Grand Rounds

A New Intrauterine Device to Treat Postpartum Hemorrhage

BACKGROUND AND PURPOSE:

A new device has been developed that can apply low-level intrauterine vacuum (70–90 mm Hg) to facilitate uterine contractions and constrict blood vessels
D’Alton et al. (Obstetrics & Gynecology, 2020) evaluated the effectiveness and safety of this device to treat PPH

Multicenter, prospective, single-arm treatment study
Participants
- Delivery ≥34 weeks
- Normal uterine anatomy
- Atony-related blood loss
  - Vaginal delivery: 500 to 1,500 mL
  - Cesarean: 1,000–1,500 mL
- Unresponsive to uterotonics and uterine massage
Intervention
- Intrauterine vacuum device
Primary effectiveness outcome
- Proportion of participants treated with intrauterine vacuum device that did not require escalating interventions
Primary endpoints
- Device-related adverse events
  - Incidence | Severity | Seriousness
Secondary endpoints
- Time to bleeding control
- Rate of transfusion
- Device usability scored by each practitioner

106 participants
Successful treatment: 94% (95% CI, 88 to 98%)
- Median time to control: 3 minutes (IQR 2.0 to 5.0 min)
Adverse events related to the device
- 8 events
- All were outlined as risks in the study
- All were resolved without serious clinical sequelae
- Adverse events included
  - Endometritis | Disruption of vaginal laceration repair | Presumed endometritis | Bacterial vaginosis | Vaginal candidiasis
Transfusions
- 1 to 3 units: 33%
- ≥4 units: 5%
Ease of use
- Reported ease of use: 98%
- Reported would recommend it: 97%

Among successfully treated patients, control of abnormal bleeding was quickly established
The authors state that while an RCT should be considered in the future, the device

…offers a therapeutic modality that may be considered early in the treatment of abnormal postpartum uterine bleeding or postpartum hemorrhage

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