The Effect of Placental Cord Drainage on Postpartum Blood Loss

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Procedure: Placental Blood Drainage; Procedure: Placenta Blood Not Drained

• Registration Number: NCT05610345
• Lead Sponsor: University of Tennessee

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 Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-09
• Study Start: 2022-11-12
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placenta Blood Drained	Placental Blood Drainage	Immediately after delayed cord clamping and cutting of the umbilical cord, the cord will be unclamped and blood with be drained until cessation of flow.
Placenta Blood Not Drained	Placenta Blood Not Drained	This is the control group. The cord will not be unclamped.

Primary Outcome Measures

Name	Time	Method
Qualitative Blood Loss	Through delivery completion, on average 30 minutes	Total Volume in Underbuttocks Drape - Initial Volume in Drape (amniotic fluid etc) + blood in laparotomy sponges

Secondary Outcome Measures

Name	Time	Method
Blood Loss > 500 cc	30 minutes to 1 hour after delivery	Greater than average postpartum blood loss
Need for Blood Transfusion	Up to 24 hours postpartum	In event of HgB \<7 or active bleeding
Duration of Third Stage of Labor	On average 30 minutes	After neonatal delivery to delivery of the placenta
Postpartum Hemorrhage	30 minutes to 1 hour after delivery	Blood Loss Greater than 1000cc
Retained Placenta	30 minutes after delivery	Placenta not delivered \> 30 minutes
Percent Drop in HgB and Hct	Up to 48 hours following delivery	Lab draw following delivery
Additional Uterotonic Administration	30 minutes to 1 hour following delivery	Medications administered to stop postpartum bleeding
Endometritis	Up to 12 weeks following delivery	Infection of myometrium of uterus

Trial Locations

Locations (1)

Regional One Health; 🇺🇸 Memphis, Tennessee, United States