Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426491
Status:
COMPLETED
Last Update Posted:
2008-02-08
First Post:
2007-01-22
Brief Title:
Misoprostol for Non-Viable Pregnancies
Sponsor:
Madigan Army Medical Center
Organization:
Madigan Army Medical Center
Study Overview
Official Title:
Misoprostol for the Medical Management of Non-Viable First Trimester Pregnancies
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Patients presenting to the OBGYN 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 OBGYN 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 DC 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
Patients with evidence of a gestational sac will be given a second dose of Misoprostol or a DC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None