Clinical trial NCT02454101: Milking Versus Delayed Cord Clamping in Full Term Neonates
Official title: Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Anemia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the short term risks and benefits of cord milking 5 times toward the neonate with delayed cord clamping for 120 seconds in the full term neonate delivered by cesarean section.

Detailed description: Abstract Context: milking of the umbilical cord toward the neonate 5 times and delayed cord clamping both are good procedures to prevent anemia in neonates .

Objective: To investigate the effects of delayed umbilical cord clamping for 120 seconds, compared with milking of the cord 5 times toward the neonate on hemoglobin level after 6 weeks, Intubation,Respiratory distress,Clinical jaundice,Neonatal Intensive Care unit (NICU) admission,Apgar score (after 5 minutes of delivery).

-Maternal,Need for blood transfusion,Additional need for therapeutic uterotonics,Post postpartum hemorrhage (blood loss \> 500cc),Intensive Care unit admission.

Design: Randomized controlled trial. Setting: Ain Shams university maternity hospital. Participants:300 full term infants born after a low risk pregnancy by cesarean section delivery.

Intervention: Infants were randomized to delayed umbilical cord clamping (≥120 seconds after delivery) or cord milking (5 times to ward the neonate).

Eligibility criteria: Inclusion Criteria:

* Pregnant females going for cesarean section that completed 37 weeks of gestation
* Medically free

Exclusion Criteria:

* Known congenital anomalies of fetus.
* Rhesus sensitization.
* Fetal hydrops.
* Medical disorder (preeclampsia - diabetes mellitus - hypertension - SLE).
* Need for urgent resuscitation.
* Multiple pregnancies.

Primary outcomes:
measure: Neonatal Hemoglobin Level
timeFrame: 6 weeks after labor
Secondary outcomes:
measure: Jundice Requring Phtotherapy
timeFrame: two weks
measure: Severe Postpartum Haemorrage
timeFrame: 24 hours after labor
measure: Neonatal Intubation
timeFrame: 1st 2 hours after delivery
measure: Neonatal Intensive Care Unit (NICU) Admission
timeFrame: 1st 24 hours after delivery
measure: Neonatal Apgar Score (After 5 Minutes of Delivery).
timeFrame: 5 minutes of delivery
measure: Maternal Need for Blood Transfusion.
timeFrame: 1st 24 hours after delivery
measure: Maternal Additional Need for Therapeutic Uterotonics
timeFrame: 1st 24 hours of delivery
measure: Duration of Third Stage of Labor
timeFrame: immediatly after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Chams University Maternity Hospital
Study officials:
affiliation: clinical professor
name: Hazem F El Shahawy, PHD
role: PRINCIPAL_INVESTIGATOR
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