The Effect of Placental Cord Drainage on Postpartum Blood Loss

NCT ID: NCT05610345

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-12

Study Completion Date

2023-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placenta Blood Drained Placenta Blood Not Drained
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Placental Blood Drainage

Intervention Type PROCEDURE

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 Not Drained

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

Group Type ACTIVE_COMPARATOR

Placenta Blood Not Drained

Intervention Type PROCEDURE

Placenta Blood Not Drained

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Placenta Blood Not Drained

Placenta Blood Not Drained

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sponsor GmbH

OTHER

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Schorge, MD, FACS

Role: STUDY_CHAIR

Regional One Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Regional One Health

Memphis, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 28937571 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 40455892 (View on PubMed)

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.

Reference Type RESULT
PMID: 27651611 (View on PubMed)

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.

Reference Type RESULT
PMID: 28765609 (View on PubMed)

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.

Reference Type RESULT
PMID: 29718920 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-08299-XP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.