Placental Transfusion in Term Infants: A Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anemia

Intervention / Treatment
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* Procedure: cord clamping at 2 minutes
* Procedure: cord clamping at 5 minutes
* Procedure: cord milking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematocrit, umbilical cord clamping, Placental residual blood volume, hemoglobin, bilirubin