Faculty
Deena Goffman, MD, FACOG
Dr. Goffman is the Ellen Jacobson Levine and Eugene Jacobson Professor of Women’s Health in Obstetrics and Gynecology and Vice Chair for Quality and Patient Safety at Columbia University Irving Medical Center
Learning Objectives
Upon completion of this activity, participants should be better able to
- Recognize novel opportunities in PPH management
- Understand when and how to place vacuum induced hemorrhage control device
THE CASE
- 30 year old G2P1, at 38w2d undergoing induction of labor
- Medical history significant for chronic hypertension, now with superimposed preeclampsia with severe features on magnesium sulfate for seizure prophylaxis
- Gestational diabetes controlled with diet with estimated fetal weight of 4000 g
- Prior uncomplicated vaginal birth and no other comorbidities
BACKGROUND
Postpartum Hemorrhage
- Remains a leading cause of preventable Severe Maternal Morbidity and mortality
- Definition
- Cumulative blood loss ≥1,000mL or
- Blood loss accompanied by sign/symptoms of hypovolemia within 24 hours following the birth process (includes intrapartum loss) irrespective of mode of delivery
- Critical Point – Cumulative Blood Loss of 500 to 999 mL
- Blood loss between 500 to 999mL in the setting of vaginal birth is not typical
- This finding alone should trigger increased supervision and potential interventions as clinically indicated
- Timely recognition of abnormal bleeding allows for increased surveillance and early, proactive intervention
- While there is always a differential diagnosis for abnormal bleeding, uterine atony is the most common etiology accounting for approximately 80% of PPH cases
TREATMENT
Uterotonic Medications
- Much focus over last 10 years on the need for institution specific stage-based emergency hemorrhage management plans
- Follow a similar framework and outline the steps teams should take in the setting of abnormal bleeding and/or PPH
- Once PPH etiology identified as uterine atony there are only a handful of uterotonic medications available to treat the condition
- Oxytocin | Methergine | Hemabate | Misoprostol (although misoprostol has been deemed a treatment of uncertain usefulness)
- Note: Health history may lead to contraindications for use of uterotonics with the most common being
- Methergine contraindicated in hypertensive disorders
- Hemabate contraindicated in asthma
Non-Uterotonic Medication – TXA
- More recently, an additional non-uterotonic medication, tranexamic acid (TXA) has demonstrated promise as an anti-fibrinolytic
- May assist in achieving hemostasis in the setting of PPH irrespective of etiology
Unresponsive to Medications
- In uterine atony, when medications do not achieve adequate control, additional options include
- Devices
- Surgical techniques
- Interventional radiologic procedures
- We will now turn our attention to a novel device, the JADA System, an FDA cleared intrauterine vacuum-induced hemorrhage control device
JADA SYSTEM
Real-world Use Data (RUBY)
- 800 patients enrolled across 16 US sites
- 66% vaginal births
- 34% cesarean births
- Treatment success
- 92.5% in vaginal births
- 83.7% in cesarean births
- Works better when used earlier with success dropping to <50% when >3L blood loss prior to placement
- No safety events determined to be definitively device-related
- Works quickly with bleeding controlled within 5 minutes
- 73.8% of vaginal births
- 62.2% of cesarean births
- Short indwelling median treatment time
- 3.1 hours for vaginal birth
- 4.6 hours for cesarean birth
Pearls
- Many consider the device the equivalent of a mechanical uterotonic
- The order of the steps matter
- Use a visual aid to help ensure team success
- Ensure uterine atony is the primary etiology for bleeding
- Be prepared to place device expeditiously
- Many use a single dose of antibiotics to cover the manual sweep of the cavity and device use
- If there is ongoing blood loss after vacuum applied, consider alternative etiology for bleeding
Practical Tips for Placement
- Manually remove clot from the uterine cavity
- Remove air from the cervical seal prior to placement
- Compress the uterine loop in your dominant hand
- Guide the loop into the lower uterine segment with the cervical seal positioned at the external os
- Fill the seal with 60 to 120mL sterile fluid
- Turn on and set vacuum source to 80 mmHg +/- 10 mmHg
- Occlude end of tubing to test vacuum
- Connect sterile vacuum tubing to JADA
- Typical to see uterine contraction with prompt cessation of bleeding | Often blood is only visible within the tubing not even making it to the wall canister
- If blood continues to flow begin to consider alternative source for bleeding and make arrangements for additional treatment
- If there is cessation of bleeding, treat for at least 1 hour with tube taped to patient inner thigh
- If the patient requires movement to another location, use portable vacuum
Removal Process
- Verify that bleeding remains controlled
- Ensure that tube remains secured to patient’s inner thigh
- Disconnect vacuum tubing from JADA with vacuum on
- Remove sterile fluid from cervical seal
- Observe for 30 minutes to verify bleeding remains controlled
- Remove device slowly while supporting the uterine fundus
Avoiding Pitfalls
- Ensure that the cavity is empty prior to placement the device will not clear clot
- The patient must be 3cm dilated to allow placement
- Often blood is only visualized in the tubing…this does not mean the device isn’t working
- Ensure that fluid is removed from cervical seal during 30 minute observation prior to device removal
CASE FOLLOW UP
- Patient was at high risk for PPH due to multiple risk factors including
- Macrosomia | Induction of labor | Magnesium sulfate
- Vaginal birth with active management of the third stage of labor including
- Controlled cord traction | Massage and oxytocin initiated with delivery of the anterior shoulder
- Bleeding was noted after delivery of placenta
- Quantitative blood loss (QBL) of 625mL was calculated with ongoing bleeding observed
- PPH cart and kit were at bedside
- Bladder emptied, fundal massage performed and a dose of Hemabate was given with ongoing bleeding | Diagnosis of uterine atony was made
- No lacerations were identified
- The JADA system was called for at a QBL of 764mL
- Bimanual exam was performed
- Clot cleared from uterine cavity
- No retained products of conception were palpated
- JADA was placed with prompt improvement in uterine tone and blood noted in the vacuum tubing without active flow into the wall suction canister
- After 1 hour of treatment
- Bleeding remained controlled and the tube remained secured to patient’s inner thigh
- The vacuum tubing was disconnected from JADA with the vacuum on
- All sterile fluid was removed from the cervical seal
- Bleeding and uterine tone were observed for 30 minutes
- Bleeding remained controlled and the device was removed approximately 90 minutes after initial placement
- The patient was transferred to the postpartum unit with a total cumulative QBL of 879mL, hemodynamically stable and doing well.
Learn More – Primary Sources
Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage
Intrauterine Devices in the Management of Postpartum Hemorrhage
Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device
ACOG Practice Bulletin 183: Postpartum Hemorrhage
ACOG: reVITALize: Obstetrics Data Definitions
Commercial Support
This educational activity is supported by an independent medical educational grant from Organon
Faculty Disclosures
Dr. Goffman reports the following:
Cooper Surgical Obstetrical Safety Council
Organon: Jada Scientific Advisory Board; Research support (to employer) for PEARLE and RUBY studies;
Honoraria for Webinars
NICHD Obstetric Hemorrhage Technical Skills; Maternal Sepsis
FetalEase CRC