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

University of Mississippi

Status: Completed

Conditions: Preterm Birth

Treatments: Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT01766908

2011-0270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups

Cord Clamp 20 Seconds After Delivery

Active Comparator group

Description:

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

Treatment:

Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery

Cord Clamp 40 seconds After Delivery

Active Comparator group

Description:

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

Treatment:

Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery

Cord Clamp 60 seconds After Delivery

Active Comparator group

Description:

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

Treatment:

Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery