Cord Clamping Level Above or Below Mother's Perineum
- Conditions
- Delayed Cord ClampingPre-term Birth
- Interventions
- Procedure: Delayed cord clamping below the perineumProcedure: Delayed cord clamping above the perineum
- Registration Number
- NCT02659605
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 103
- Singleton intrauterine pregnancies at least 30 weeks gestation but less than 37 weeks gestation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed cord clamping below the perineum Delayed cord clamping below the perineum - Delayed cord clamping above the perineum Delayed cord clamping above the perineum -
- Primary Outcome Measures
Name Time Method Hematocrit Level 24 hours after delivery
- Secondary Outcome Measures
Name Time Method Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU) during the initial hospital stay (1-2 days) Number of Participants With Infants Who Received Blood Transfusion during the initial hospital stay (1-2 days) Number of Participants With Infants Who Received Phototherapy during the initial hospital stay (1-2 days) Apgar Score at 1 Minute 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.
Apgar Score at 5 Minutes 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.
Trial Locations
- Locations (1)
Children's Memorial Hermann Hospital
🇺🇸Houston, Texas, United States