Comparing Buccal and Vaginal Misoprostol in Management of Early Pregnancy Loss
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|ClinicalTrials.gov Identifier: NCT02141555|
Recruitment Status : Completed
First Posted : May 19, 2014
Results First Posted : August 15, 2019
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spontaneous Abortion in First Trimester||Drug: Vaginal Misoprostol Drug: Buccal Misoprostol||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Buccal and Vaginal Misoprostol in Management of Early Pregnancy Loss: a Pilot Randomized Controlled Trial|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||June 2016|
Active Comparator: Vaginal misoprostol
Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers.
Drug: Vaginal Misoprostol
Misoprostol inserted into vagina
Other Name: Vaginal Cytotec
Experimental: Buccal Misoprostol
Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes.
Drug: Buccal Misoprostol
Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.
Other Name: Buccal Cytotec
- Patient Enrollment [ Time Frame: One year ]The percentage of women who are offered enrollment and accept.
- Number of Participants With Complete Abortion [ Time Frame: one week ]Number of participants with complete abortion without surgical intervention defined as no evidence of a gestational sac on transvaginal ultrasound at the follow up visit.
- Number of Participants Who Answered 1 or 2 on a Scale of Satisfaction With the Procedure [ Time Frame: one week ]
Written surveys patients will fill out at follow up visit assessing patient's satisfaction with the procedure.
"How satisfied were you with your procedure?"
The satisfaction scale used was:
1 =Very Satisfied, comfortable, likely to recommend 3= Neutral 5= Very unsatisfied/uncomfortable, unlike to recommend
- Number of Participants Reporting 2 or 3 on a Scale of Medication Side Effects [ Time Frame: one week ]
Assessment of medication side effects including: nausea, vomiting, headache, fever (over 100.4 F), dizziness, diarrhea, bad taste, dry mouth "Did you experience any of these side effects? If so, how long did they last?"
Patients asked on a scale of 0 to 3, where:
Side Effect scale:
0 = never
1= less than one day 2 = 1 to 2 days 3 = more than 2 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141555
|United States, California|
|Universty of California San Diego Perlman Clinic|
|La Jolla, California, United States, 92037|
|University of California San Diego Medical Offices South Clinic|
|San Diego, California, United States, 92103|
|Study Director:||Janie Pak, MD, MPH||University of California, San Diego|
|Principal Investigator:||Sheila Mody, MD, MPH||University of California, San Diego|