The Effect of Placental Cord Drainage on Postpartum Blood Loss

Postpartum Hemorrhage Clinical Trial

Official title:

The Effect of Placental Cord Drainage on Postpartum Blood Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05610345
• Other study ID #: 21-08299-XP
• Status: Completed
• Phase: N/A
• Start date: November 12, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: February 2024
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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.
• Placenta Blood Not Drained
Placenta Blood Not Drained

Locations

Country	Name	City	State
United States	Regional One Health	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	Sponsor GmbH

Country where clinical trial is conducted

United States, 

References & 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. — View 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- — View 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. — View 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.

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. — View Citation

Outcome

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