Back to resultsIsonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage
Primary Purpose
Abortion, Missed
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Isonicotinic Acid
Placebo
Misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Abortion, Missed
Eligibility Criteria
Inclusion Criteria:
- Gestational age less than 70 days gestation (<10 wks).
- Hemoglobin >10 g/dL.
- BMI between 18.5 kg/m2 and 30 kg/m2.
- Missed abortion
- previous one or more cesarean deliveries
Exclusion Criteria:
- Molar pregnancy
- Fibroid uterus.
- Uterine anomalies.
- Coagulopathy
- Medical disorder that contraindicate induction of abortion (e.g. heart failure).
- Previous attempts for induction of abortion in the current pregnancy.
- Allergy to misoprostol or INH.
Sites / Locations
- Aswan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
INH
Placebo Comparator
Arm Description
3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily dose, 900 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
Outcomes
Primary Outcome Measures
induction to abortion time
induction to abortion time
number of patient with complete abortion
number of patient with complete abortion
Secondary Outcome Measures
number of patient need for surgical evacuation of the products of conception
number of patient need for surgical evacuation of the products of conception
Full Information
NCT ID
NCT04499976
First Posted
August 2, 2020
Last Updated
August 4, 2020
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04499976
Brief Title
Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage
Official Title
Adjuvant Isonicotinic Acid Hydrazide (INH) With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (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
This study compares the success rate of Adjuvant isonicotinic acid hydrazide and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.
Detailed Description
In the past, the role of laminaria and prostaglandins in cervical dilatation and reducing intraoperative complications of cervical dilatation have been proven . Misoprostol is a synthetic analogue of prostaglandin E1 used to treat and prevent gastric ulcers, which is now widely used in obstetrics and gynecology. Its applications in obstetrics and gynecology include medical abortion in the first and second trimesters of pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Missed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
double blind randomized controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind randomized controlled study
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
INH
Arm Type
Experimental
Arm Description
3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily dose, 900 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
Intervention Type
Drug
Intervention Name(s)
Isonicotinic Acid
Intervention Description
Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Drug: placebo then misoprostol Drug: Placebo placebo for 3 days
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Primary Outcome Measure Information:
Title
induction to abortion time
Description
induction to abortion time
Time Frame
9 hours
Title
number of patient with complete abortion
Description
number of patient with complete abortion
Time Frame
9 hours
Secondary Outcome Measure Information:
Title
number of patient need for surgical evacuation of the products of conception
Description
number of patient need for surgical evacuation of the products of conception
Time Frame
12 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with one or more previous cesarean deliveries with missed miscarriage
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age less than 70 days gestation (<10 wks).
Hemoglobin >10 g/dL.
BMI between 18.5 kg/m2 and 30 kg/m2.
Missed abortion
previous one or more cesarean deliveries
Exclusion Criteria:
Molar pregnancy
Fibroid uterus.
Uterine anomalies.
Coagulopathy
Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Previous attempts for induction of abortion in the current pregnancy.
Allergy to misoprostol or INH.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f Sallam, md
Phone
+20102435461
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
nahla w Shady, md
Phone
+201022336052
Ext
002
Email
hanygyne@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nahla w Shady
Organizational Affiliation
Aswan universirty
Official's Role
Study Chair
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
Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage
We'll reach out to this number within 24 hrs