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OpenTrials
Completed

NCT Number: NCT04353544

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

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

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Key information

Conditions

Post Partum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Casa di Cura Accreditata Fabia Mater, Rome, Italy

Rome, Roma, 80129, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delayed cord clamping

Other

delayed cord clamping

Primary outcomes

  1. 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.

Secondary outcomes

  1. postpartum hemorrhage

    Time frame: at the time of delivery

    defined as estimated blood loss>500cc

  2. uterotonic administration

    Time frame: at the time of delivery

  3. need for blood transfusion

    Time frame: at the time of delivery

  4. jaundice

    Time frame: day 10 of life

    neonatal jaundice

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • Casa di Cura Accreditata Fabia Mater, Rome, Italy

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2020
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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