Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

Mansoura University Children Hospital

Status: Completed

Conditions: Preterm Infant; Placental Transfusion; Placental Insufficiency

Treatments: Procedure: Delayed cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT03731546

MS/17.04.15

Details and patient eligibility

About

To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental insufficiency underwent DDC could have better hematologic parameters and hematopoietic progenitor cells compared to immediate cord clamping.

Full description

• A prospective randomized controlled study will be performed on preterm infants 34 weeks gestational age or less with placental insufficiency, and those without placental insufficiency where DCC will be performed in both groups. A third group of preterm with placental insufficiency and immediate cord clamping will be performed as a control.

Enrollment: 90 patients

Sex: All

Ages: Under 1 minute old

Volunteers: No Healthy Volunteers

Inclusion criteria

• preterm neonates < 34 weeks gestational age

Exclusion criteria

• Vaginal bleeding due to placental abruption or tears Multiple pregnancies Suspected major fetal anomalies Suspected chromosomal aberration Maternal drug abuse Hydrops fetalis preterm who needed major resuscitative measures

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Group A

No Intervention group

Description:

Placental insufficiency and ICC : Immediate cord clamping after delivery of the fetus in preterm infants with placental insufficiency

Group B

Active Comparator group

Description:

Placental insufficiency and DCC: Cord clamping 60 seconds after delivery of fetus in preterm infants with placental insufficiency

Treatment:

Procedure: Delayed cord clamping

Group C

Active Comparator group

Description:

Normal placenta with DCC:Cord clamping 60 seconds after delivery of fetus in preterm infants without placental insufficiency

Treatment:

Procedure: Delayed cord clamping