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

Missed Abortion Clinical Trial

Official title:

Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892229
• Other study ID #: IMS - 1769
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2009
• Last updated: May 1, 2009
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: May 2009
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iraq: Hawler College of Medicine/Iraqi Medical Specialization
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Missed
• Missed Abortion

Intervention

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

Locations

Country	Name	City	State
Iraq	Iraqi Medical Specialization	Risafa	Baghdad

Sponsors (2)

Lead Sponsor	Collaborator
Hawler Medical University	NEGATIVE

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The secondary objectives are to compare the side effects and acceptability by the subjects.		March 2007 to March 2008	Yes