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The Effect of Placental Cord Drainage on Postpartum Blood Loss

Primary Purpose

Postpartum Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placental Blood Drainage
Placenta Blood Not Drained
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Regional One HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Placenta Blood Drained

Placenta Blood Not Drained

Arm Description

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.

This is the control group. The cord will not be unclamped.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2022
Last Updated
February 13, 2023
Sponsor
University of Tennessee
Collaborators
Sponsor GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05610345
Brief Title
The Effect of Placental Cord Drainage on Postpartum Blood Loss
Official Title
The Effect of Placental Cord Drainage on Postpartum Blood Loss
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
Collaborators
Sponsor GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Placenta Blood Drained Placenta Blood Not Drained
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placenta Blood Drained
Arm Type
Experimental
Arm Description
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.
Arm Title
Placenta Blood Not Drained
Arm Type
Active Comparator
Arm Description
This is the control group. The cord will not be unclamped.
Intervention Type
Procedure
Intervention Name(s)
Placental Blood Drainage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placenta Blood Not Drained
Intervention Description
Placenta Blood Not Drained
Primary Outcome Measure Information:
Title
Qualitative Blood Loss
Description
Total Volume in Underbuttocks Drape - Initial Volume in Drape (amniotic fluid etc) + blood in laparotomy sponges
Time Frame
Through delivery completion, on average 30 minutes
Secondary Outcome Measure Information:
Title
Duration of Third Stage of Labor
Description
After neonatal delivery to delivery of the placenta
Time Frame
On average 30 minutes
Title
Retained Placenta
Description
Placenta not delivered > 30 minutes
Time Frame
30 minutes after delivery
Title
Postpartum Hemorrhage
Description
Blood Loss Greater than 1000cc
Time Frame
30 minutes to 1 hour after delivery
Title
Blood Loss > 500 cc
Description
Greater than average postpartum blood loss
Time Frame
30 minutes to 1 hour after delivery
Title
Need for Blood Transfusion
Description
In event of HgB <7 or active bleeding
Time Frame
Up to 24 hours postpartum
Title
Percent Drop in HgB and Hct
Description
Lab draw following delivery
Time Frame
Up to 48 hours following delivery
Title
Additional Uterotonic Administration
Description
Medications administered to stop postpartum bleeding
Time Frame
30 minutes to 1 hour following delivery
Title
Endometritis
Description
Infection of myometrium of uterus
Time Frame
Up to 12 weeks following delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ethelin C Cammock, MD
Phone
6056604360
Email
Ecammock@uthsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Santa Cruz, MD
Phone
901 448 2531
Email
Msantacruz@uthsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Schorge, MD, FACS
Organizational Affiliation
Regional One Health
Official's Role
Study Chair
Facility Information:
Facility Name
Regional One Health
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Schorge, MD, FACS
Phone
901-448-2531
Email
Jschorge@uthsc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28937571
Citation
Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
27651611
Citation
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.
Results Reference
result
PubMed Identifier
28765609
Citation
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.
Results Reference
result
PubMed Identifier
29718920
Citation
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.
Results Reference
result

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The Effect of Placental Cord Drainage on Postpartum Blood Loss

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