Misoprostol for Non-Viable Pregnancies

This study has been completed.
Sponsor:
Information provided by:
Madigan Army Medical Center
ClinicalTrials.gov Identifier:
NCT00426491
First received: January 22, 2007
Last updated: February 1, 2008
Last verified: February 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Misoprostol for the Medical Management of Non-Viable First Trimester Pregnancies

Resource links provided by NLM:


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
Active Comparator: A
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.
Other Name: Cytotec
Placebo Comparator: B 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.
Other Name: Cytotec

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
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: 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

No publications provided

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

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

ClinicalTrials.gov processed this record on October 21, 2014