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Cord Clamping Level Above or Below Mother's Perineum (CLAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659605
Recruitment Status : Unknown
Verified January 2016 by Pamela Berens, The University of Texas Health Science Center, Houston.
Recruitment status was:  Not yet recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Pamela Berens, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to determine if delayed cord clamping above the perineum has an effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in pre-term spontaneous vaginal deliveries.

Condition or disease Intervention/treatment Phase
Pre-term Birth Delayed Cord Clamping Procedure: Delayed cord clamping above the perineum Procedure: Delayed cord clamping below the perineum Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cord Clamping Level Above or Below Mother's Perineum
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017

Arm Intervention/treatment
Experimental: Delayed cord clamping above the perineum Procedure: Delayed cord clamping above the perineum
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.

Active Comparator: Delayed cord clamping below the perineum Procedure: Delayed cord clamping below the perineum
The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.




Primary Outcome Measures :
  1. Hematocrit level [ Time Frame: 24 hours after delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659605


Contacts
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Contact: Pamela Berens, MD (713) 500-6471 Pamela.D.Berens@uth.tmc.edu

Locations
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United States, Texas
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
Contact: Pamela Berens, MD    713-500-6471    Pamela.D.Berens@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Pamela Berens, MD The University of Texas Health Science Center, Houston
Publications:
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Responsible Party: Pamela Berens, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02659605    
Other Study ID Numbers: HSC-MS-11-0633
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pamela Berens, The University of Texas Health Science Center, Houston:
pre-term birth
delayed cord clamping
skin to skin
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications