NCT05951348

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
Last Updated

July 21, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

July 6, 2023

Last Update Submit

July 20, 2023

Conditions

Umbilical Cord Milking

Keywords

cesarean sectionumbilical cord milkinghemoglobin

Outcome Measures

Primary Outcomes (1)

  • hemoglobin level

    a blood sample is taken from the umbilical cord of the neonate

    immediately after the intervention

Secondary Outcomes (1)

  • bilirubin level

    72 hours after delivery

Study Arms (3)

Immediate cord clamping

NO INTERVENTION

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

Delayed cord clamping

EXPERIMENTAL

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

Procedure: Delayed cord clamping for 30 seconds

Umbilical cord milking

EXPERIMENTAL

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

Procedure: Delayed cord clamping for 30 seconds

Interventions

Delayed cord clamping for 30 secondsPROCEDURE

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

Also known as: Umbilical cord milking
Delayed cord clampingUmbilical cord milking

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tamer Ahmed Hosny

Alexandria, Egypt

Location

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 19, 2023

Study Start

November 11, 2021

Primary Completion

June 20, 2022

Study Completion

June 20, 2022

Last Updated

July 21, 2023

Record last verified: 2023-05

Locations

EG(1)