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

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery

• Registration Number: NCT01766908
• Lead Sponsor: University of Mississippi Medical Center

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-11
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cord Clamp 20 Seconds After Delivery	Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery	Intervention is cord clamp at 20 seconds following vaginal or cesarean delivery
Cord Clamp 40 seconds After Delivery	Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery	Timing of cord clamp at 40 seconds following vaginal or cesarean delivery.
Cord Clamp 60 seconds After Delivery	Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery	Intervention is timing of cord clamp at 60 seconds following vaginal or cesarean delivery

Primary Outcome Measures

Name	Time	Method
Intraventricular Hemorrhage number and severity	15 months	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

Name	Time	Method
Incidence and volume of red cell transfusion for newborns.	15 months	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.

Trial Locations

Locations (1)

University of Mississippi Medical Center, Winfred L. Wiser Hospital for Women and Infants; 🇺🇸 Jackson, Mississippi, United States