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

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

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

Study Overview

• Status: Completed
• Conditions: Missed Abortion
• Intervention / Treatment: Drug: Misoprostol (given buccally); Drug: Misoprostol (given vaginally)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iraq
  • Baghdad
    • Risafa, Baghdad, Iraq, 00964
      • Iraqi Medical Specialization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Buccal Misoprostol; Group one: 50 patients with first trimester missed abortion received buccal misoprostol	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); Other Names: serial number 022-00
Active Comparator: Vaginal Misoprostol; Group two: 5 patients received vaginal misoprostol	Drug: Misoprostol (given vaginally); 400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms); Other Names: serial number 022-00
Active Comparator: Buccal and 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.	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); Other Names: serial number 022-00; Drug: Misoprostol (given vaginally); 400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms); Other Names: serial number 022-00

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
The secondary objectives are to compare the side effects and acceptability by the subjects.	March 2007 to March 2008

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Collaborators: NEGATIVE
• Investigators: Principal Investigator: BASHAR Y F HANOOSHI, CABOG, IRAQI MEDICAL SPECIALIZATION/IRAQ

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: May 1, 2009
• First Submitted That Met QC Criteria: May 1, 2009
• First Posted (Estimate): May 4, 2009

Study Record Updates

• Last Update Posted (Estimate): May 4, 2009
• Last Update Submitted That Met QC Criteria: May 1, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: first trimester; vaginal; cervical ripening; Misoprostol; buccal; missed abortion; First trimester missed abortion
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Missed; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: IMS - 1769