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PROCEEDING: Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT04632264
Collaborator
(none)
104
Enrollment
1
Location
2
Arms
9.2
Actual Duration (Months)
11.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery
  • Other: Initiation of standard postpartum oxytocin immediately following placenta delivery
  • Other: Saline Placebo
  • Other: Saline Placebo
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Double (Participant, Care Provider)
Masking Description:
Randomization will be achieved using a computer generated algorithm. Both patient and provider will be unaware of the allocation arm.
Primary Purpose:
Prevention
Official Title:
Optimal Timing of Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping - PROCEEDING (PostpaRtum OxytoCin Era dElayed corD clampING) Study
Actual Study Start Date :
Dec 10, 2020
Actual Primary Completion Date :
Apr 2, 2021
Actual Study Completion Date :
Sep 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in Hemoglobin [Up to 24 hours]

    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.

Secondary Outcome Measures

  1. Cumulative Maternal Adverse Outcomes [Postpartum, Up to 6 weeks]

    Any adverse maternal outcome (adverse event) including blood transfusion or symptomatic anemia.

  2. Cumulative Neonatal Adverse Outcomes [Post Delivery, Up to 6 weeks]

    Any adverse neonatal outcome (adverse event) including jaundice, hematocrit laboratory abnormality.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Irving Medical Center New York New York United States 10032

Sponsors and Collaborators

  • Columbia University

Investigators

  • Principal Investigator: Stephanie E. Purish, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Columbia University
ClinicalTrials.gov Identifier:
NCT04632264
Other Study ID Numbers:
  • AAAS9154
First Posted:
Nov 17, 2020
Last Update Posted:
Dec 29, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Postpartum Hemorrhage
Hemorrhage
Oxytocin

Study Results

No Results Posted as of Dec 29, 2021