Pregnancy Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Terminated |
NCT02546193 -
Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction
|
N/A |