Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-03-01

Brief Summary

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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.

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Detailed Description

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• 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.

Conditions

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Preterm Infant Placental Insufficiency Placental Transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B

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

Group Type ACTIVE_COMPARATOR

Delayed cord clamping

Intervention Type PROCEDURE

Cord clamping 60 seconds after delivery of fetus in preterm infants

Group C

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

Group Type ACTIVE_COMPARATOR

Delayed cord clamping

Intervention Type PROCEDURE

Cord clamping 60 seconds after delivery of fetus in preterm infants

Interventions

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Delayed cord clamping

Cord clamping 60 seconds after delivery of fetus in preterm infants

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

0 Minutes

Maximum Eligible Age

1 Minute

Eligible Sex

ALL

Accepts Healthy Volunteers

No