NCT05610345

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

November 12, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

October 26, 2022

Last Update Submit

February 12, 2024

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Duration of Third Stage of Labor

    On average 30 minutes

  • Retained Placenta

    30 minutes after delivery

  • Postpartum Hemorrhage

    30 minutes to 1 hour after delivery

  • Blood Loss > 500 cc

    30 minutes to 1 hour after delivery

  • Need for Blood Transfusion

    Up to 24 hours postpartum

  • +3 more secondary outcomes

Study Arms (2)

Placenta Blood Drained

EXPERIMENTAL

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

Placenta Blood Not Drained

ACTIVE COMPARATOR

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

Procedure: Placenta Blood Not Drained

Interventions

Placental Blood DrainagePROCEDURE

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.

Placenta Blood Drained
Placenta Blood Not DrainedPROCEDURE

Placenta Blood Not Drained

Placenta Blood Not Drained

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional One Health

Memphis, Tennessee, 38103, United States

Location

Related Publications (5)

  • Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.

    PMID: 28937571BACKGROUND

  • WHO recommendations on maternal health: guidelines approved by the WHO Guidelines Review Committee [Internet]. Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK615100/

    PMID: 40455892BACKGROUND

  • 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.

    PMID: 27651611RESULT

  • 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.

    PMID: 28765609RESULT

  • 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.

    PMID: 29718920RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Schorge, MD, FACS

    Regional One Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Placenta Blood Drained Placenta Blood Not Drained
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 9, 2022

Study Start

November 12, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)