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

• Sponsor: Federico II University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04353544
• Collaborator: Casa di Cura Accreditata Fabia Mater, Rome, Italy (Other)
• Enrollment: 122
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.5
• Patients Per Site Per Month: 9.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Post Partum Hemorrhage	Other: delayed cord clamping	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery
• Actual Study Start Date: Apr 16, 2020
• Actual Primary Completion Date: Feb 25, 2021
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level [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 Outcome Measures

1. postpartum hemorrhage [at the time of delivery]

   defined as estimated blood loss>500cc

2. uterotonic administration [at the time of delivery]

3. need for blood transfusion [at the time of delivery]

4. jaundice [day 10 of life]

   neonatal jaundice

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Casa di Cura Accreditata Fabia Mater, Rome, Italy	Rome	Roma	Italy	80129

Sponsors and Collaborators

• Federico II University
• Casa di Cura Accreditata Fabia Mater, Rome, Italy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gabriele Saccone, principal investigator, medical doctor, Federico II University
• ClinicalTrials.gov Identifier: NCT04353544
• Other Study ID Numbers: 1/04-18OST
• First Posted: Apr 20, 2020
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Postpartum Hemorrhage; Hemorrhage

Study Results

No Results Posted as of Aug 24, 2021