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Cord Milking in Elective Cesarean Section

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ClinicalTrials.gov Identifier: NCT03668782
Recruitment Status : Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Vincenzo Zanardo, Policlinico Abano Terme

Brief Summary:
The objective of the study was to investigate the efficacy and safety of umbilical cord milking as compared with immediate cord clamping on placental transfusion, estimated by Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age, in elective cesarean delivered neonates.

Condition or disease Intervention/treatment
Placental Transfusion Procedure: Umbilical cord milking

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Efficacy of Umbilical Cord Milking in Elective Cesarean Section
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
immediate cord clamping
Tthe umbilical cord of neonates was cut and clamped.
Procedure: Umbilical cord milking
The babies were held at the level of the placenta, while the umbilical cord was milked or cut and clamped.
Other Name: Immediate cord clamping

umbilical cord milking.
Tthe umbilical cord of neonates was milked.
Procedure: Umbilical cord milking
The babies were held at the level of the placenta, while the umbilical cord was milked or cut and clamped.
Other Name: Immediate cord clamping




Primary Outcome Measures :
  1. Placental transfusion [ Time Frame: 48 hours ]
    Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age


Biospecimen Retention:   Samples With DNA
After the infant was delivered, the obstetrician either immediately clamped and cut the cord or initiated the milking protocol intervention, near the cord insertion site on the placenta towards the infant, three times before clamping.


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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All women who presented for an elective cesarean section were screened for eligibility.
Criteria

Inclusion Criteria: singleton low risk pregnancy, gestational age of 39 to 40/0 weeks confirmed by a first trimester ultrasound, no evidence of active labor, 18 years of age, and (5) a written consent given by the woman.

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Exclusion Criteria:maternal medical and obstetric complications, severe anemia, clotting disorders and suspected intrauterine growth restriction

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668782


Locations
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Italy
Policlinico Abano Terme Not yet recruiting
Abano Terme, Italy
Contact: Vincenzo Zanardo, ND    049720027 ext +39    viincenzo.zanardo@libero.it   
Sponsors and Collaborators
Policlinico Abano Terme

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Responsible Party: Vincenzo Zanardo, Director of Perinatal Medicine, Policlinico Abano Terme
ClinicalTrials.gov Identifier: NCT03668782     History of Changes
Other Study ID Numbers: 24/2018 Fondazione Leonardo
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No