline Placebo

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

Intervention Type OTHER

Saline Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie E. Purish, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23843134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20687079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27733286 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30278462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26010418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22089242 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 28002310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31742629 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27732984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11641669 (View on PubMed)

Other Identifiers

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AAAS9154

Identifier Type: -

Identifier Source: org_study_id