NCT05551390

Brief Summary

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

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 May 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

September 6, 2022

Last Update Submit

September 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was neonatal Hb level

    neonatal Hb level

    48-72 hour after birth

Study Arms (2)

one-time umbilical cord milking

EXPERIMENTAL

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

three-time umbilical cord milking

EXPERIMENTAL

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

Interventions

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.

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.

three-time umbilical cord milking

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wachira Prachakittikul

Chon Buri, Changwat Chon Buri, 20110, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 22, 2022

Study Start

May 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations