Delayed Umbilical Cord Clamping - C-section Pilot
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|ClinicalTrials.gov Identifier: NCT02229162|
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : May 30, 2017
|Condition or disease|
Despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord clamping remains a common obstetrical practice. The World Health Organization has noted that data on cesarean deliveries are more limited, particularly with respect to long-term effects in infants. Recently, the American College of Obstetrics and Gynecology also noted in a committee statement that " the ideal time for clamping of the umbilical cord in cesarean section vs. vaginal birth is a particularly important area for future research".
The objective of this study is to conduct a pilot trial of delayed cord clamping during cesarean deliveries to determine if progressively longer intervals of cord clamping are feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes from historical controls. We will offer study entry for women planning elective cesarean delivery to collect prospective data on progressively longer intervals, analyzing outcomes for each time interval to ensure they are clinically acceptable, prior to extending the interval another 30 s. We anticipate approximately 20 women at each interval (90 and 120 sec) and will perform hemoglobin analysis on the infants specifically for this study. If intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable, the cord will be clamped.
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Official Title:||Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||November 2014|
90 seconds DCC
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
Two minutes DCC
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.
- maternal estimated blood loss (EBL) [ Time Frame: at delivery (approximately 1 hour duration) ]
Excessive EBL will be assessed by three measures
- clinical assessment by anesthesia/obstetrics after surgery noting amount of blood suctioned and on drapes, to include weighing of drapes at > 800 mL
- difference between pre- and post-op hemoglobin levels of > 20% more than that in baseline data
- need for transfusion,
- neonatal hypothermia [ Time Frame: at admission (within 30 minutes of birth) ]moderate or severe neonatal hypothermia (36.2 rectal or less)
- newborn hemoglobin concentration and hematocrit [ Time Frame: first day of life (0-24 h of age) ]mean hemoglobin concentration and incidence of polycythemia (hct >65 with symptoms, 70 without symptoms) and anemia (hgb <14.5 g/dL)
- phototherapy [ Time Frame: < 14 days of age ]phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life
- Neonatal intensive care (NICU) 'observation' or admission [ Time Frame: birth hospitalization (first 72 h of age approximately) ]NICU 'observation' during transition or admission will be measured and reason for admission. respiratory symptoms are most of interest, but historical controls will only have data yes/no so we will look at overall nicu admissions also.
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): NCT02229162
|United States, California|
|University of California Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Caroline Chantry, MD||University of California, Davis|