- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02659605
Cord Clamping Level Above or Below Mother's Perineum (CLAMP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will compare the difference in neonatal hematocrit with delayed cord clamping above vs. below the perineum, in infants who are born via pre-term spontaneous vaginal deliveries that are vigorous at delivery. Delayed cord clamping below the perineum is an accepted clinical practice in obstetrics and gynecology; however, delayed cord clamping above the perineum has not yet been studied in preterm infants. Delayed cord clamping above the perineum will provide the benefit of immediate skin-to-skin contact between the mother and her newborn.
Patients will have delayed cord clamping performed for 60-75 seconds either below the maternal perineum or while the infant is placed on the mother's abdomen. At approximately 24 hours after delivery (at the time of infant heel stick for routine, state-mandated screening tests), a small additional amount of blood will be collected to evaluate newborn hematocrit.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- Children's Memorial Hermann Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Singleton intrauterine pregnancies at least 30 weeks gestation but less than 37 weeks gestation
Exclusion Criteria:
- Acute febrile illnesses or chronic medical problems such as hypertension, diabetes mellitus, renal disease, medically-managed seizure disorders
- Pregnancy-related complications such as pre-eclampsia, intrauterine growth restriction, chromosomal/anatomical abnormalities, and placental abruption
- Infants who are not anticipated to undergo spontaneous vaginal delivery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Delayed cord clamping above the perineum
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After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
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Active Comparator: Delayed cord clamping below the perineum
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The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hematocrit Level
Time Frame: 24 hours after delivery
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24 hours after delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Time Frame: during the initial hospital stay (1-2 days)
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during the initial hospital stay (1-2 days)
|
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Number of Participants With Infants Who Received Phototherapy
Time Frame: during the initial hospital stay (1-2 days)
|
during the initial hospital stay (1-2 days)
|
|
Number of Participants With Infants Who Received Blood Transfusion
Time Frame: during the initial hospital stay (1-2 days)
|
during the initial hospital stay (1-2 days)
|
|
Apgar Score at 1 Minute
Time Frame: 1 minute after birth
|
The Apgar score is a method to quickly summarize the health of newborn children.
The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained.
The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.
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1 minute after birth
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Apgar Score at 5 Minutes
Time Frame: 5 minutes after birth
|
The Apgar score is a method to quickly summarize the health of newborn children.
The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained.
The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.
|
5 minutes after birth
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Collaborators and Investigators
Investigators
- Principal Investigator: Pamela Berens, MD, The University of Texas Health Science Center, Houston
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-11-0633
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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