Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil - Full Text View

Sponsors and Collaborators:	Hawler Medical University NEGATIVE
Information provided by:	Hawler Medical University
ClinicalTrials.gov Identifier:	NCT00892229

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 II

MedlinePlus related topics: Surgery

Drug Information available for: Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil

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

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

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

Locations

Iraq, BAGHDAD
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:	IRAQI MEDICAL SPECIALIZATION ( Dr. NADA S AMEEN - THE CHAIRWOMEN )
Study ID Numbers:	IMS - 1769
Study First Received:	May 1, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00892229 History of Changes
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

Study placed in the following topic categories:

Pregnancy Complications
Abortion, Missed
Misoprostol
Abortion, Spontaneous

Additional relevant MeSH terms:

Pregnancy Complications
Abortion, Missed
Oxytocics
Misoprostol
Physiological Effects of Drugs
Gastrointestinal Agents
Reproductive Control Agents

Abortifacient Agents, Nonsteroidal
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Anti-Ulcer Agents
Abortion, Spontaneous

ClinicalTrials.gov processed this record on May 07, 2009