A new minimally invasive

treatment for cesarean scar

pregnancy and cervical
pregnancy
Ilan E. Timor-Tritsch, MD; Ana Monteagudo, MD; Terri-Ann Bennett, MD;
Christine Foley, MD; Joanne Ramos, RDMS; Andrea Kaelin Agten, MD

Zarieh Dawn L. Novela, MD

Post Graduate Intern – AMCM 2016
 OBJECTIVE:
To introduce the use of a
double-balloon catheter as a
novel, minimally invasive
treatment in patients with
cesarean scar and cervical
pregnancies
to terminate the pregnancy
to prevent bleeding by
compressing the blood
supply of the gestational sac.
INTRODUCTION

Cesarean Scar Pregnancy

 subsequent pregnancy implants on the scar
area or in the dehiscence (niche) left
behind by the hysterotomy
INTRODUCTION

Cesarean Scar Pregnancy

 Successful
treatment:
laparotomy,
hysterotomic
resection and
uterine scar
dehiscence repair
 The real
incidence of
cesarean scar
pregnancy is
unknown
 1 in 1800 to 1 in 2500
cases of previous
cesarean deliveries.
INTRODUCTION

Cesarean Scar Pregnancy

 Incidence in Philippines
INTRODUCTION

Cesarean Scar Pregnancy

 Review: 1972-2011(751cases)
204
Publications

176 articles:
1st trimester
Cesarean scar
pregnancy

49 articles:
2nd trimester
Placenta accreta
INTRODUCTION

Cesarean Scar Pregnancy

 Review: 1972-2011(751cases)

Misdiagnosis
44.1%
751 cases reported
complications Treatment

BLEEDING
INTRODUCTION

Cesarean Scar Pregnancy

Hypothesis
#1 By using a double-balloon catheter, inflating
the upper one in the uterine cavity to serve as an
anchor would prevent expulsion of the lower
pressure balloon to provide tamponade
Hypothesis
#2 The lower balloon exerted upon the gestational
sac and its blood supply would be sufficient to
stop embryonic cardiac activity while at the
same time prevent bleeding
Materials and Methodsem

Retrospective case series

 Patients diagnosed with cesarean scar
pregnancy or cervical pregnancy referred to
New York University Langone Medical Center
 Inclusion criteria
 6 – 8 weeks AOG
 Embryonic/fetal heart activity
 Desire for termination of pregnancy
 Signed informed consent
Materials and Methods
Preliminary measurements
of the inflated double
balloon catheter

 in vitro
experiments were
performed
 Upper balloon:
≤ 30ml
 Lower balloon:
≤ 20ml
Materials and Methods
Placing of Double-balloon
 Pain meds
 2hrs prior to procedure
 Continued as needed
 Patient placed in lithotomy position
 Vulva and vagina were prepped
 Speculum was inserted and exposed cervix
was cleaned with betadine
 Paracervical block (1% lidocaine)
 Followed by Hegar #7 to facilitate catheter placement
Materials and Methods
Placing of Double-balloon
 Uterus is imaged by TAS
probe
 Insertion of Double
balloon catheter into
uterine cavity
Materials and Methods
Placing of Double-balloon
 Upper balloon inflated
with 10ml sterile saline
 Speculum was removed
and replaced by TVS
probe
 Lower balloon positioned
adjacent to GS
Materials and Methods
Placing of Double-balloon
 Lower balloon inflated
with sterile saline
 Until GS is flattened
VIDEO
Materials and Methods
 Uterus is rescanned after 1hr
 No heart activity + no bleeding
 Patient is discharged

 Follow up after 2-3 d for evaluation and removal

Materials and Methods
At return visit
 Lower balloon is first deflated under TVS
control
 No heart activity + no bleeding
 1 hr observation, then rescanned
 If no local bleeding = upper balloon is deflated
and observed for 30min
 If NO BLEEDING, catheter is removed and pt is
discharged
Materials and Methods
Follow up Evaluation and Outcome
 Weekly ultrasound
 Until area of sac demonstrated diminished
vascularity and until GS volume became
smaller
 Weekly HCG
 Birth control (6 mos)
Results
3 cervical pregnancy
7 cesarean scar pregnancy

