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

This study has been completed.
Sponsor:
Collaborator:
NEGATIVE
Information provided by:
Hawler Medical University
ClinicalTrials.gov Identifier:
NCT00892229
First received: May 1, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Missed Abortion
Drug: Misoprostol (given buccally)
Drug: Misoprostol (given vaginally)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil

Resource links provided by NLM:


Further study details as provided by Hawler Medical University:

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.) [ Time Frame: March 2007 to March 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary objectives are to compare the side effects and acceptability by the subjects. [ Time Frame: March 2007 to March 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: serial number 022-00

  Eligibility

Ages Eligible for Study:   19 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892229

Locations
Iraq
Iraqi Medical Specialization
Risafa, Baghdad, Iraq, 00964
Sponsors and Collaborators
Hawler Medical University
NEGATIVE
Investigators
Principal Investigator: BASHAR Y F HANOOSHI, CABOG IRAQI MEDICAL SPECIALIZATION/IRAQ
  More Information

No publications provided

Responsible Party: Dr. NADA S AMEEN - THE CHAIRWOMEN, IRAQI MEDICAL SPECIALIZATION
ClinicalTrials.gov Identifier: NCT00892229     History of Changes
Other Study ID Numbers: IMS - 1769
Study First Received: May 1, 2009
Last Updated: May 1, 2009
Health Authority: Iraq: Hawler College of Medicine/Iraqi Medical Specialization

Keywords provided by Hawler Medical University:
First trimester missed abortion
Misoprostol
buccal
vaginal
cervical ripening
first trimester
missed abortion

Additional relevant MeSH terms:
Abortion, Missed
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on October 19, 2014