Milking Versus Delayed Cord Clamping in Full Term Neonates

Not Applicable

Completed

Conditions: Neonatal Anemia

Registration Number: NCT02454101

Lead Sponsor: Ahmed Mohamed El Kotb Abdel Fattah

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 300

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neonatal Hemoglobin Level	6 weeks after labor	neonatal 6 weeks hemoglobin measured in gram %

Secondary Outcome Measures

Name	Time	Method
Jundice Requring Phtotherapy	two weks	number of infants requiring phtotherapy for jundice in the first 2 weeks
Severe Postpartum Haemorrage	24 hours after labor	(measured blood loss 1000 mL or more
Neonatal Apgar Score (After 5 Minutes of Delivery).	5 minutes of delivery	* The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's: 1. Breathing effort 2. Heart rate 3. Muscle tone 4. Reflexes 5. Skin color * Each category is scored with 0, 1, or 2, depending on the observed condition. * The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. * A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth. * Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs
Maternal Additional Need for Therapeutic Uterotonics	1st 24 hours of delivery	number of mothers need for \> 20 units of Oxycontin in the 1st 24 hours of delivery
Neonatal Intubation	1st 2 hours after delivery	number of newborns requirng intubation in the first 2 hours after delivery
Neonatal Intensive Care Unit (NICU) Admission	1st 24 hours after delivery	number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery
Maternal Need for Blood Transfusion.	1st 24 hours after delivery	number of mothers with hemoglobin level \< 7mg/dl and need for blood transfusion
Duration of Third Stage of Labor	immediatly after delivery	number of minutes from delivery of the baby till delivery of the placenta