Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Neonatal Hemoglobin Level
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
cord milking
milking of the umbilical cord 5 times toward the neonate
Intervention: delayed cord clamping (Procedure)
delayed cord clamping
delayed cord clamping for 120 seconds
Intervention: cord milking (Procedure)
Outcomes
Primary Outcomes
Neonatal Hemoglobin Level
Time Frame: 6 weeks after labor
neonatal 6 weeks hemoglobin measured in gram %
Secondary Outcomes
- Jundice Requring Phtotherapy(two weks)
- Severe Postpartum Haemorrage(24 hours after labor)
- Neonatal Apgar Score (After 5 Minutes of Delivery).(5 minutes of delivery)
- Maternal Additional Need for Therapeutic Uterotonics(1st 24 hours of delivery)
- Neonatal Intubation(1st 2 hours after delivery)
- Neonatal Intensive Care Unit (NICU) Admission(1st 24 hours after delivery)
- Maternal Need for Blood Transfusion.(1st 24 hours after delivery)
- Duration of Third Stage of Labor(immediatly after delivery)
Investigators
Ahmed Mohamed El Kotb Abdel Fattah
Principal Investigator
Ain Shams University