search
Back to results

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

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Preterm Birth focused on measuring Timing of Umbilical Cord clamping, Cord Clamp 20 seconds, Cord Clamp 40 seconds, Cord Clamp 60 seconds

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cord Clamp 20 Seconds After Delivery

Cord Clamp 40 seconds After Delivery

Cord Clamp 60 seconds After Delivery

Arm Description

Intervention is cord clamp at 20 seconds following vaginal or cesarean delivery

Timing of cord clamp at 40 seconds following vaginal or cesarean delivery.

Intervention is timing of cord clamp at 60 seconds following vaginal or cesarean delivery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 9, 2013
Last Updated
December 15, 2014
Sponsor
University of Mississippi Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01766908
Brief Title
Optimal Timing of Cord Clamping in Preterm Pregnancy Following Vaginal or Cesarean Delivery
Acronym
CordClamp
Official Title
Timing of Umbilical Cord Clamping After Vaginal or Cesarean Preterm Birth
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Timing of Umbilical Cord clamping, Cord Clamp 20 seconds, Cord Clamp 40 seconds, Cord Clamp 60 seconds

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cord Clamp 20 Seconds After Delivery
Arm Type
Active Comparator
Arm Description
Intervention is cord clamp at 20 seconds following vaginal or cesarean delivery
Arm Title
Cord Clamp 40 seconds After Delivery
Arm Type
Active Comparator
Arm Description
Timing of cord clamp at 40 seconds following vaginal or cesarean delivery.
Arm Title
Cord Clamp 60 seconds After Delivery
Arm Type
Active Comparator
Arm Description
Intervention is timing of cord clamp at 60 seconds following vaginal or cesarean delivery
Intervention Type
Other
Intervention Name(s)
Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery
Other Intervention Name(s)
Clamping of umbilical cord following either preterm vaginal or cesarean delivery
Intervention Description
None to add
Primary Outcome Measure Information:
Title
Intraventricular Hemorrhage number and severity
Description
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.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Incidence and volume of red cell transfusion for newborns.
Description
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.
Time Frame
15 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Martin, MD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center, Winfred L. Wiser Hospital for Women and Infants
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs