A Prospective Study of Misoprostol Administration in Asymptomatic Patients With Pregnancies of Unknown Location (amalis)

Sheba Medical Center

Status: Unknown

Conditions: Pregnancies of Unknown Location (PUL)

Treatments: Other: Placebo; Drug: CYTOTEC

Study type: Interventional

Funder types: Other

Identifiers

NCT02581761

SHEBA-14-1327-IA-CTIL

Details and patient eligibility

About

A randomized prospective double blind study of misoprostol administration in asymptomatic patients with pregnancies of unknown location.

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• hemodynamically stable women >18 years old with a PUL with abnormal plateauing serum βHCG trend

Exclusion criteria

• Hemoglobin<10

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Cytotec treatment group

Experimental group

Description:

patient with pregnancy of unkown location will receive cytotec 800 mcg per vaginal

Treatment:

Drug: CYTOTEC

Placebo treatment group

Placebo Comparator group

Description:

patient with pregnancy of unkown location will receive suppository which contain Whitepsol H-15 with no active material (Cytotec).

Treatment:

Other: Placebo