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

Not Applicable
Completed
Conditions
Post Partum Hemorrhage
Interventions
Other: delayed cord clamping
Registration Number
NCT04353544
Lead Sponsor
Federico II University
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
122
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Immediate cord clampingdelayed cord clampingImmediate cord clamping was defined as clampingwithin 15 seconds of birth
delayed cord clampingdelayed cord clampingwhen the cord stopped pulsing, or five minutes
Primary Outcome Measures
NameTimeMethod
change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin levelday 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.

Secondary Outcome Measures
NameTimeMethod
uterotonic administrationat the time of delivery
jaundiceday 10 of life

neonatal jaundice

need for blood transfusionat the time of delivery
postpartum hemorrhageat the time of delivery

defined as estimated blood loss\>500cc

Trial Locations

Locations (1)

Casa di Cura Accreditata Fabia Mater, Rome, Italy

🇮🇹

Rome, Roma, Italy

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