Effect of One-time Versus Three-times of Umbilical Cord Milking on Neonatal Hemoglobin in Late Preterm (RRT)

Effect of One-time Versus Three-times of Umbilical Cord Milking on Neonatal Hemoglobin in Late Preterm: A Randomized Controlled Trial

To compare the neonatal hemoglobin (Hb) in late preterm between one-time versus three-times of umbilical cord milking (UCM)

Study Overview

• Status: Completed
• Conditions: Umbilical Cord Milking
• Intervention / Treatment: Other: one-time umbilical cord milking; Other: three-times umbilical cord milking

Detailed Description

This was a double-blind randomized controlled trial that performed between May 2021 to March 2022 at the Obstetrics and Gynecology Department of Queen Savang Vadhana Memorial Hospital. Late preterm pregnant women (34-36+6 week's gestation) that exclude placenta accrete/percreta, placenta previa, placental abruption, congenital anomaly and hydrops fetalis, were randomized in a 1:1 ratio to either one-time or three-times UCM. The primary outcome was neonatal Hb level at 48-72 hour after birth.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chonburi
    • Chon Buri, Chonburi, Thailand, 20110
      • Wachira Prachakittikul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Late preterm pregnant women (34-36+6 week's gestation)

Exclusion Criteria:

• placenta accrete
• placenta percreta
• placenta previa
• placental abruption
• congenital anomaly
• hydrops fetalis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one-time umbilical cord milking; Before UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision. Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics.	Other: one-time umbilical cord milking; Before UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision. Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics.
Experimental: three-time umbilical cord milking; Before UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision. Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics.	Other: three-times umbilical cord milking; Before UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision. Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome was neonatal Hb level	neonatal Hb level	48-72 hour after birth

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 010/2564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No