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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Timing of Umbilical Cord Clamping After Vaginal or Cesarean Preterm Birth

Conditions
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Preterm Birth

Intervention / Treatment
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* Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cord Clamp 20 Seconds After Delivery<br>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<br>* None to add<br>* Other names: Clamping of umbilical cord following either preterm vaginal or cesarean delivery;|
| Active Comparator: Cord Clamp 40 seconds After Delivery<br>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<br>* None to add<br>* Other names: Clamping of umbilical cord following either preterm vaginal or cesarean delivery;|
| Active Comparator: Cord Clamp 60 seconds After Delivery<br>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<br>* None to add<br>* Other names: Clamping of umbilical cord following either preterm vaginal or cesarean delivery;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Timing of Umbilical Cord clamping, Cord Clamp 20 seconds, Cord Clamp 40 seconds, Cord Clamp 60 seconds