Median Median upper Balloon kept in

gestational age: balloon volume: place:
6 6/7 wks 24 ml saline 3 days
(6 3/7 – 7 4/7 wks) (10-30 ml) (1-5 days)

Median Median lower

gestational sac balloon volume:
volume: 15 ml
8.9 ml (8-21 ml)
(2.5-25.8 ml)
Results
3 cervical pregnancy
7 cesarean scar pregnancy

Median HCG at Median time for

insertion of HCG to return to
balloon: NP levels:
29,475 mIU/ml 49days
(2488-64,700 mIU/ml) (28-97 days)
Results
 Minimal amount of spotting and bleeding
 1-2 days after treatment

 Placement of balloons were tolerated

 Pain at inflation of lower balloon (decreased)

 2 ER consults
 Lower abdominal cramps (catheter in place for 2 days)

 Cause of pain – balloon passing and dilating the cervix

 Once balloon were expelled – pain stopped

 No excess bleeding and no embryonic heart activity

 Discharged
Results
Evaluation of double-balloon treatment method
 All patients reported lower abdominal
pressure at inflation phase of catheter
 Lower balloon inflation
 Oral ibuprofen 2hrs prior to the procedure
Results
Evaluation of double-balloon treatment method
 Upper anchor balloon kept
the catheter in place
 providing adequate hemostasis
 Embryonic heartbeats were
stopped (by 1-2hr UTZ) and
no significant bleeding
occurred
Comment/ Discussion
Cesarean scar
pregnancy is
a dangerous
entity,
regardless of
the treatment
chosen.
Comment/ Discussion
Cesarean scar pregnancy:
TO CONTINUE or TO TERMINATE?
Comment/ Discussion
Cesarean scar pregnancy:
TO CONTINUE or TO TERMINATE?
Comment/ Discussion
Rationale of using a double-balloon method in CSP and CP
 Treating obstetrical
hemorrhage by means of
tamponing is well established
 Inflatable balloons
 Inflating with saline → pressure on
bv → hemostasis
Comment/ Discussion
Rationale of using a double-balloon method in CSP and CP
Comment/ Discussion
Rationale of using a double-balloon method in CSP and CP
Comment/ Discussion
How long should the catheter be left in place?
 Low abdominal cramps caused by catheter.
Implications..
 The anchoring balloon was too small to prevent
expulsion
 If patient signals severe pain, catheter have to be
deflated or removed
 Further clinical trials
 adequate and minimum time to keep catheters in
place
 effective fluid volume in the balloons
Comment/ Discussion
Strength and weakness of the study
Strength Weakness
 It is an office-based  Low number of
procedure and all patients treated
patients had the Possible rare
desired positive

complications were not
outcomes investigated
 relatively widely  Length of time for the
available expertise of catheter to be kept in
placing cervical
ripening double place and optimal
balloons inflation volume
Conclusion
The double balloon
is a successful,
minimally invasive
and well-tolerated
single treatment
for cervical
pregnancy and
cesarean scar
pregnancy
Conclusion
4 main advantages:
 it effectively stops
embryonic cardiac
activity
 prevents bleeding
complications
 does not require any
additional invasive
therapies
 familiar to ob-gynes who
use the same cervical
ripening catheters for
labor induction.
 Critical
Appraisal
 Did the overview address a focused clinical
question?
 Is the research method (study design)
appropriate for answering the research
question?
 Are both the setting and the subjects
representative with regard to the population to
which the findings will be referred?
 Is the researcher’s perspective clearly
described and taken into account?
 Are the methods for collecting data clearly
described?
 Was the analysis repeated by more than one
researcher to ensure reliability?
 Are the results credible, and if so, are they
relevant for practice?
 Are the conclusions drawn justified by the
results?
 Are the findings of the study transferable to
other settings?
 End of report,
Thank you.