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

October 20, 2015 updated by: Dr. Isa Amal, Sheba Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Hemoglobin<10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cytotec treatment group
patient with pregnancy of unkown location will receive cytotec 800 mcg per vaginal
Drug: CYTOTEC
synthetic prostaglandin E1
Other Names:
  • Misoprostol
Placebo Comparator: Placebo treatment group
patient with pregnancy of unkown location will receive suppository which contain Whitepsol H-15 with no active material (Cytotec).
Other: Placebo
no active material
Other Names:
  • Whitepsol H-15

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: two weeks for each patient
two weeks for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-14-1327-IA-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancies of Unknown Location (PUL)

Clinical Trials on CYTOTEC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe