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Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery

NCT02411916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2021-09-30

Study results available
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Summary

This document defines the Clinical Investigation Protocol for a study designed to determine whether blood loss after spontaneous vaginal delivery is altered by the addition of misoprostol administration to the standard use of intravenous oxytocin after delivery. The protocol is an open-label randomized prospective trial to be carried out at Queens Hospital Center.

Blood loss will be measured indirectly by comparing the maternal hemoglobin and hematocrit levels on admission in labor to those obtained within 24 hours after delivery.

Conditions

  • Postpartum Hemorrhage

Interventions

BIOLOGICAL

misoprostol

rectal insertion

Sponsors & Collaborators

  • New York City Health and Hospitals Corporation

    lead OTHER

Principal Investigators

  • Aleksandr Fuks, MD · Queens Hopsital Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-30
Primary Completion
2019-02-16
Completion
2019-02-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02411916 on ClinicalTrials.gov