Cesarean Delivery, Delayed Cord Clamping, Maternal Blood Loss, Neonatal Health
Conditions
Keywords
Maternal blood loss, Cesarean delivery, Delayed cord clamping, Neonatal health
Brief summary
The purpose of this research study is to find out how delaying cutting the umbilical cord until one minute after delivery of the baby during a cesarean impacts the amount of blood the mother loses during surgery. The study will also examine the benefits to the newborn from delayed cord clamping during cesarean.
Detailed description
After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta and the mother. The best time to cut the umbilical cord of full term babies is unknown. Traditionally, the umbilical cord is cut immediately at birth. There is however, continued blood flow from the placenta to the baby after delivery and so there may be a benefit to the baby from waiting to cut the cord until one minute after delivery. Studies show that delaying cutting the cord until at least one minute after delivery increases a full term baby's blood count in first two days of life and increases the baby's iron levels. The impact of delaying cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord has minimal impact on the mother's health when the baby is delivered vaginally, but it is not known how delaying cutting the cord impacts the mother's health (and specifically the amount of blood a mother loses at delivery) when the baby is delivered by cesarean.
Interventions
PROCEDUREUmbilical cord clamping
The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Singleton gestation * Scheduled cesarean delivery at term (\>=37 weeks)
Exclusion criteria
* Placenta previa * Placenta abruption * Intrauterine growth restriction with abnormal Dopplers * Fetal anomalies * Known fetal anemia * Planned cord blood banking * Preeclampsia * Significant maternal anemia (Hgb \<=7)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal change in hemoglobin on post-operative day #1 | Baseline to postoperative day #1 (range 1-4 days) | Difference in hemoglobin between routine pre-op CBC and a postpartum CBC collected on postoperative day #1, by venipuncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated blood loss | Day of surgery | Estimated blood loss at cesarean delivery, based on estimation provider team |
| Need for Need for additional uterotonics | Day of surgery | Administration of uterotonics (beyond standard pitocin) during cesarean |
| Maternal blood transfusion | From day of surgery to postpartum discharge (average 3-4 days) | Transfusion of blood products during or after delivery |
| Postpartum hemorrhage | From day of surgery to postpartum discharge (average 3-4 days) | Incidence of postpartum hemorrhage, defined as EBL \>1000cc |
| Neonatal Hgb/Hct | Day 0-2 of life | Obtained from neonatal heel stick |
| APGAR scores | Day of delivery | Assigned at delivery |
| Need for phototherapy for jaundice | From birth to hospital discharge (average 3-4 days) | Any use of phototherapy |
| Venous cord blood Hgb/Hct | Day of delivery | Obtained from cord blood sample |
Countries
United States
Outcome results
None listed