Back to resultsEffect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery
Primary Purpose
Post Partum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
delayed cord clamping
Sponsored by
About this trial
This is an interventional prevention trial for Post Partum Hemorrhage
Eligibility Criteria
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
Sites / Locations
- Casa di Cura Accreditata Fabia Mater, Rome, Italy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Immediate cord clamping
delayed cord clamping
Arm Description
Immediate cord clamping was defined as clampingwithin 15 seconds of birth
when the cord stopped pulsing, or five minutes
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
postpartum hemorrhage
defined as estimated blood loss>500cc
uterotonic administration
need for blood transfusion
jaundice
neonatal jaundice
Full Information
NCT ID
NCT04353544
First Posted
April 16, 2020
Last Updated
August 21, 2021
Sponsor
Federico II University
Collaborators
Casa di Cura Accreditata Fabia Mater, Rome, Italy
1. Study Identification
Unique Protocol Identification Number
NCT04353544
Brief Title
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery
Official Title
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
Collaborators
Casa di Cura Accreditata Fabia Mater, Rome, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate cord clamping
Arm Type
Active Comparator
Arm Description
Immediate cord clamping was defined as clampingwithin 15 seconds of birth
Arm Title
delayed cord clamping
Arm Type
Experimental
Arm Description
when the cord stopped pulsing, or five minutes
Intervention Type
Other
Intervention Name(s)
delayed cord clamping
Intervention Description
delayed cord clamping
Primary Outcome Measure Information:
Title
change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level
Description
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.
Time Frame
day 1 after delivery
Secondary Outcome Measure Information:
Title
postpartum hemorrhage
Description
defined as estimated blood loss>500cc
Time Frame
at the time of delivery
Title
uterotonic administration
Time Frame
at the time of delivery
Title
need for blood transfusion
Time Frame
at the time of delivery
Title
jaundice
Description
neonatal jaundice
Time Frame
day 10 of life
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Casa di Cura Accreditata Fabia Mater, Rome, Italy
City
Rome
State/Province
Roma
ZIP/Postal Code
80129
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
not planned
Citations:
PubMed Identifier
35428979
Citation
De Angelis C, Saccone G, Sorichetti E, Alagna M, Zizolfi B, Gragnano E, Legnante A, Sardo ADS. Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial. Int J Gynaecol Obstet. 2022 Dec;159(3):898-902. doi: 10.1002/ijgo.14223. Epub 2022 May 2.
Results Reference
derived
Learn more about this trial
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery
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