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

Primary Purpose

Pre-term Birth, Delayed Cord Clamping

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed cord clamping above the perineum
Delayed cord clamping below the perineum
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pre-term Birth focused on measuring pre-term birth, delayed cord clamping, skin to skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Memorial Hermann Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Delayed cord clamping above the perineum

Delayed cord clamping below the perineum

Arm Description

Outcomes

Primary Outcome Measures

Hematocrit Level

Secondary Outcome Measures

Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Number of Participants With Infants Who Received Phototherapy
Number of Participants With Infants Who Received Blood Transfusion
Apgar Score at 1 Minute
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.
Apgar Score at 5 Minutes
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.

Full Information

First Posted
January 15, 2016
Last Updated
January 31, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02659605
Brief Title
Cord Clamping Level Above or Below Mother's Perineum
Acronym
CLAMP
Official Title
Cord Clamping Level Above or Below Mother's Perineum
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-term Birth, Delayed Cord Clamping
Keywords
pre-term birth, delayed cord clamping, skin to skin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delayed cord clamping above the perineum
Arm Type
Experimental
Arm Title
Delayed cord clamping below the perineum
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Delayed cord clamping above the perineum
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Delayed cord clamping below the perineum
Intervention Description
The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
Primary Outcome Measure Information:
Title
Hematocrit Level
Time Frame
24 hours after delivery
Secondary Outcome Measure Information:
Title
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)
Title
Number of Participants With Infants Who Received Phototherapy
Time Frame
during the initial hospital stay (1-2 days)
Title
Number of Participants With Infants Who Received Blood Transfusion
Time Frame
during the initial hospital stay (1-2 days)
Title
Apgar Score at 1 Minute
Description
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.
Time Frame
1 minute after birth
Title
Apgar Score at 5 Minutes
Description
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.
Time Frame
5 minutes after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Berens, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26651542
Citation
Mansaray A, Yetman R, Berens P. Effect of Delayed Cord Clamping Above Versus Below the Perineum on Neonatal Hematocrit: A Randomized Controlled Trial. Breastfeed Med. 2015 Dec;10(10):464-7. doi: 10.1089/bfm.2015.0109.
Results Reference
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Cord Clamping Level Above or Below Mother's Perineum

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