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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Pre-term Birth
Delayed Cord Clamping

Treatments

Procedure: Delayed cord clamping below the perineum
Procedure: Delayed cord clamping above the perineum

Study type

Interventional

Funder types

Other

Identifiers

NCT02659605
HSC-MS-11-0633

Details and patient eligibility

About

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.

Full 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.

Enrollment

103 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

103 participants in 2 patient groups

Delayed cord clamping above the perineum
Experimental group
Treatment:
Procedure: Delayed cord clamping above the perineum
Delayed cord clamping below the perineum
Active Comparator group
Treatment:
Procedure: Delayed cord clamping below the perineum

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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