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

NCT ID: NCT02581761

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-03-31

Brief Summary

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

Detailed 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.

Conditions

Pregnancies of Unknown Location (PUL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Cytotec treatment group

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

Group Type: EXPERIMENTAL

CYTOTEC

Intervention Type: DRUG

synthetic prostaglandin E1

Placebo treatment group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

no active material

Interventions

CYTOTEC

synthetic prostaglandin E1

Intervention Type: DRUG

Placebo

no active material

Intervention Type: OTHER

Other Intervention Names

Misoprostol; Whitepsol H-15

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Hemoglobin<10

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Isa Amal

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SHEBA-14-1327-IA-CTIL

Identifier Type: -

Identifier Source: org_study_id