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

NCT ID: NCT01766908

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-06-30

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.

Conditions

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Preterm Birth

Keywords

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Timing of Umbilical Cord clamping Cord Clamp 20 seconds Cord Clamp 40 seconds Cord Clamp 60 seconds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cord Clamp 20 Seconds After Delivery

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

None to add

Cord Clamp 40 seconds After Delivery

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

None to add

Cord Clamp 60 seconds After Delivery

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

None to add

Interventions

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

None to add

Intervention Type OTHER

Other Intervention Names

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Clamping of umbilical cord following either preterm vaginal or cesarean delivery

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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James Martin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Martin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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2011-0270

Identifier Type: -

Identifier Source: org_study_id