ClinicalTrials.Veeva

Menu

Placental Transfusion in Term Infants: A Pilot Study

U

University of Rhode Island

Status

Completed

Conditions

Anemia

Treatments

Procedure: cord clamping at 2 minutes
Procedure: cord milking
Procedure: cord clamping at 5 minutes

Study type

Interventional

Funder types

Other

Identifiers

NCT01924572
Term Pilot Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

32 participants in 4 patient groups

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems