Skip to main content
OpenTrials
Completed

NCT Number: NCT01924572

Placental Transfusion in Term Infants: A Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

cord clamping at 2 minutes

Procedure

cord clamping at 5 minutes

Procedure

Cord Milking

Procedure

Primary outcomes

  1. Placental Residual Blood volume

    Time frame: obtained immediately after birth

    Blood remaining in the placenta after cord clamping measured by drainage

Secondary outcomes

  1. Infant hematocrit and hemoglobin

    Time frame: at 36 to 48 hours of age

    Capillary hematocrit and hemoglobin drawn when the genetic samples were drawn

Other outcomes

  1. serum bilirubin

    Time frame: at 36 to 48 hours of age

    serum bilirubin drawn when the infant's genetic screen was drawn

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 16, 2013
Registry last updated
Aug 16, 2013

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.

Published trials that share one or more normalized conditions with this study.