Cord Clamping Level Above or Below Mother's Perineum

Delayed Cord Clamping Clinical Trial

— CLAMP  

Official title:

Cord Clamping Level Above or Below Mother's Perineum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659605
• Other study ID #: HSC-MS-11-0633
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: January 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Cord Clamping
• Pre-term Birth
• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematocrit Level		24 hours after delivery
Secondary	Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)		during the initial hospital stay (1-2 days)
Secondary	Number of Participants With Infants Who Received Phototherapy		during the initial hospital stay (1-2 days)
Secondary	Number of Participants With Infants Who Received Blood Transfusion		during the initial hospital stay (1-2 days)
Secondary	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.	1 minute after birth
Secondary	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.	5 minutes after birth