Pregnancies of Unknown Location (PUL) Clinical Trial
Official title:
A Randomized Prospective Double Blind Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location
A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.
A randomized prospective double blind study of misoprostol administration in asymptomatic
patients with pregnancies of unknown location.
The management of asymptomatic patients with pregnancies of unknown location (PUL) remains a
challenge. Determining the location of the pregnancy is the first priority in the evaluation
of these women. Some of these asymptomatic women present with inappropriate raising
beta-human chorionic gonadotropin (βHCG), while others have assurance of pregnancy duration
(e.g. IVF pregnancies) with no sonographic evidence of intra or extra uterine pregnancy.
Most of the PULs are failed intra-uterine pregnancies.
The main concern regarding PUL is the late diagnosis of an ectopic pregnancy (EP). Some
studies report that between 5 and 42% of women seen for US assessment with a positive
pregnancy test have a PUL and only 6-20% will subsequently diagnosed with EP (1). Other
studies report that 94% of PUL will resolve spontaneously, and out of the 6% that did not
spontaneously resolve 68.9 % were finally diagnosed with failed IUP and only 5.6% were
diagnosed with EP (2).
Women with PUL should be evaluated in minimum time, but also with minimal invasiveness.
Management that will resolve such pregnancies in a rapid manner will save time and money and
possibly avoid unnecessary administration of MTX or surgical intervention.
Several protocols have been investigated in order to fasten the diagnosis of PUL. For
example, obtaining serial β-HCG, the first one in the initial presentation, two days later
and seven days later (3). Another protocol suggested endometrial sampling by D&C or
aspiration of uterine continents with Karman cannula and checking the β-HCG after 24 hours
(2).
Purpose: The aim of our study will be to prospectively assess the use of misoprostol in
asymptomatic patients with pregnancies of unknown location(PUL).
The study group will contain hemodynamically stable women >18 years old with a PUL with
abnormal plateauing serum β-HCG trend (increase<53%or decrease <15% in 2 days) < 1000 IU/l
and a pelvic ultrasound unremarkable for an intrauterine pregnancy (IUP) or an ectopic
pregnancy (EP).
Each participant will get Vaginal misoprostol 800 mcg or placebo. Main Outcome Measure(s):
The primary outcome measure will be an uneventful decline of serum β-HCG to an undetectable
level (<2 IU/l) by the initial intervention strategy. Secondary outcome measures will
include additional treatment (e.g. methotrexate (MTX) administration or laparoscopy), side
effects and serum β-HCG clearance time, features of the optimal candidates for treatment by
cytotec.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic