Back to resultsSublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
Primary Purpose
Miscarriage
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
misoprostol 400 mcg
misoprostol 800 mcg
Sponsored by
About this trial
This is an interventional treatment trial for Miscarriage focused on measuring miscarriage, sublingual, misoprostol
Eligibility Criteria
Inclusion Criteria:
- All women above 18 years of age
- Less than 12 weeks of gestation.
- Pregnancy is confirmed by pregnancy test or ultrasound scan.
- missed abortion
- Normal general and gynecological examination.
Exclusion Criteria:
- Hemodynamically unstable.
- Suspected sepsis with temperature 38 °C.
- Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
- respiratory illnesses, recent liver disease, or pruritus of pregnancy.
- Presence of intrauterine contraceptive device (IUCD).
- Suspect or proven ectopic pregnancy.
- Failed medical or surgical evacuation before the presentation.
- Known allergy to misoprostol.
Sites / Locations
- Aswan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
misoprostol 400 mcg
misoprostol 800 mcg
Arm Description
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Two doses of misoprostol 800 mcg each (2 tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
Outcomes
Primary Outcome Measures
Completeness of abortion
Number of Participants with expulsion of Products of conception by visual inspection
Secondary Outcome Measures
Successful medical abortion
Number of Participants with cervical os is closed with endometrial thickness of less than 15 mm
amount of calculated blood loss following treatment
amount of calculated blood loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05103098
Brief Title
Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
Official Title
Sublingual Misoprostol 400 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
hany farouk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.
Detailed Description
the study will be made on female patients with the first trimester missed abortion confirmed by ultrasound. Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol 400 mcg and the other group(B) will receive sublingual Misoprostol 800 mcg every 4 hours in both groups up to 3 doses the aim of the study is to compare the efficacy of sublingual Misoprostol in complete termination of the 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
Miscarriage
Keywords
miscarriage, sublingual, misoprostol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a double-blind randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
a double-blind randomized controlled trial
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
misoprostol 400 mcg
Arm Type
Experimental
Arm Description
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Two doses of misoprostol 800 mcg each (2 tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
Arm Title
misoprostol 800 mcg
Arm Type
Active Comparator
Arm Description
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
Intervention Type
Drug
Intervention Name(s)
misoprostol 400 mcg
Other Intervention Name(s)
experimental
Intervention Description
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Two doses of misoprostol 400 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
Intervention Type
Drug
Intervention Name(s)
misoprostol 800 mcg
Other Intervention Name(s)
Active Comparator
Intervention Description
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
Primary Outcome Measure Information:
Title
Completeness of abortion
Description
Number of Participants with expulsion of Products of conception by visual inspection
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Successful medical abortion
Description
Number of Participants with cervical os is closed with endometrial thickness of less than 15 mm
Time Frame
7 days
Title
amount of calculated blood loss following treatment
Description
amount of calculated blood loss
Time Frame
7 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women with missed abortion in the first trimester
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All women above 18 years of age
Less than 12 weeks of gestation.
Pregnancy is confirmed by pregnancy test or ultrasound scan.
missed abortion
Normal general and gynecological examination.
Exclusion Criteria:
Hemodynamically unstable.
Suspected sepsis with temperature 38 °C.
Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
respiratory illnesses, recent liver disease, or pruritus of pregnancy.
Presence of intrauterine contraceptive device (IUCD).
Suspect or proven ectopic pregnancy.
Failed medical or surgical evacuation before the presentation.
Known allergy to misoprostol.
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
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