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Placental Transfusion in Term Infants: A Pilot Study

NCT ID: NCT01924572

Last Updated: 2013-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-05-31

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.

Conditions

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Anemia

Keywords

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umbilical cord clamping Placental residual blood volume hematocrit hemoglobin bilirubin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate cord clamping

provider clamps and cuts the cord within 10 seconds after birth

Group Type NO_INTERVENTION

No interventions assigned to this group

cord clamping at 2 minutes

Provider places infant on maternal abdomen and cuts cord at 2 minutes after birth

Group Type EXPERIMENTAL

cord clamping at 2 minutes

Intervention Type PROCEDURE

cord clamping at 5 minutes

Provider places the infant on maternal abdomen and clamps and cuts cord at 5 minutes

Group Type EXPERIMENTAL

cord clamping at 5 minutes

Intervention Type PROCEDURE

cord milking

provider milks the cord 5 times from placenta to infant

Group Type EXPERIMENTAL

cord milking

Intervention Type PROCEDURE

Interventions

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cord clamping at 2 minutes

Intervention Type PROCEDURE

cord clamping at 5 minutes

Intervention Type PROCEDURE

cord milking

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Judith S Mercer

Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith S Mercer, PhD, CNM

Role: PRINCIPAL_INVESTIGATOR

University of Rhode Island

Debra A Erickson-owens, PhD, CNM

Role: STUDY_DIRECTOR

University of Rhode Island

Locations

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Women & Infants Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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Term Pilot Study

Identifier Type: -

Identifier Source: org_study_id