Clinical trial NCT04632264: Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping
Official title: Optimal Timing of Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping - PROCEEDING (PostpaRtum OxytoCin Era dElayed corD clampING) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hemoglobin
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Cumulative Maternal Adverse Outcomes
timeFrame: Postpartum, Up to 6 weeks
measure: Cumulative Neonatal Adverse Outcomes
timeFrame: Post Delivery, Up to 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Stephanie E. Purish, MD
role: PRINCIPAL_INVESTIGATOR
References:
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;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
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: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.
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.
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.
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.