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

August 21, 2021 updated by: Gabriele Saccone, Federico II University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Roma
      • Rome, Roma, Italy, 80129
        • Casa di Cura Accreditata Fabia Mater, Rome, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate cord clamping
Immediate cord clamping was defined as clampingwithin 15 seconds of birth
Other: delayed cord clamping
delayed cord clamping
Experimental: delayed cord clamping
when the cord stopped pulsing, or five minutes
Other: delayed cord clamping
delayed cord clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level
Time Frame: day 1 after delivery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
postpartum hemorrhage
Time Frame: at the time of delivery
defined as estimated blood loss>500cc
at the time of delivery
uterotonic administration
Time Frame: at the time of delivery
at the time of delivery
need for blood transfusion
Time Frame: at the time of delivery
at the time of delivery
jaundice
Time Frame: day 10 of life
neonatal jaundice
day 10 of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Collaborators

Casa di Cura Accreditata Fabia Mater, Rome, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2020

Primary Completion (Actual)

February 25, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 21, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/04-18OST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

not planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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