Placental Transfusion in Term Infants: A Pilot Study

Placental Transfusion in Term Infants Placed Skin-to-Skin: A Pilot Controlled Trial

The proposed study is a pilot prospective controlled trial to measure the blood volume left in the placenta after varying cord clamping times when the infant is placed skin-to-skin on the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants. However, the best way to get the most blood to the baby is not known. The practice of cord clamping at birth is not the same among doctors and midwives and we do not know the effect of putting he baby on the mother's abdomen.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Procedure: cord clamping at 2 minutes; Procedure: cord clamping at 5 minutes; Procedure: cord milking

Detailed Description

The proposed study is a pilot prospective controlled trial to measure the placental residual blood volume after varying cord clamping protocols when the infants are placed skin-to-skin on the maternal abdomen. The study assessed compliance of the providers with the different protocols. Placental transfusion (PT) has been shown to increase infant body iron stores at 6 months of age without increasing adverse outcomes. However, the optimal protocol to achieve adequate placental transfusion is not known. The practice of cord clamping at birth is not uniform among obstetrical providers because adequate evidence to support early or late cord clamping has been lacking.

Women were eligible to enroll in the study if they had no pregnancy complications, did not smoke, planned to breastfeed, and planned to deliver vaginally between 37 and 416/7 weeks. Women were enrolled prenatally on the labor and delivery unit. At birth, women were assigned to one of four cord clamping/milking groups. A cohort of infants with immediate cord clamping serves as reference group. Infants had blood samples drawn with the routine newborn screening blood samples done at 36 to 48 hours. Information on infant health and feeding was completed through an in-hospital visit to the mother and by home visit at two weeks of age. The primary outcome measures were placental residual blood volume and compliance with the various assigned cord clamping protocols. It was expected that infants with delayed cord clamping or cord milking would have less placental residual blood volume and that most providers would comply with the various random assignments.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria: Women with normal pregnancy and presented at the labor room at 38-416/7 weeks for vaginal delivery; Intention to breast feed the babies; Consent for a follow up at 2 weeks of age

Exclusion Criteria: Abnormal pregnancy: Gestational or pre-existing diabetes, smoking and substance abuse, pre-eclampsia, fetal abnormality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Immediate cord clamping; provider clamps and cuts the cord within 10 seconds after birth
Experimental: cord clamping at 2 minutes; Provider places infant on maternal abdomen and cuts cord at 2 minutes after birth	Procedure: cord clamping at 2 minutes
Experimental: cord clamping at 5 minutes; Provider places the infant on maternal abdomen and clamps and cuts cord at 5 minutes	Procedure: cord clamping at 5 minutes
Experimental: cord milking; provider milks the cord 5 times from placenta to infant	Procedure: cord milking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placental Residual Blood volume	Blood remaining in the placenta after cord clamping measured by drainage	obtained immediately after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant hematocrit and hemoglobin	Capillary hematocrit and hemoglobin drawn when the genetic samples were drawn	at 36 to 48 hours of age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum bilirubin	serum bilirubin drawn when the infant's genetic screen was drawn	at 36 to 48 hours of age

Collaborators and Investigators

• Sponsor: University of Rhode Island
• Investigators: Principal Investigator: Judith S Mercer, PhD, CNM, University of Rhode Island; Study Director: Debra A Erickson-owens, PhD, CNM, University of Rhode Island

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 14, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Estimate): August 16, 2013
• Last Update Submitted That Met QC Criteria: August 14, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: hemoglobin; umbilical cord clamping; bilirubin; hematocrit; Placental residual blood volume
• Other Study ID Numbers: Term Pilot Study