Delayed Umbilical Cord Clamping - C-section Pilot

Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal estimated blood loss (EBL)	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,	at delivery (approximately 1 hour duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal hypothermia	moderate or severe neonatal hypothermia (36.2 rectal or less)	at admission (within 30 minutes of birth)
newborn hemoglobin concentration and hematocrit	mean hemoglobin concentration and incidence of polycythemia (hct >65 with symptoms, 70 without symptoms) and anemia (hgb <14.5 g/dL)	first day of life (0-24 h of age)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
phototherapy	phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life	< 14 days of age
Neonatal intensive care (NICU) 'observation' or admission	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.	birth hospitalization (first 72 h of age approximately)

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): September 1, 2014

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: cesarean section; umbilical cord; Blood Loss, Surgical
• Other Study ID Numbers: 400656-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO