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Completed

NCT Number: NCT02659605

Cord Clamping Level Above or Below Mother's Perineum

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delayed cord clamping above the perineum

Procedure

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

Procedure

The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.

Primary outcomes

  1. Hematocrit Level

    Time frame: 24 hours after delivery

Secondary outcomes

  1. 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)

  2. Number of Participants With Infants Who Received Phototherapy

    Time frame: during the initial hospital stay (1-2 days)

  3. Number of Participants With Infants Who Received Blood Transfusion

    Time frame: during the initial hospital stay (1-2 days)

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: CLAMP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2016
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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