NCT04463485

Brief Summary

This research was conducted to carry out the effect of umbilical cord clamping time on baby anemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

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

December 21, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

July 4, 2020

Last Update Submit

July 8, 2020

Conditions

Keywords

umbilical cordclampinginfantanemiamidwifery

Outcome Measures

Primary Outcomes (6)

  • Neonatal Haematocrit Value at 48th Hours of Life

    Haematocrit measurement in capillary blood taken from newborn after birth

    48th hours after birth

  • Neonatal Bilirubin Value at 48th Hours of Life

    Bilirubin measurement in capillary blood taken from newborn after birth

    48th hours after birth

  • Phototherapy Requirement Rates due to Hyperbilirubinemia

    Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period

    3 or 14 days of age

  • Haemoglobin Values of 4 Month Infants

    Haemoglobin measurement at baby's 4th month of age

    Infants' 4th month of age

  • Haematocrit Values of 4 Month Infants

    Haematocrit measurement at baby's 4th month of age

    Infants' 4th month of age

  • Diagnosis of Anemia Rates of 4 Month Infants

    Screening of the family medicine center, condition of the baby diagnosed with anemia at 4th month of age

    Infants' 4th month of age

Study Arms (2)

Delayed Clamping

EXPERIMENTAL

The intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor.

Procedure: Delayed Clamping

Early Clamping

NO INTERVENTION

No interventions have been assigned.

Interventions

Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.

Delayed Clamping

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apply for normal birth
  • Singleton pregnancy and live fetus
  • Cephalic presentation
  • Estimated birth weight between 2500-4000 grams
  • Birth rates \<5
  • Women who received iron support during pregnancy
  • Haemoglobin level ≥ 11 gr/dL
  • No systemic disease or pregnancy complication that may pose a risk for postpartum bleeding.
  • Neonates who don't need for resuscitation after birth
  • Babies who did not receive iron supplements up to the 4th month after birth were included.

You may not qualify if:

  • Pregnant women who refuse to participate in the research
  • Neonates who need for resuscitation after birth
  • Babies who receive iron supplements up to the 4th month after birth were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Medical Hospital Obstetric and Gynecology Department

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anemia

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Birsen Saydam

    Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 4, 2020

First Posted

July 9, 2020

Study Start

December 21, 2017

Primary Completion

August 30, 2018

Study Completion

December 30, 2018

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations