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

Preterm Birth Clinical Trial

— CordClamp  

Official title:

Timing of Umbilical Cord Clamping After Vaginal or Cesarean Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766908
• Other study ID #: 2011-0270
• Status: Completed
• Phase: N/A
• First received: January 9, 2013
• Last updated: December 15, 2014
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery
None to add

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center, Winfred L. Wiser Hospital for Women and Infants	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No