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Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil

Primary Purpose

Missed Abortion

Status
Completed
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Misoprostol (given buccally)
Misoprostol (given vaginally)
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missed Abortion focused on measuring First trimester missed abortion, Misoprostol, buccal, vaginal, cervical ripening, first trimester, missed abortion

Eligibility Criteria

19 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • first trimester missed abortion

Exclusion Criteria:

  • history or evidence of disorders that represent contraindication to the use of misoprostol:

    • severe pulmonary diseases
    • congenital or acquired heart diseases
    • glaucoma
    • prolonged use of corticosteroid
    • sickle cell anemia and adrenal insufficiency
    • smokers
    • known hypersensitivity to drugs
    • any evidence of infection
  • patient's refusal to participate in the study
  • patients with abnormal results of investigations
  • patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage
  • patients with complete abortion
  • patients with severe bleeding that required emergency surgical evacuation of the uterus
  • patients with partially dissolved tablets at the site of application in both groups

Sites / Locations

  • Iraqi Medical Specialization

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Buccal Misoprostol

Vaginal Misoprostol

Buccal and Vaginal Misoprostol

Arm Description

Group one: 50 patients with first trimester missed abortion received buccal misoprostol

Group two: 5 patients received vaginal misoprostol

50 primiparous and 50 multiparous women: one hundred patients have been administered the medication buccally (25 primigravida and 25 multigravida), and vaginally (25 primigravida and 25 multigravida), three hours before dilation and curettage. They were admitted to the hospital one day before the surgical evacuation, and preparation of cross matched blood done for all recruited subjects. Each group was randomly allocated (1,3,5,... for the buccal group & 2,4,6,... for the vaginal group) to receive 400 microgram misoprostol.

Outcomes

Primary Outcome Measures

To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.)

Secondary Outcome Measures

The secondary objectives are to compare the side effects and acceptability by the subjects.

Full Information

First Posted
May 1, 2009
Last Updated
May 1, 2009
Sponsor
Hawler Medical University
Collaborators
NEGATIVE
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1. Study Identification

Unique Protocol Identification Number
NCT00892229
Brief Title
Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil
Official Title
Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hawler Medical University
Collaborators
NEGATIVE

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missed Abortion
Keywords
First trimester missed abortion, Misoprostol, buccal, vaginal, cervical ripening, first trimester, missed abortion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buccal Misoprostol
Arm Type
Active Comparator
Arm Description
Group one: 50 patients with first trimester missed abortion received buccal misoprostol
Arm Title
Vaginal Misoprostol
Arm Type
Active Comparator
Arm Description
Group two: 5 patients received vaginal misoprostol
Arm Title
Buccal and Vaginal Misoprostol
Arm Type
Active Comparator
Arm Description
50 primiparous and 50 multiparous women: one hundred patients have been administered the medication buccally (25 primigravida and 25 multigravida), and vaginally (25 primigravida and 25 multigravida), three hours before dilation and curettage. They were admitted to the hospital one day before the surgical evacuation, and preparation of cross matched blood done for all recruited subjects. Each group was randomly allocated (1,3,5,... for the buccal group & 2,4,6,... for the vaginal group) to receive 400 microgram misoprostol.
Intervention Type
Drug
Intervention Name(s)
Misoprostol (given buccally)
Other Intervention Name(s)
serial number 022-00
Intervention Description
400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
Intervention Type
Drug
Intervention Name(s)
Misoprostol (given vaginally)
Other Intervention Name(s)
serial number 022-00
Intervention Description
400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
Primary Outcome Measure Information:
Title
To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.)
Time Frame
March 2007 to March 2008
Secondary Outcome Measure Information:
Title
The secondary objectives are to compare the side effects and acceptability by the subjects.
Time Frame
March 2007 to March 2008

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: first trimester missed abortion Exclusion Criteria: history or evidence of disorders that represent contraindication to the use of misoprostol: severe pulmonary diseases congenital or acquired heart diseases glaucoma prolonged use of corticosteroid sickle cell anemia and adrenal insufficiency smokers known hypersensitivity to drugs any evidence of infection patient's refusal to participate in the study patients with abnormal results of investigations patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage patients with complete abortion patients with severe bleeding that required emergency surgical evacuation of the uterus patients with partially dissolved tablets at the site of application in both groups
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BASHAR Y F HANOOSHI, CABOG
Organizational Affiliation
IRAQI MEDICAL SPECIALIZATION/IRAQ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iraqi Medical Specialization
City
Risafa
State/Province
Baghdad
ZIP/Postal Code
00964
Country
Iraq

12. IPD Sharing Statement

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Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil

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