CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 104 enrolled
Drug / intervention
Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04632264
NCT04632264N/ACompleted

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

Columbia University·interventional·Posted Nov 17, 2020·Updated Dec 29, 2021

In Brief

A clinical study evaluating Initiation of standard postpartum oxytocin immediately following fetal shoulder delivery, Initiation of standard postpartum oxytocin immediately following placenta delivery, and 1 other intervention for Postpartum Hemorrhage. Completed, enrolled 104 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 17, 2020
Enrollment StartDec 10, 2020
Primary CompletionApr 2, 2021
Study CompletionSep 16, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.6 years ago

Interventions

Initiation of standard postpartum oxytocin immediately following fetal shoulder deliveryother

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 deliveryother

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 Placeboother

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

Saline Placeboother

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