The Effect of Placental Cord Drainage on Postpartum Blood Loss

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

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Procedure: Placental Blood Drainage; Procedure: Placenta Blood Not Drained

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Regional One Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placenta Blood Drained; 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.	Procedure: Placental Blood Drainage; Immediately after vaginal delivery following delayed cord clamping and cutting of the cord, the cord will be unclamped and blood will be drained from the placenta until cessation of flow.
Active Comparator: Placenta Blood Not Drained; This is the control group. The cord will not be unclamped.	Procedure: Placenta Blood Not Drained; Placenta Blood Not Drained

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: Sponsor GmbH
• Investigators: Study Chair: John Schorge, MD, FACS, Regional One Health

Publications and helpful links

General Publications

• Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
• WHO recommendations on maternal health: guidelines approved by the WHO Guidelines Review Committee. Geneva: World Health Organization; 2017 (WHO/MCA/17.10). Licence: CC BY-NC-SA 3.0 IGO.
• Roy P, Sujatha MS, Bhandiwad A, Biswas B, Chatterjee A. Placental Blood Drainage as a Part of Active Management of Third Stage of Labour After Spontaneous Vaginal Delivery. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):242-5. doi: 10.1007/s13224-016-0857-3. Epub 2016 Mar 12.
• Wu HL, Chen XW, Wang P, Wang QM. Effects of placental cord drainage in the third stage of labour: A meta-analysis. Sci Rep. 2017 Aug 1;7(1):7067. doi: 10.1038/s41598-017-07722-7.
• Vasconcelos FB, Katz L, Coutinho I, Lins VL, de Amorim MM. Placental cord drainage in the third stage of labor: Randomized clinical trial. PLoS One. 2018 May 2;13(5):e0195650. doi: 10.1371/journal.pone.0195650. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 21-08299-XP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No