Every year, 130 million women deliver babies around the world, and an estimated 14 million
(11%) experience postpartum hemorrhage (PPH), recently redefined as a cumulative blood loss
of 1000 ml or more or blood loss associated with signs or symptoms of hypovolemia,
irrespective of the route of delivery. PPH is the leading cause of maternal mortality
worldwide, responsible for 25% of maternal deaths from obstetric causes, with 99% occurring
in low and middle income countries (LMICs). Although PPH has multiple causes, the most common
is uterine atony when the uterus fails to adequately contract after childbirth, accounting
for 70% of all PPH. Active management of the third stage of labor, consisting of
administering prophylactic uterotonics, controlled cord traction, and uterine massage after
delivery, reduces the incidence of PPH by approximately 66%. These conservative measures
facilitate the normal postpartum tetanic myometrial contractions that constrict the placental
bed vasculature. When PPH occurs in spite of these preventive measures, therapeutic options
include additional uterotonics (medical), uterine tamponade (mechanical) and surgical
interventions (vascular ligation, uterine compression sutures and hysterectomy).
Uterine balloon tamponade is often the second line therapy when medical management is
unsuccessful and is achieved with inflatable devices inserted into the uterus to exert
outward compression on the uterine walls. Despite its widespread use, its mechanism is
counterintuitive to the physiologic uterine contraction that occurs after delivery to control
bleeding. Its use is further limited by prolonged treatment times (typically 12-24 hours),
urinary tract occlusion, and inability to reveal any continuing bleeding. Low-cost options
most commonly condom catheters are used in LMICs, but two recent randomized trials showed no
improvement in maternal outcomes and possible harm. Thus, there is an urgent need for
effective and safe treatment options to reduce the burden of PPH particularly in LMICs.
The Jada® System (Alydia Health, Menlo Park, CA, USA) is a novel U.S. FDA-cleared
intrauterine vacuum-induced hemorrhage-control device specifically designed for rapid
treatment of PPH. It mimics postpartum physiology by applying low-level intrauterine negative
pressure to facilitate uterine compressive forces for constriction of blood vessels to
achieve hemostasis. Preliminary data from two studies have shown promising results. The
device was first evaluated in a feasibility case series (n=10) in Indonesia and showed rapid
treatment of abnormal postpartum uterine bleeding.6 The second larger study, a multicenter
single-arm trial (n=106) in the United States, confirmed quick and definitive control of
bleeding in 94% of cases within a median time of 3 minutes and few adverse events. While
promising, these data are limited by lack of control groups, possible selection bias and the
modest sample sizes which preclude definitive conclusions regarding the relative
effectiveness and safety of the Jada® System.
We propose the first, definitive, randomized control trial (N=424) to test the hypothesis
that the Jada® System is effective, safe and cost-effective in treating PPH, compared to
standard care. A multidisciplinary team of investigators with expertise in obstetrics, global
health and clinical trials will enroll 424 women in two high volume obstetric units in Ghana,
a LMIC with high PPH burden, to pursue the following specific aims:
Primary Aim: Evaluate the effectiveness of the Jada® System, compared to standard care, in
treating PPH.
Secondary Aim 1: Assess the safety of the Jada® System, compared to standard care, in
treating PPH.
Secondary Aim 2: Estimate the cost-effectiveness of the Jada® System, compared to standard
care, in treating PPH.