NCT01508143

Brief Summary

The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 2, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

January 9, 2012

Last Update Submit

September 30, 2012

Conditions

Termination

Keywords

AbortionPregnancyTerminationMisoprostol

Outcome Measures

Primary Outcomes (1)

  • Abortion

    After 48 hours after treatment each patient is assessed for abortion. Patients are devided into three groups including complete, partial or no abortion.

    48 hours after treatment

Secondary Outcomes (3)

  • Duration of abortion

    Form the begining of treatment to complete abortion

  • Adverse Effects

    48 hours after treatment

  • Need for surgery

    48 hours after treatment

Study Arms (2)

400 microgram misoprostol

EXPERIMENTAL

400 micrograms misoprostol each 6 hours for 8 dose

Drug: Misoprostol 400 micrograms

800 micrograms misoprostol

ACTIVE COMPARATOR

800 micrograms misoprostol each 12 hours for 4 dose

Drug: Misoprostol 800 micrograms

Interventions

Misoprostol 400 microgramsDRUG

Misoprostol 400 micrograms each 6 hours for 8 dose

Also known as: Cytotec
400 microgram misoprostol
Misoprostol 800 microgramsDRUG

Misoprostol 800 micrograms each 12 hours for 4 doses

Also known as: Cytotec
800 micrograms misoprostol

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All women who were candidates for early pregnancy termination because of fetal death or other medical conditions
  • Before 14th week of gestation calculated according LMP or first trimester sonography

You may not qualify if:

  • Chorioamnionitis
  • Hypersensitivity to prosstaglandins
  • Past medical history of cardiovascular, kidney or liver or lung diseases
  • Positive history for uterus pathologies
  • suspicious to extra-uterus pregnancy
  • sign and symptoms of uterus infection
  • Molar pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, 097145-3388, Iran

Location

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 11, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 2, 2012

Record last verified: 2012-09

Locations

IR(1)