1Clinique Gynécologique et Obstétricale, Hôpital Aristide Le Dantec, Senegal
2Hôpital Institut d’Hygiène Sociale de Dakar, Senegal
3Ministère de la Santé et de l’Action Sociale du Sénégal, Senegal
4Centre Hospitalier National de Pikine, Senegal
5Unité de Formation et de Recherche (UFR) en Science de la Santé de Thiès, Senegal
6Unité de Formation et de Recherche (UFR) en Science de la Santé de Saint-Louis, Senegal
7Centre de Formation, de Recherche et de Plaidoyer en Santé de la Reproduction (CEFOREP), Senegal
Submission: June 11, 2019; Published: June 19, 2019
*Corresponding author: Doctor Mouhamadou Mansour NIANG, Clinique Gynécologique et Obstétricale, Hôpital Aristide Le Dantec, Senegal
How to cite this article: Niang M, Mbodj A, Dieme F, Gassama O, Diouf A, et al. The Intra-Uterin Balloon with Reduced Cost: An Innovative, Safe and Adapted Solution for the Management of Immediate Post-Partum Hemorrhage (Hppi) by Uterine Atony in Low Resources Countries. J Gynecol Women’s Health. 2019: 15(4): 555916. DOI: 10.19080/JGWH.2019.15.555916
Keywords: Postpartum hemorrhage; Maternal mortality; Neonatal care; Hypogastric artery ligation; Surgical treatments; World Health Organization; Small woolen threads; Uterine atony; Obstetric; Gynecologist
Abbrevations: IPPH: Immediate Postpartum Hemorrhage; WHO: World Health Organization; AMTSL: Active Management of the Third Stage of Delivery.
Immediate postpartum hemorrhage (IPPH) is the leading cause of maternal mortality and morbidity in developing countries, with nearly 130,000 deaths each year and 2.6 million complications worldwide [1-3]. In Senegal, according to an assessment of emergency obstetric and neonatal care carried out between July 2012 and June 2013, the maternal mortality ratio was 222.9 per 100,000 live births, and haemorrhage was a direct cause of maternal death in 44,2% (SONU survey). In our limited resources countries, particularly in Senegal, available therapeutic means are: uterotonics (oxytocin, misoprostol), conservative surgery (triple arterial ligation, uterine artery ligation, hypogastric artery ligation, B- Lynch and Cho) and hysterectomy of hemostasis. These surgical treatments are not feasible by all health providers and are not available at the peripheral level (non-surgical health center, health post and health hut) where the majority of deliveries take place. Then, it is necessary to promote other
therapeutic means better suited to our realities. To do this, the World Health Organization (WHO) recommends the use of the intra-uterine balloon as a second-line treatment for postpartum haemorrhage by uterine atony after failure of medical treatment and before resorting to surgery. However, due to their high cost, these devices are not accessible to developing countries. Over the past 5 years, a team at the Massachusetts General Hospital in the United States has designed and implemented a low-cost balloon (less than USD 5 or 3000 XOF) composing by two condoms, a catheter 24 gauge with an anti-reflux system, a 60ml syringe and two small woolen threads. In collaboration with them, since March 2014, we have initiated a multicenter national study to evaluate the efficacy and safety of the low-cost intra-uterine balloon in the management of immediate postpartum hemorrhage by persistent uterine atony after medical treatment.
Health structures had to meet the following criteria:
a) be equipped with a maternity level 2 or 3 with a functional
b) have a protocol for the management of HPPI that did
not previously include the intra-uterine balloon,
c) express an interest in the use of the intra-uterine balloon,
d) identify a focal point for the structure that will participate
in the training of trainers and be responsible for upgrading
the rest of the medical staff and midwives and collecting
e) be located in the regional capital.
Thirteen (13) health structures had met the above criteria
and were selected: the regional hospitals of Thiès, Ziguinchor,
Kaolack, Saint Louis, Youssou Mbargane Diop hospital in Rufisque,
Grand Yoff General Hospital, Nabil Choucair Health Center,
Philippe Maguilène Senghor Health Center, Abass Ndao Hospital,
Ouakam Military Hospital, Pikine Hospital, Roi Baudouin
Hospital in Guédiawaye and Principal Hospital in Dakar.
In order to accompany the introduction and the implementation
of the intra-uterine balloon in Senegal, a four-hour practical
training session for trainers was organized in March 2014 in collaboration
with the team Of the General Hospital of Massachusetts.
