Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants

Uppsala University

Status: Completed

Conditions: Neonatal Hyperbilirubinemia; Iron Deficiency

Treatments: Procedure: Timing of clamping the umbilical cord

Study type: Interventional

Funder types: Other

Identifiers

NCT01245296

NATIBAR08

Details and patient eligibility

About

Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared with early clamping, a delay of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight.

The results of previous intervention studies on delayed clamping are mixed, and few followed up infants beyond the perinatal period. All longer follow up studies have been performed in low income countries. The main objectives, therefore, was to assess whether delayed cord clamping improves hematological and iron status at 4 respective 12 months of age in a large sample of full-term, Swedish infants.

The investigators also choose to investigate if the timing of clamping the umbilical cord could affect rate of infections during the first four months of life and to assess the infants development at 4 and 12 months of age.

Enrollment: 392 patients

Sex: All

Ages: 37 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• non-smoking mother
• healthy mother (no hemolytic disease, no treatment with any of the following drugs: anticonvulsants, antidepressants, thyroid hormone, insulin, chemotherapy or cortisone),
• normal pregnancy (no preeclampsia, no diabetes, no prolonged rupture of membranes or signs of infection)
• single birth, term pregnancy (gestational age 37 +0 until 41 +6 weeks + days)
• expected vaginal delivery with cephalic presentation
• mother should be able to master Swedish well enough to participate in the study
• mother should live close enough to the hospital to be ready to return for follow up after four months.

Exclusion criteria

• Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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392 participants in 2 patient groups

Early cord clamping (ECC)

Other group

Description:

Early cord clamping consisted of early (\< 10 s) clamping of the umbilical cord and obtaining blood gas samples after clamping.

Treatment:

Procedure: Timing of clamping the umbilical cord

Delayed cord clamping (DCC)

Other group

Description:

Delayed cord clamping consisted of delayed (\> 180 s) clamping of the umbilical cord and obtaining blood gas samples before clamping (within 30 seconds).

Treatment:

Procedure: Timing of clamping the umbilical cord