NCT02581761

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

August 27, 2015

Last Update Submit

October 20, 2015

Conditions

Pregnancies of Unknown Location (PUL)

Keywords

Hemodynamically stable women >18 years oldwith abnormal plateauing serum βHCG

Outcome Measures

Primary Outcomes (1)

  • 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

    two weeks for each patient

Study Arms (2)

Cytotec treatment group

EXPERIMENTAL

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

Drug: CYTOTEC

Placebo treatment group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

CYTOTECDRUG

synthetic prostaglandin E1

Also known as: Misoprostol
Cytotec treatment group
PlaceboOTHER

no active material

Also known as: Whitepsol H-15
Placebo treatment group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hemoglobin\<10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

August 27, 2015

First Posted

October 21, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

March 1, 2018

Last Updated

October 21, 2015

Record last verified: 2015-10