For each health center selected, an obstetric gynecologist
and two midwives were trained. They were asked to use the intra-
uterine balloon for the management of IPPH by uterine atony
after failure of the preventive measures (active management of
the third stage of delivery: AMTSL) and the medical treatment
in force at Senegal (bladder sampling, uterine massage, sutures
of perineal or cervical lesions, administration of uterotonics,
artificial delivery and uterine revision) and prior to surgery. At
the end of the training, 60 kits of intra-uterine balloon were distributed
at a rate of 5 per health centers. Each kit contains two
condoms, a 24 gauge catheter with an anti-reflux system, a 60ml
syringe, two small woolen threads, an illustrated checklist and a
data collection sheet.
The condom is attached to the end of the catheter by the two
small threads and the catheter-condom assembly, guided by the
index and the medius, is introduced into the uterine cavity. Using
the syringe, the balloon is filled with clean water. On average 300
to 500ml are sufficient. If the hemorrhage stops, the balloon is
left in place for 6 to 24 hours, on average 8 hours. A prophylactic
dose of a broad-spectrum antibiotic (amoxicillin-clavulanic
acid at 1g every 8 hours over 48 hours) and analgesic treatment
(paracetamol perfusion at 1g every 12 hours until the balloon’s
withdrawal) were recommended. When the patient is hemodynamically
stable, the balloon is deflated with the syringe and removed
from the uterine cavity while at the same time waiting
for a resumption of bleeding. If bleeding resumes, the balloon is
inflated again and left in place for 36 hours.
The study involved patients with immediate postpartum haemorrhage
due to uterine atony, which persisted despite medical
treatment in Senegal. The criteria for non-inclusion were allergy
to latex and IPPH caused by other than uterine atony.
It was made using a data collection sheet containing the following
items: the kit’s follow-up number, the name of the health
structure, the age, the parity and the number of live children of
the patient, The date and time of delivery, the treatment received
before and after the use of the balloon, the patient’s state of consciousness
at the time of balloon insertion, the need for maternal
resuscitation, transfusion or hysterectomy of hemostasis, the
efficacy and safety of the intra-uterine balloon and the patient’s
The plug was filled immediately after the use of the intra-
uterine balloon and sent as soon as possible to the study coordinator.
The latter gives to the focal point of the health structure
another kit to replace the one that has been already used.
At the end of the training session, 36 health providers were
competent to use the intra-uterine balloon in the management
of IPPH by uterine atony. Twelve gynecologists-obstetricians and
24 midwives from 12 health structures (level 2 or 3 hospitals)
were chosen to participate in the study. Between March 2014 and
August 2016, the intra-uterine balloon was used at least once in
10 of the 13 health structures. A total of 50 intra-uterine balloon
kits were used and distributed as follows in decreasing order:
a) Pikine hospital (13/50),
b) Health center Nabil Choucair (9/50),
c) Thiès regional hospital (7/50),
d) Ouakam military hospital (5/50)
e) Ziguinchor Regional Hospital (4/50),
f) Saint Louis Regional Hospital (3/50)
g) Kaolack regional hospital (3/50),
h) Youssou Mbargane Diop Hospital of Rufisque (2/50),
i) General Hospital of Grand Yoff (2/50),
j) Roi Baudouin hospital of Guédiawaye (1/50),
Among the 50 uses of intra-uterine balloon, we registered 45
Patients were aged between 15 and 44 years with an average
of 27 years. The most represented group was 32 years and over.
Parity ranged from 1 to 8 with an average of 2. The number of
live children averaged 2. All patients had delivered in a health
structure that was a health center in the majority of cases (34%).
The balloon was inserted by an obstetrician in 26 cases (52%),
only one balloon was performed by a midwife.
Before to balloon insertion, the patients had the following
interventions: uterotonic prophylaxis (100%), uterine massage
(45/50, 90%), uterine revision (45/50, 90%), sutures of perineal
lesions (18/50, 36%), bimanual compression (5/50, 10%),
uterotonic treatment (43/50, 86%). At the time of balloon insertion,
31 patients (62%) had clear consciousness, 13 (26%) were
confused and 6 (12%) were unconscious. Hemodynamically,
there were 15 cases of cardiovascular collapse (30%).
The intra-uterine balloon was used in 16 cases (32%) at level
2 maternity. The delay between delivery and insertion of the intra-
uterine balloon was between 13 minutes and 07 hours with
an average 2 hours 16 minutes. After the intra-uterine balloon’s
insertion, 45 patients (90%) stopped bleeding and a failure occurred
in 5 cases (10%). In case of failure, we noticed in 3 cases
that the bleeding immediately stopped, then restarted within a
median time of 60 minutes; for the other two cases, there was a
persistence of haemorrhage after intrauterine tamponade due to
a malposition of the balloon for one patient. For those patients
for whom the intra-uterine balloon was found to be ineffective,
in the management of delivery hemorrhage, 4 had had a hysterectomy
of hemostasis (9.8%) and one patient had died (2.4%).
