Misoprostol for Non-Viable Pregnancies

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426491
• Other study ID #: 99077
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2007
• Last updated: February 1, 2008
• Start date: March 1999
• Est. completion date: October 2006

Study information

• Verified date: February 2008
• Source: Madigan Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abortifacient Agents, Nonsteroidal
• Abortion, Incomplete
• Misoprostol
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Madigan Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to resolution		24hrs, and then weekly, after insertion	No
Primary	percentage requiring dilation and curettage		24hrs, and then weekly, after insertion	No
Primary	failure to expel products of conception		24hrs, and then weekly, after insertion	No
Primary	change in hematocrit		24hrs, and then weekly, after insertion	No
Primary	side effects		24hrs, and then weekly, after insertion	Yes
Primary	BHCG level		24hrs, and then weekly, after insertion	No