Delayed Umbilical Cord Clamping - C-section Pilot

Completed

• Conditions: Cesarean Sections

• Registration Number: NCT02229162
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-09-01
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2016-02
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
maternal estimated blood loss (EBL)	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

Name	Time	Method
neonatal hypothermia	at admission (within 30 minutes of birth)	moderate or severe neonatal hypothermia (36.2 rectal or less)
newborn hemoglobin concentration and hematocrit	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)

Trial Locations

Locations (1)

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States