Milking Versus Delayed Cord Clamping in Full Term Neonates

Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial

Sponsors

Lead Sponsor: Ahmed Mohamed El Kotb Abdel Fattah

Source Ain Shams University
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).

Overall Status Completed
Start Date August 2015
Completion Date March 2016
Primary Completion Date March 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Neonatal Hemoglobin Level 6 weeks after labor
Secondary Outcome
Measure Time Frame
Jundice Requring Phtotherapy two weks
Severe Postpartum Haemorrage 24 hours after labor
Neonatal Intubation 1st 2 hours after delivery
Neonatal Intensive Care Unit (NICU) Admission 1st 24 hours after delivery
Neonatal Apgar Score (After 5 Minutes of Delivery). 5 minutes of delivery
Maternal Need for Blood Transfusion. 1st 24 hours after delivery
Maternal Additional Need for Therapeutic Uterotonics 1st 24 hours of delivery
Duration of Third Stage of Labor immediatly after delivery
Enrollment 300
Condition
Intervention

Intervention Type: Procedure

Intervention Name: cord milking

Description: milking of the cord 5 times toward the neonate

Arm Group Label: delayed cord clamping

Other Name: milking of the cord

Intervention Type: Procedure

Intervention Name: delayed cord clamping

Description: delay clamping of the cord for 120 seconds

Arm Group Label: cord milking

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.

Gender: Female

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Hazem F El Shahawy, PHD Principal Investigator clinical professor
Location
Facility: Ain Chams University Maternity Hospital
Location Countries

Egypt

Verification Date

April 2016

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Ain Shams University

Investigator Full Name: Ahmed Mohamed El Kotb Abdel Fattah

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: cord milking

Type: Other

Description: milking of the umbilical cord 5 times toward the neonate

Label: delayed cord clamping

Type: Other

Description: delayed cord clamping for 120 seconds

Acronym MDCCT
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov