Misoprostol for Non-Viable Pregnancies - Full Text View

Sponsored by:	Madigan Army Medical Center
Information provided by:	Madigan Army Medical Center
ClinicalTrials.gov Identifier:	NCT00426491

Purpose

The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.

Condition	Intervention	Phase
Abortifacient Agents, Nonsteroidal Abortion, Incomplete Misoprostol Pregnancy	Drug: Misoprostol	Phase III

Drug Information available for: Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Misoprostol for the Medical Management of Non-Viable First Trimester Pregnancies

Further study details as provided by Madigan Army Medical Center:

Primary Outcome Measures:

time to resolution [ Time Frame: 24hrs, and then weekly, after insertion ] [ Designated as safety issue: No ]
percentage requiring dilation and curettage [ Time Frame: 24hrs, and then weekly, after insertion ] [ Designated as safety issue: No ]
failure to expel products of conception [ Time Frame: 24hrs, and then weekly, after insertion ] [ Designated as safety issue: No ]
change in hematocrit [ Time Frame: 24hrs, and then weekly, after insertion ] [ Designated as safety issue: No ]
side effects [ Time Frame: 24hrs, and then weekly, after insertion ] [ Designated as safety issue: Yes ]
BHCG level [ Time Frame: 24hrs, and then weekly, after insertion ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	March 1999
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Four 200 ug tablets of Misoprostol	Drug: Misoprostol 400 ug Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider.
B: Placebo Comparator	Drug: Misoprostol 400 ug Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider.

Detailed Description:

Patients presenting to the OB/GYN clinic with a nonviable gestation, diagnosis documented by endovaginal ultrasound will be enrolled. Ultrasonic findings will be verified by two of the resident staff from the obstetrics and gynecology department of Madigan Army Medical Center. Patients consenting will be directed to the OB/GYN clinic for evaluation, exam, and counseling and to watch the video giving explanation of purpose of the study and the planned procedure, but also expected side effects and possible complications. Patients will be randomized into two groups: study group receiving Misoprostol per vagina and the control group receiving a placebo per vagina. Subjects will be issued an envelope and go to the pharmacy to pick up their study medication, blinded to them and the provider. They will also be given Motrin and Phenergan to help alleviate undesired side effects. Four 200 ug tablets of Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider. Patients will return in 24 hours for re-examination. If no evidence of an intrauterine pregnancy remains, patients will be informed that their miscarriage was complete, given precautions and asked to make an appointment for follow-up in 4 weeks in addition to weekly visits to the lab for quantitative BHCG. All patients will be followed until the quantitative BHCG has fallen zero to ensure resolution of the pregnancy event.

Patients with evidence of a gestational sac will be given a second dose of Misoprostol or a D&C if they choose to withdraw from the study or a surgical intervention if it is deemed clinically indicated by the attending staff. Again, subjects will be given appropriate counseling and precautions and asked to follow up in an additional 24 hours for re-evaluation. Surveys will be given at each visit and follow up to evaluate patient satisfaction and also to query for unintended side effects and complications.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Pregnant patients with nonviable pregnancy document by ultrasound
Gestation at or less than 13 weeks by ultrasound measurements
Clinically stable as determined by provider
Afebrile
Hematocrit > 30
Over 18 years of age

Exclusion Criteria:

History of allergy to, or intolerance of, misoprostol
Refusal to abstain from intercourse for 72 hours
Significant vaginal bleeding (> 2 pad/hr)
History of inflammatory bowel disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426491

Locations

United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431

Sponsors and Collaborators

Madigan Army Medical Center

Investigators

Principal Investigator:

Jasmine Han, MD

Madigan Army Medical Center

More Information

Responsible Party:	Madigan Army Medical Center ( Jasmine Han, MD )
Study ID Numbers:	99077
Study First Received:	January 22, 2007
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00426491
Health Authority:	United States: Institutional Review Board; United States: Federal Government; United States: Food and Drug Administration

Study placed in the following topic categories:

Pregnancy Complications
Misoprostol
Abortion, Spontaneous
Abortion, Incomplete

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs
Abortifacient Agents

Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009