NCT00892229

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
Last Updated

May 4, 2009

Status Verified

May 1, 2009

Enrollment Period

10 months

First QC Date

May 1, 2009

Last Update Submit

May 1, 2009

Conditions

Missed Abortion

Keywords

First trimester missed abortionMisoprostolbuccalvaginalcervical ripeningfirst trimestermissed abortion

Outcome Measures

Primary Outcomes (1)

  • 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.)

    March 2007 to March 2008

Secondary Outcomes (1)

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

    March 2007 to March 2008

Study Arms (3)

Buccal Misoprostol

ACTIVE COMPARATOR

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

Drug: Misoprostol (given buccally)

Vaginal Misoprostol

ACTIVE COMPARATOR

Group two: 5 patients received vaginal misoprostol

Drug: Misoprostol (given vaginally)

Buccal and Vaginal Misoprostol

ACTIVE COMPARATOR

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.

Drug: Misoprostol (given buccally)Drug: Misoprostol (given vaginally)

Interventions

Misoprostol (given buccally)DRUG

400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)

Also known as: serial number 022-00
Buccal MisoprostolBuccal and Vaginal Misoprostol
Misoprostol (given vaginally)DRUG

400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)

Also known as: serial number 022-00
Buccal and Vaginal MisoprostolVaginal Misoprostol

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • first trimester missed abortion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iraqi Medical Specialization

Risafa, Baghdad Governorate, 00964, Iraq

Location

MeSH Terms

Conditions

Abortion, Missed

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • BASHAR Y F HANOOSHI, CABOG

    IRAQI MEDICAL SPECIALIZATION/IRAQ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 4, 2009

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

May 4, 2009

Record last verified: 2009-05

Locations

IR(1)