Optimal Timing of Cord Clamping in Preterm Pregnancy Following Vaginal or Cesarean Delivery (CordClamp)

Timing of Umbilical Cord Clamping After Vaginal or Cesarean Preterm Birth

This is an experimental research study for pregnant women between 23 and 37 weeks age of gestation who will be having a baby sooner than term. This study is to learn if waiting 20, 40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her outcome and overall health. Benefit to the baby may come by increasing the amount of blood in the baby's body, reducing the need for possible transfusion later, and possible prevention of other complications caused by too little blood in the baby. Possible reduction of cerebral palsy may be realized by a longer interval for cord clamping.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery

Detailed Description

Intention is to enroll every preterm delivery into this trial containing six groups of patients, vaginal or cesarean delivery with clamping of the cord at 20, 40 or 60 seconds. Expectation is 1500 deliveries over 2 year period of time. Randomization upon entry to L&D unit. Removal from study if resuscitation deemed urgent by newborn staff. Strong effort to keep newborn warm using appropriate measures. Evaluation to determine if there are differences in transfusion, anemia, time to onset of spontaneous respiration, occurence of IVH or CP.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center, Winfred L. Wiser Hospital for Women and Infants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

18 years old singleton gestation Between 23-37 weeks gestation Able to understand and sign informed consent

Exclusion Criteria:

multiple gestation/ known intrauterine fetal death unable to sign consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cord Clamp 20 Seconds After Delivery; Intervention is cord clamp at 20 seconds following vaginal or cesarean delivery	Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery; None to add; Other Names: Clamping of umbilical cord following either preterm vaginal or cesarean delivery
Active Comparator: Cord Clamp 40 seconds After Delivery; Timing of cord clamp at 40 seconds following vaginal or cesarean delivery.	Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery; None to add; Other Names: Clamping of umbilical cord following either preterm vaginal or cesarean delivery
Active Comparator: Cord Clamp 60 seconds After Delivery; Intervention is timing of cord clamp at 60 seconds following vaginal or cesarean delivery	Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery; None to add; Other Names: Clamping of umbilical cord following either preterm vaginal or cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraventricular Hemorrhage number and severity	WE are seeking the length of time to delay cord clamping for various gestational age groups following vaginal or cesarean delivery in order to significantly improve primary outcome.	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and volume of red cell transfusion for newborns.	Benefits will be significantly better with very preterm deliveries compared to those delivered from 29-36 weeks gestation. These benefits will include a lower incidence of transfusion and less frequent/less severe intraventricular hemorrhage in new borns.	15 months

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Investigators: Principal Investigator: James Martin, MD, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 10, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2014
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Timing of Umbilical Cord clamping; Cord Clamp 20 seconds; Cord Clamp 40 seconds; Cord Clamp 60 seconds
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2011-0270