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

Phase 2

Completed

• Conditions: Missed Abortion
• Interventions: Drug: Misoprostol (given buccally); Drug: Misoprostol (given vaginally)

• Registration Number: NCT00892229
• Lead Sponsor: Hawler Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-01
• Study Completion: 2008-03
• Status Verified: 2009-05
• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-01
• Last Update Submitted: 2009-05-01
• Study First Posted: 2009-05-04
• Last Update Posted: 2009-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buccal and Vaginal Misoprostol	Misoprostol (given buccally)	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.
Buccal Misoprostol	Misoprostol (given buccally)	Group one: 50 patients with first trimester missed abortion received buccal misoprostol
Vaginal Misoprostol	Misoprostol (given vaginally)	Group two: 5 patients received vaginal misoprostol
Buccal and Vaginal Misoprostol	Misoprostol (given vaginally)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The secondary objectives are to compare the side effects and acceptability by the subjects.	March 2007 to March 2008

Trial Locations

Locations (1)

Iraqi Medical Specialization; 🇮🇶 Risafa, Baghdad, Iraq