Back to resultsSublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage
Primary Purpose
Miscarriage
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sublingual misoprostol
vaginal misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Miscarriage focused on measuring miscarriage, sublingual, vaginal, misoprostol
Eligibility Criteria
Inclusion Criteria:
- All women above 18 years of age
- between 13-26 weeks of gestation.
- Pregnancy is confirmed by a 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
sublingual misoprostol
vaginal misoprostol
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
All patients will receive three doses of vaginal 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. Paracetamol, eight hourly, will be provided as analgesic or antipyretic
Outcomes
Primary Outcome Measures
Completeness of abortion
expulsion of Products of conception by visual inspection
Secondary Outcome Measures
Successful medical abortion
cervical os is closed with endometrial thickness of less than 15 mm
Bleeding pattern following treatment
This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding
Full Information
NCT ID
NCT05088707
First Posted
October 10, 2021
Last Updated
October 10, 2021
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05088707
Brief Title
Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage
Official Title
Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric 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
Principal Investigator
Name of the Sponsor
Aswan University Hospital
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 vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage
Detailed Description
In women with second trimester-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage
Keywords
miscarriage, sublingual, vaginal, misoprostol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
an open-label randomized controlled study
Masking
None (Open Label)
Masking Description
an open-label randomized controlled study
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sublingual misoprostol
Arm Type
Experimental
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
Arm Title
vaginal misoprostol
Arm Type
Active Comparator
Arm Description
All patients will receive three doses of vaginal 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.
Paracetamol, eight hourly, will be provided as analgesic or antipyretic
Intervention Type
Drug
Intervention Name(s)
sublingual misoprostol
Other Intervention Name(s)
experimental
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 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 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)
vaginal misoprostol
Other Intervention Name(s)
Active Comparator
Intervention Description
All patients will receive three doses of vaginal 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.
Paracetamol, eight hourly, will be provided as analgesic or antipyretic
Primary Outcome Measure Information:
Title
Completeness of abortion
Description
expulsion of Products of conception by visual inspection
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Successful medical abortion
Description
cervical os is closed with endometrial thickness of less than 15 mm
Time Frame
7 days
Title
Bleeding pattern following treatment
Description
This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding
Time Frame
7 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women with second missed abortion
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
between 13-26 weeks of gestation.
Pregnancy is confirmed by a 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany F Sallam, md
Phone
+201112505221
Ext
002
Email
hanysallam876@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
nahla w Shady, md
Phone
+201022336052
Ext
002
Email
hanygyne@yahoo.com
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 Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage
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