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Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

Primary Purpose

Missed Abortion

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Misoprostol Pill
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missed Abortion

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women with an ultrasound diagnosis of missed abortion < 13 weeks gestation without any clinical criteria of Inevitable abortion.

Exclusion Criteria:

  • Patients refused the medical treatment.
  • Patients have contraindications of the drug (Misoprostol).
  • Missed abortion associated with any signs of sepsis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Sublingual Misoprostol for termination of first trimester missed abortion

    Vaginal Misoprostol for termination of first trimester missed abortion

    Arm Description

    Patients diagnosed as first trimester missed abortion will receive sublingual Misoprostol 800 micrograms every 4 hours up to five doses

    Patients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses

    Outcomes

    Primary Outcome Measures

    The occurance of complete abortion within 24 hours with Misoprostol drug
    Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion
    Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug
    Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion

    Secondary Outcome Measures

    Full Information

    First Posted
    August 2, 2021
    Last Updated
    August 6, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05001061
    Brief Title
    Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion
    Official Title
    Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 3, 2021 (Anticipated)
    Primary Completion Date
    October 15, 2021 (Anticipated)
    Study Completion Date
    October 16, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion
    Detailed Description
    study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Missed Abortion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    288 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sublingual Misoprostol for termination of first trimester missed abortion
    Arm Type
    Active Comparator
    Arm Description
    Patients diagnosed as first trimester missed abortion will receive sublingual Misoprostol 800 micrograms every 4 hours up to five doses
    Arm Title
    Vaginal Misoprostol for termination of first trimester missed abortion
    Arm Type
    Active Comparator
    Arm Description
    Patients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses
    Intervention Type
    Drug
    Intervention Name(s)
    Misoprostol Pill
    Intervention Description
    sublingual versus vaginal Misoprostol in termination of first trimester missed abortion
    Primary Outcome Measure Information:
    Title
    The occurance of complete abortion within 24 hours with Misoprostol drug
    Description
    Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion
    Time Frame
    Within 24 hours
    Title
    Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug
    Description
    Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion
    Time Frame
    within 24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women with an ultrasound diagnosis of missed abortion < 13 weeks gestation without any clinical criteria of Inevitable abortion. Exclusion Criteria: Patients refused the medical treatment. Patients have contraindications of the drug (Misoprostol). Missed abortion associated with any signs of sepsis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Emam
    Phone
    01003304781
    Email
    emam3882@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32700359
    Citation
    Allameh Z, Goharian M, Eslamian M. Effect of misoprostol with and without letrozole on the induction of abortion for women with first-trimester missed abortion. Int J Gynaecol Obstet. 2020 Nov;151(2):214-218. doi: 10.1002/ijgo.13326. Epub 2020 Sep 1.
    Results Reference
    background
    PubMed Identifier
    17963768
    Citation
    Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: pharmacokinetic profiles, effects on the uterus and side-effects. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S160-7. doi: 10.1016/j.ijgo.2007.09.004. Epub 2007 Oct 26.
    Results Reference
    background

    Learn more about this trial

    Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

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