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Misoprostol for Management of Women With an Incomplete Miscarriage

Sponsor
Aswan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05088720
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
16.9
Anticipated Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks gestation, that is, before fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated with abdominal pain and cramping. The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus.

Condition or Disease Intervention/Treatment Phase
  • Drug: misoprostol 800 µg
  • Drug: misoprostol 400 µg
 N/A

Detailed Description

the aim of the study is to evaluate 2 doses with misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a double-blind placebo-controlled randomized triala double-blind placebo-controlled randomized trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
a double-blind placebo-controlled randomized trial
Primary Purpose:
Treatment
Official Title:
Comparative Study Between Two Doses of Misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment: A Randomized Clinical Trial
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: misoprostol 800 µg

received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Drug: misoprostol 800 µg
received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually
Active Comparator: misoprostol 400 µg

received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Drug: misoprostol 400 µg
received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually
Other Names:
  • Active Comparator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The number of patients with complete miscarriage at 1 week [7 days]

      The number of patients with complete miscarriage at 1 week

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation.

    • No known allergy to misoprostol.

    • Women who will be hemodynamically stable.

    • Good access to emergency facilities

    Exclusion Criteria:

    • Women with signs of severe infection ( fever > 38°)

    • Women with severe vaginal bleeding

    • Women are known to have allergies to prostaglandins

    • Severe abdominal pain requiring immediate intervention

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aswan University Hospital Aswan Egypt 81528

    Sponsors and Collaborators

    • Aswan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    hany farouk, A Professor, Aswan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05088720
    Other Study ID Numbers:
    • aswu/354/7/19
    First Posted:
    Oct 22, 2021
    Last Update Posted:
    Oct 22, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Abortion, Spontaneous
    Misoprostol

    Study Results

    No Results Posted as of Oct 22, 2021