Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome

NCT ID: NCT05951348

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2022-06-20

Brief Summary

the study is conducted on the different actions on umbilical cord clamping including immediate cord clamping (ICC) , delayed cord clamping (DCC) for 30 seconds and umbilical cord milking (UCM) for 10-15 seconds in females that are delivered by elective cesarean section , to assess the neonatal outcomes including Hemoglobin and Hematocrit levels after birth in the newborn and the bilirubin level after 72 hrs

Detailed Description

the benefit of umbilical cord milking for 10-15 seconds maneuver in cesarean section, that short time can improve the hemoglobin level and prevent anemia in the newborn with improvement of the iron stores for months in infancy without affection on the bilirubin level and the need for phototherapy. This is significant because of the rising rate of cesarean section all over the world make more children are liable for anemia, and by this simple technique it can be prevented.

Conditions

Umbilical Cord Milking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Immediate cord clamping

this arm where the patient didn't receive any special maneuver and immediate cord clamping after delivery of the fetus is done

Group Type: NO_INTERVENTION

No interventions assigned to this group

Delayed cord clamping

this arm where the patient receive a delay in cord clamping for 30 seconds after delivery of the fetus

Group Type: EXPERIMENTAL

Delayed cord clamping for 30 seconds

Intervention Type: PROCEDURE

waiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds

Umbilical cord milking

this arm where the patient receive stripping of the umbilical cord in the direction of the fetus 10 times in a time frame 10-15 seconds after delivery of the fetus

Group Type: EXPERIMENTAL

Delayed cord clamping for 30 seconds

Intervention Type: PROCEDURE

waiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds

Interventions

Delayed cord clamping for 30 seconds

waiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds

Intervention Type: PROCEDURE

Other Intervention Names

Umbilical cord milking

Eligibility Criteria

Inclusion Criteria

• mother's age (20-40) years.
• pregnancy with a healthy singleton
• gestational age of 38-41 0/7 weeks
• uncomplicated pregnancy

Exclusion Criteria

• Any medical or obstetrical complications like hypertension, pre-eclampsia, diabetes any special habits like smoking, and substance abuse
• fetus with evidence of intrauterine growth restriction
• infant with serious congenital anomalies.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tamer Ahmed Hosny

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0106748

Identifier Type: -

Identifier Source: org_study_id