Clinical trial NCT02659605: Cord Clamping Level Above or Below Mother's Perineum
Official title: Cord Clamping Level Above or Below Mother's Perineum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-term Birth
Delayed Cord Clamping
Keywords: pre-term birth
delayed cord clamping
skin to skin
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Hematocrit Level
timeFrame: 24 hours after delivery
Secondary outcomes:
measure: Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
timeFrame: during the initial hospital stay (1-2 days)
measure: Number of Participants With Infants Who Received Phototherapy
timeFrame: during the initial hospital stay (1-2 days)
measure: Number of Participants With Infants Who Received Blood Transfusion
timeFrame: during the initial hospital stay (1-2 days)
measure: Apgar Score at 1 Minute
timeFrame: 1 minute after birth
measure: Apgar Score at 5 Minutes
timeFrame: 5 minutes after birth
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Pamela Berens, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.