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Clinical Trials/NCT05610345
NCT05610345CompletedNot Applicable

The Effect of Placental Cord Drainage on Postpartum Blood Loss

University of Tennessee2 sites in 1 country71 target enrollmentStarted: November 12, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
71
Locations
2
Primary Endpoint
Qualitative Blood Loss

Study Overview

Brief Summary

To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery

Detailed Description

Postpartum hemorrhage complicates 3% of pregnancies in the United States and is a leading cause of maternal morbidity and mortality. ACOG defines PPH as cumulative blood loss greater than 1000cc; however a blood loss >500cc should be considered abnormal. Primary PPH occurs in the first 24 hours and is largely secondary to uterine agony. ACOG as well as the WHO recommend active management of the third stage of labor to prevent PPH. This includes oxytocin administration, uterine massage, and gentle cord traction. Placental cord drainage (PCD) is the unclamping of the umbilical cord to allow for drainage of the blood from the placenta. It is another technique used to shorten the third stage of labor; however, it has not been well studied

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Singleton Gestation
  • Ages 18-45
  • English Speaking
  • Third Trimester Gestation

Exclusion Criteria

  • Operative Vaginal Delivery
  • Multiple Gestation
  • Cesarean Delivery
  • Episiotomy
  • 3rd or 4th degree laceration
  • Less than the Third Trimester of Pregnancy
  • Chorioamnionitis
  • History of Postpartum Hemorrhage
  • Macrosomic Infant

Outcomes

Primary Outcomes

Qualitative Blood Loss

Time Frame: Through delivery completion, on average 30 minutes

Total Volume in Underbuttocks Drape - Initial Volume in Drape (amniotic fluid etc) + blood in laparotomy sponges

Secondary Outcomes

  • Blood Loss > 500 cc(30 minutes to 1 hour after delivery)
  • Need for Blood Transfusion(Up to 24 hours postpartum)
  • Duration of Third Stage of Labor(On average 30 minutes)
  • Postpartum Hemorrhage(30 minutes to 1 hour after delivery)
  • Retained Placenta(30 minutes after delivery)
  • Percent Drop in HgB and Hct(Up to 48 hours following delivery)
  • Additional Uterotonic Administration(30 minutes to 1 hour following delivery)
  • Endometritis(Up to 12 weeks following delivery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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