Postpartum Hemorrhage
Conditions
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
Interventions
PROCEDUREPlacental 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.
PROCEDUREPlacenta Blood Not Drained
Placenta Blood Not Drained
Sponsors
Sponsor GmbH
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Placenta Blood Drained Placenta Blood Not Drained
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Blood Loss | Through delivery completion, on average 30 minutes | Total Volume in Underbuttocks Drape - Initial Volume in Drape (amniotic fluid etc) + blood in laparotomy sponges |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retained Placenta | 30 minutes after delivery | Placenta not delivered \> 30 minutes |
| Postpartum Hemorrhage | 30 minutes to 1 hour after delivery | Blood Loss Greater than 1000cc |
| Blood Loss > 500 cc | 30 minutes to 1 hour after delivery | Greater than average postpartum blood loss |
| Duration of Third Stage of Labor | On average 30 minutes | After neonatal delivery to delivery of the placenta |
| Percent Drop in HgB and Hct | Up to 48 hours following delivery | Lab draw following delivery |
| Additional Uterotonic Administration | 30 minutes to 1 hour following delivery | Medications administered to stop postpartum bleeding |
| Endometritis | Up to 12 weeks following delivery | Infection of myometrium of uterus |
| Need for Blood Transfusion | Up to 24 hours postpartum | In event of HgB \<7 or active bleeding |
Countries
United States
Outcome results
None listed