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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
Sponsor:
Information provided by (Responsible Party):
Sheila Mody, University of California, San Diego

Brief Summary:
First trimester miscarriages are common. When the failed pregnancy does not pass spontaneously on its own, it is called a missed abortion. There are several ways in which missed abortions are managed, one of which involves administering a medication called misoprostol which causes uterine contractions inducing expulsion of the failed pregnancy. Misoprostol can be administered in multiple ways but has been traditionally inserted vaginally when used for management of missed abortions. Some studies have shown that some women are not comfortable with vaginal insertion of misoprostol and prefer oral administration. Buccal misoprostol is a way of administering misoprostol by having the patients insert the tablets of misoprostol between their gum and cheek, letting it dissolve for 30 minutes, then swallowing the remaining remnants. Buccal misoprostol is used safely in medical abortion. In fact a study by Fjerstad et al (2009), found a decrease in infection rate for medical abortion when misoprostol administration was switched from vaginal to buccal route combined with routine administration of doxycycline. The efficacy of using buccal misoprostol to treat missed abortions has not been studied previously to the investigators' knowledge. In this pilot study, investigators aim to test the hypotheses that buccal misoprostol is equally effective as vaginal misoprostol in the medical management of early pregnancy loss. As secondary outcomes, investigators suspect that buccal misoprostol may be associated with higher rates of gastrointestinal side effect but that patient satisfaction will remain equally as high for buccal misoprostol as for vaginal misoprostol.

Condition or disease Intervention/treatment Phase
Spontaneous Abortion in First Trimester Drug: Vaginal Misoprostol Drug: Buccal Misoprostol Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage
Drug Information available for: Misoprostol

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Patient Enrollment [ Time Frame: One year ]
    The percentage of women who are offered enrollment and accept.


Secondary Outcome Measures :
  1. 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.

  2. 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


  3. 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




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ages 18-50 who are English or Spanish speaking
  • First trimester pregnancy (less than 13 weeks and 0 days)
  • Desires medical management of an early pregnancy loss with misoprostol
  • Diagnosed with an early pregnancy failure by UCSD Radiology or diagnosed early pregnancy failure defined by any of the following criteria (Bourne 2013):

    • Crown-rump length > 7mm with no cardiac activity
    • Mean gestational sac diameter of > 25 mm and no embryo
    • Absence of an embryo with heartbeat > 2 weeks after a scan showing a gestational sac without a yolk sac
    • Absence of embryo with heartbeat > 11 days after a scan showing a gestational sac with a yolk sac

Exclusion Criteria:

  • Evidence of infection, acute hemorrhage, or hemodynamic instability
  • Hemoglobin less than 9.5 including use of point of care Hgb testing
  • Known allergy to misoprostol
  • Underwent surgical or medical abortion during current pregnancy
  • Currently breastfeeding
  • Currently has intrauterine device in place
  • Suspicion of ectopic or gestational trophoblastic disease
  • History of clotting disorder or on anticoagulant therapy (excluding aspirin)
  • Unreliable for follow up

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of California, San Diego
Investigators
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Study Director: Janie Pak, MD, MPH University of California, San Diego
Principal Investigator: Sheila Mody, MD, MPH University of California, San Diego
Publications:

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Responsible Party: Sheila Mody, Assistant Adjunct Professor, Section of Family Planning, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02141555    
Other Study ID Numbers: 140250
First Posted: May 19, 2014    Key Record Dates
Results First Posted: August 15, 2019
Last Update Posted: August 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sheila Mody, University of California, San Diego:
misoprostol, early pregnancy loss, missed abortion
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics