Delayed Umbilical Cord Clamping - C-section Pilot

NCT02229162 | Completed DMC

• 1 other identifier: 400656-4
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Sections

Keywords

umbilical cord; cesarean section; Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

• maternal estimated blood loss (EBL)

  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,

  at delivery (approximately 1 hour duration)

Secondary Outcomes (2)

• neonatal hypothermia

  at admission (within 30 minutes of birth)

• newborn hemoglobin concentration and hematocrit

  first day of life (0-24 h of age)

Other Outcomes (2)

• phototherapy

  < 14 days of age

• Neonatal intensive care (NICU) 'observation' or admission

  birth hospitalization (first 72 h of age approximately)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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.

  PMID: 29997897 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Caroline Chantry, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: September 1, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 30, 2017

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)