In our study, the insertion-withdrawal time of the intra-uterine
balloon varied between 15 minutes and 43 hours with an
average of 13 hours 58 minutes. In the 6 weeks following the delivery
and insertion of the intra-uterine balloon, no patient had
an infection. The discharged patients were systematically on a
curative dose of iron over 3 months. Antibiotic prophylaxis was
also recommended for a minimum of 7 days.
The principle of the tamponade to stop bleeding results from
a play of pressure: the application of an extravascular pressure
superior to the intravascular pressure in a prolonged way makes
possible to seal the vessels and interrupts the bleeding . Bakri
was the first to mention it in the treatment of haemorrhages
secondary to a placenta praevia or accreta during a caesarean
section  by the use of several Foley probes inserted together
in the uterine cavity. The main restriction to the use of the Foley
probe was its filling volume limited to 150mL . We chose the
balloon described above which has a greater capacity than the
Foley probe and whose cost is more accessible for our limited
In our study, 50 immediate postpartum hemorrhage (IPPH)
due to uterine atony were handled with the low-cost intra-uterine
balloon. Despite the precarious hemodynamic status of the
patients (15 cases of cardiovascular collapse including 13 with
consciousness disorders) reflecting the severity of the IPPH, this
treatment stopped bleeding 45 times out of 50 (90%). These results
are encouraging and show the efficacy of the intra-uterine
balloon in the management of IPPH. Several authors have reported
results similar to ours [4, 6- 8]. Indeed, in the Condous series
of 16 patients with persistent bleeding, Sengstaken-Blakemore
catheterization was effective in 14 of them, only 2 patients required
a surgical procedure because of a placenta Praevia .
The main advantage of the balloon presented in the study is its
cost (5 USD) which is far cheaper (40 times) than the Sengstaken-
Blakemore probe (220 USD) for an equivalent efficiency.
However, we performed four hysterectomies of haemostasis
(%). One of them followed two unsuccessful attempts to use the
balloon. The device was low located in the uterine cavity and as
soon as it was filled it was externalized to find itself in the vagina.
This was obviously a technical problem, showing the real need of
training in balloon use. Therefore, in collaboration with the Ministry
of Health and Social Action of Senegal, our objective should
be to empower all providers who practice childbirth at all levels
of the health pyramid for the use of this tool.
Only one patient was evacuated after the insertion of the intrauterine
balloon It was due to an acute renal anuric insufficiency.
It has well evolved with a normalization of the renal function
after a stay in intensive care and sessions of hemodialysis. This
low rate of evacuation after use of the balloon (3.3%) makes us
think that it is a therapeutic mean adapted to the remote and under
medicalized areas of the country. Indeed, it could help to reduce
the rate of evacuation of these peripheral structures which
often, after the failure of the medical treatment, send patients to
the higher level structure where the surgery can be performed.
In our study, the lethality was 2.4%; it was lower than the
2013 SONU survey’s result which was 4.1% for the lethality due to postpartum hemorrhage . In several studies about the intra-
uterine tamponade balloon, the lethality was zero; but it was
a study with a small number of patients that did not allow the
real assessment of lethality when intrauterine tamponade was
introduced as a second line treatment in case of IPPH by uterine
atony [10-13]. These lethality and morbidity rates in our serie
reflect the efficacy and safety of the intra-uterine balloon when
used by trained practicians. Also, there were no cases of endometritis.
This is a reflection of the innocuousness of the intra-uterine
balloon when used in combination with effective antibiotic
Almost all intra-uterine balloon (98%) were performed by
medical staff (residents and gynecologist-obstetricians), and
one (2%) by a midwife from a regional hospital. This was a limit
in our study but could be explained by the fact that our study
was carried out in reference hospitals where care is provided 24
hours a day by a resident or an obstetric gynecologist. However,
this practice should be extended to midwives who perform the
majority of deliveries and who generally practice in peripheral
areas where surgery is often unavailable. In the Burke et al. study,
53% of intra-uterine balloon insertions were performed by midwives
and the overall success rate was 95% . This proves the
feasibility of intra-uterine balloon insertion by midwives.
The low cost intra-uterine balloon is an affordable, effective
and safe method for the management of persistent IPPH after
medical treatment in limited resource countries such as Senegal.
However, a larger scale study including all health providers (gynecologist-
obstetricians, residents and midwives) and all levels
of the health pyramid would be necessary to assess the feasibility
of this intervention throughout the Senegalese territory.