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NCT04353544 Clinical Trial

Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery

Post Partum Hemorrhage Clinical Trial

Official title:
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04353544
Other study ID # 1/04-18OST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 16, 2020
Est. completion date May 1, 2021

Study information
Verified date August 2021
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date May 1, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - singleton pregnancy - at term - cephalic presentation - spontaneous labor - spontaneous vaginal delivery Exclusion Criteria: - multiple gestation - preterm gestation - induced labor - operative delivery - hypertension or preeclampsia - fetal anomaly - abnormal placentation - planned cord blood banking - maternal bleeding disorder

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• delayed cord clamping
delayed cord clamping

Locations
Country Name City State
Italy Casa di Cura Accreditata Fabia Mater, Rome, Italy Rome Roma

Sponsors (2)
Lead Sponsor Collaborator
Federico II University Casa di Cura Accreditata Fabia Mater, Rome, Italy

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level The primary outcome was an objective measure of maternal blood loss: the change in maternal hemoglobin level on postdelivery day 1 compared with the predelivery hemoglobin level. day 1 after delivery
Secondary postpartum hemorrhage defined as estimated blood loss>500cc at the time of delivery
Secondary uterotonic administration at the time of delivery
Secondary need for blood transfusion at the time of delivery
Secondary jaundice neonatal jaundice day 10 of life
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