Clinical trial NCT02229162: Delayed Umbilical Cord Clamping - C-section Pilot
Official title: Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Sections
Keywords: umbilical cord
cesarean section
Blood Loss, Surgical
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-09-01
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: maternal estimated blood loss (EBL)
timeFrame: at delivery (approximately 1 hour duration)
Secondary outcomes:
measure: neonatal hypothermia
timeFrame: at admission (within 30 minutes of birth)
measure: newborn hemoglobin concentration and hematocrit
timeFrame: first day of life (0-24 h of age)
Other outcomes:
measure: phototherapy
timeFrame: < 14 days of age
measure: Neonatal intensive care (NICU) 'observation' or admission
timeFrame: birth hospitalization (first 72 h of age approximately)
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Caroline Chantry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.