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CompletedNCT01508143Updated Oct 2, 2012

Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination

An interventional study of Misoprostol 400 micrograms and Misoprostol 800 micrograms in Termination, sponsored by Hormozgan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to female participants. Per ClinicalTrials.gov, last updated 2012-10-02.

Sponsored by Hormozgan University of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Sex
Female
01

Study summary

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

Read the detailed description

Studies on determining the optimal dosage for misoprostol in pregnancy termination are continuing and still there is no evidence for ideal misoprostol regimen for pregnancy termination. The aim of this study is to compare two misoprostol regimen in pregnancy termination.

02

Conditions studied

  • Termination

Keywords

  • Abortion
  • Pregnancy
  • Termination
  • Misoprostol
03

In context

Lead sponsor

Hormozgan University of Medical Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    400 microgram misoprostol

    400 micrograms misoprostol each 6 hours for 8 dose

    Drug: Misoprostol 400 micrograms

  • Active comparator
    800 micrograms misoprostol

    800 micrograms misoprostol each 12 hours for 4 dose

    Drug: Misoprostol 800 micrograms

Interventions

  • DrugMisoprostol 400 micrograms

    Misoprostol 400 micrograms each 6 hours for 8 dose

    Also known as: Cytotec

  • DrugMisoprostol 800 micrograms

    Misoprostol 800 micrograms each 12 hours for 4 doses

    Also known as: Cytotec

06

What researchers measure

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.

    Time frame: 48 hours after treatment

Secondary outcomes

  1. Duration of abortion

    Duration of abortion Form the begining of treatment to complete abortion

    Time frame: Form the begining of treatment to complete abortion

  2. Adverse Effects

    including nausea, vomiting, fever and chill, diarhea, abdominal cramp, skin rash

    Time frame: 48 hours after treatment

  3. Need for surgery

    Dilatation \& cartage

    Time frame: 48 hours after treatment

07

Study locations

1 site
  • Hormozgan University of Medical Sciences
    Bandar Abbas, Hormozgan 097145-3388, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01508143
Lead sponsor
Hormozgan University of Medical Sciences
Responsible party
Hamidreza Mahboobi (Medical Doctor, Hormozgan University of Medical Sciences) — Principal investigator
First posted
Jan 11, 2012
Start date
Jan 2012
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Oct 2, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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