Clinical trial NCT01924572: Placental Transfusion in Term Infants: A Pilot Study
Official title: Placental Transfusion in Term Infants Placed Skin-to-Skin: A Pilot Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: umbilical cord clamping
Placental residual blood volume
hematocrit
hemoglobin
bilirubin
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Placental Residual Blood volume
timeFrame: obtained immediately after birth
Secondary outcomes:
measure: Infant hematocrit and hemoglobin
timeFrame: at 36 to 48 hours of age
Other outcomes:
measure: serum bilirubin
timeFrame: at 36 to 48 hours of age
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
affiliation: University of Rhode Island
name: Judith S Mercer, PhD, CNM
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rhode Island
name: Debra A Erickson-owens, PhD, CNM
role: STUDY_DIRECTOR
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