The Effect of Placental Cord Drainage on Postpartum Blood Loss

Study Overview
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Brief Summary
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To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery

Detailed Description
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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

Official Title
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The Effect of Placental Cord Drainage on Postpartum Blood Loss

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Procedure: Placental Blood Drainage
* Procedure: Placenta Blood Not Drained


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placenta Blood Drained Placenta Blood Not Drained
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placenta Blood Drained<br>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<br>* 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.<br>|
| Active Comparator: Placenta Blood Not Drained<br>This is the control group. The cord will not be unclamped. | Procedure: Placenta Blood Not Drained<br>* Placenta Blood Not Drained<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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