The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in Preterms
NCT ID: NCT03023917
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
284 participants
INTERVENTIONAL
2017-06-30
2019-12-31
Brief Summary
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Detailed Description
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Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy because of increased iron stores at birth. However there are controversies in incorporating delayed cord clamping practice in the management of third stage of labour globally. Concerning about the need for urgent resuscitation and temperature management, attendants encouraged to clamp the umbilical cord immediately so that post-natal resuscitation and care can start as soon as possible.However,umbilical cord milking allows for swift intervention and resuscitation and attention to thermal care and should take less than 10 seconds to complete.
The specific aim of this study is to investigate the effects of umbilical cord milking on preventing and decreasing anemia in very pre-term infants.
Primary Outcomes:
Hemoglobin (Hb), Hematocrit (Hct) and serum iron levels at birth, at 1 week,at 2 weeks of age.
Secondary Outcomes:
* Hemoglobin,hematocrit levels at 6 months of age.
* Anemia at 1 week of life and 6 months follow-up, defined as hemoglobin levels below the respective cutoffs.
* number of blood transfusions until 3 months corrected gestational age (CGA).
* short term clinical profile of neonates like jaundice, polycythemia etc.
* preterm infant complications such as lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), and cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected patent ductus arteriosus(PDA )requiring intervention prior to discharge home,incidence of intraventricular hemorrhage and late-onset sepsis,etc.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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umbilical cord clamping immediately
Umbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders. (This was standard practice in the study hospital, thus it served as the "control" group).
umbilical cord clamping immediately
umbilical cord was cut immediately after birth
umbilical cord milking
preterm baby were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
umbilical cord milking
Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
Interventions
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umbilical cord milking
Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
umbilical cord clamping immediately
umbilical cord was cut immediately after birth
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* informed consent was obtained from the parent
Exclusion Criteria
* Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus,anemia
* Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies
* Diagnosis at any time for the mother of any of the following: serious Diabetes, serious hypertension, chronic renal disease
* Infant with major congenital malformation
* Infant with blood disease
* Unwilling to return for follow-up study visits at the hospital
ALL
No
Sponsors
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Shanghai First Maternity and Infant Hospital
OTHER
Yangpu District Central Hospital Affiliated to Tongji University
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Lijuan Xie
Principal Investigator
Principal Investigators
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guangyu chen
Role: STUDY_CHAIR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Xinhua Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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XH-16-050
Identifier Type: -
Identifier Source: org_study_id