Misoprostol for Non-Viable Pregnancies

Misoprostol for the Medical Management of Non-Viable First Trimester Pregnancies

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Abortifacient Agents, Nonsteroidal; Abortion, Incomplete; Misoprostol
• Intervention / Treatment: Drug: Misoprostol

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Cytotec
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 Names: Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to resolution	24hrs, and then weekly, after insertion
percentage requiring dilation and curettage	24hrs, and then weekly, after insertion
failure to expel products of conception	24hrs, and then weekly, after insertion
change in hematocrit	24hrs, and then weekly, after insertion
side effects	24hrs, and then weekly, after insertion
BHCG level	24hrs, and then weekly, after insertion

Collaborators and Investigators

• Sponsor: Madigan Army Medical Center
• Investigators: Principal Investigator: Jasmine Han, MD, Madigan Army Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 1999
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: January 22, 2007
• First Submitted That Met QC Criteria: January 22, 2007
• First Posted (Estimate): January 24, 2007

Study Record Updates

• Last Update Posted (Estimate): February 8, 2008
• Last Update Submitted That Met QC Criteria: February 1, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Incomplete; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 99077