Delayed Cord Clamping at Term Cesarean

Cesarean Delivery Clinical Trial

Official title:

Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150641
• Other study ID #: AAAR2937
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: March 31, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cesarean Delivery
• Delayed Cord Clamping
• Hemorrhage
• Maternal Blood Loss
• Neonatal Health

Intervention

Procedure:
• Umbilical cord clamping
The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal change in hemoglobin on post-operative day #1	Difference in hemoglobin between routine pre-op CBC and a postpartum CBC collected on postoperative day #1, by venipuncture	Baseline to postoperative day #1 (range 1-4 days)
Secondary	Postpartum hemorrhage	Incidence of postpartum hemorrhage, defined as EBL >1000cc	From day of surgery to postpartum discharge (average 3-4 days)
Secondary	Estimated blood loss	Estimated blood loss at cesarean delivery, based on estimation provider team	Day of surgery
Secondary	Need for Need for additional uterotonics	Administration of uterotonics (beyond standard pitocin) during cesarean	Day of surgery
Secondary	Maternal blood transfusion	Transfusion of blood products during or after delivery	From day of surgery to postpartum discharge (average 3-4 days)
Secondary	Venous cord blood Hgb/Hct	Obtained from cord blood sample	Day of delivery
Secondary	Neonatal Hgb/Hct	Obtained from neonatal heel stick	Day 0-2 of life
Secondary	APGAR scores	Assigned at delivery	Day of delivery
Secondary	Need for phototherapy for jaundice	Any use of phototherapy	From birth to hospital discharge (average 3-4 days)