Clinical trial NCT05610345: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Sponsor GmbH
First posted: 2022-11-09
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placenta Blood Drained Placenta Blood Not Drained
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Qualitative Blood Loss
timeFrame: Through delivery completion, on average 30 minutes
Secondary outcomes:
measure: Duration of Third Stage of Labor
timeFrame: On average 30 minutes
measure: Retained Placenta
timeFrame: 30 minutes after delivery
measure: Postpartum Hemorrhage
timeFrame: 30 minutes to 1 hour after delivery
measure: Blood Loss > 500 cc
timeFrame: 30 minutes to 1 hour after delivery
measure: Need for Blood Transfusion
timeFrame: Up to 24 hours postpartum
measure: Percent Drop in HgB and Hct
timeFrame: Up to 48 hours following delivery
measure: Additional Uterotonic Administration
timeFrame: 30 minutes to 1 hour following delivery
measure: Endometritis
timeFrame: Up to 12 weeks following delivery
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Regional One Health
state: Tennessee
Study officials:
affiliation: Regional One Health
name: John Schorge, MD, FACS
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.