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Completed

NCT Number: NCT05610345

The Effect of Placental Cord Drainage on Postpartum Blood Loss

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

Completed

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Regional One Health

Memphis, Tennessee, 38103, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placental Blood Drainage

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

Procedure

Placenta Blood Not Drained

Primary outcomes

  1. Qualitative Blood Loss

    Time frame: Through delivery completion, on average 30 minutes

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

Secondary outcomes

  1. Duration of Third Stage of Labor

    Time frame: On average 30 minutes

    After neonatal delivery to delivery of the placenta

  2. Retained Placenta

    Time frame: 30 minutes after delivery

    Placenta not delivered > 30 minutes

  3. Postpartum Hemorrhage

    Time frame: 30 minutes to 1 hour after delivery

    Blood Loss Greater than 1000cc

  4. Blood Loss > 500 cc

    Time frame: 30 minutes to 1 hour after delivery

    Greater than average postpartum blood loss

  5. Need for Blood Transfusion

    Time frame: Up to 24 hours postpartum

    In event of HgB <7 or active bleeding

  6. Percent Drop in HgB and Hct

    Time frame: Up to 48 hours following delivery

    Lab draw following delivery

  7. Additional Uterotonic Administration

    Time frame: 30 minutes to 1 hour following delivery

    Medications administered to stop postpartum bleeding

  8. Endometritis

    Time frame: Up to 12 weeks following delivery

    Infection of myometrium of uterus

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • Sponsor GmbH

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2022
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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