NCT02229162|CompletedDMC
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Sponsor study identifier
observational
41
1 country
1
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
November 2014
Actual (reported)This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90 to 120 seconds) during elective cesarean deliveries of term infants. The investigators hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this procedure for mothers and babies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 22, 2014
Actual (reported)September 1, 2014
Actual (reported)October 2014
Actual (reported)November 2014
Actual (reported)maternal estimated blood loss (EBL)
Excessive EBL will be assessed by three measures 1. clinical assessment by anesthesia/obstetrics after surgery noting amount of blood suctioned and on drapes, to include weighing of drapes at \> 800 mL 2. difference between pre- and post-op hemoglobin levels of \> 20% more than that in baseline data 3. need for transfusion,
at delivery (approximately 1 hour duration)
neonatal hypothermia
at admission (within 30 minutes of birth)
newborn hemoglobin concentration and hematocrit
first day of life (0-24 h of age)
phototherapy
< 14 days of age
Neonatal intensive care (NICU) 'observation' or admission
birth hospitalization (first 72 h of age approximately)
the initial 15-20 subjects (15 enrolled subjects who complete study) will have cord clamped at 90 seconds. Then data will be analyzed and evaluated by DSMB
If Data Safety Monitoring Board (DSMB) concurs, DCC will then be practiced for 2 minutes for second group, which is the minimum amount of time recommended to be defined as DCC.
pregnant women 18 years of age or older that plan on having an elective Cesarean delivery of a term singleton infant.
University of California Davis Medical Center
Sacramento, California, 95817, United States
Chantry CJ, Blanton A, Tache V, Finta L, Tancredi D. Delayed cord clamping during elective cesarean deliveries: results of a pilot safety trial. Matern Health Neonatol Perinatol. 2018 Jul 4;4:16. doi: 10.1186/s40748-018-0083-3. eCollection 2018.
Caroline Chantry, MD
University of California, Davis
41 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2014
First Posted
September 1, 2014
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Using the Peanut Exercise Ball to Reduce Cesarean Section Rates: A Randomized Controlled Trial
Contact the study team to confirm eligibility.
Primary Completion
October 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
May 30, 2017
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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