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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
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease
Cesarean Sections

Detailed Description:

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
Observational Model: Other
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort
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.



Primary Outcome Measures :
  1. maternal estimated blood loss (EBL) [ Time Frame: at delivery (approximately 1 hour duration) ]

    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,


Secondary Outcome Measures :
  1. neonatal hypothermia [ Time Frame: at admission (within 30 minutes of birth) ]
    moderate or severe neonatal hypothermia (36.2 rectal or less)

  2. 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)


Other Outcome Measures:
  1. phototherapy [ Time Frame: < 14 days of age ]
    phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant women 18 years of age or older that plan on having an elective Cesarean delivery of a term singleton infant.
Criteria

Inclusion Criteria:Subjects that are pregnant (women 18 years of age and older) and scheduled for an elective C-section at ≥ 37 weeks gestation will be eligible for the study.

Exclusion Criteria:

Pregnant women that do not plan on having a C-section and individuals that are not pregnant. Pregnant women that are medically unstable, have poorly controlled diabetes mellitus, multiple gestations, anomalous fetuses and/or severe intrauterine growth retardation will be excluded. Adults unable to consent will not be included


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): NCT02229162


Locations
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Caroline Chantry, MD University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02229162     History of Changes
Other Study ID Numbers: 400656-4
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, Davis:
umbilical cord
cesarean section
Blood Loss, Surgical