Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage
NCT ID: NCT04499976
Last Updated: 2020-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2020-09-01
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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INH
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.
Isonicotinic Acid
Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days
Misoprostol
Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Placebo Comparator
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
Placebo
Drug: placebo then misoprostol Drug: Placebo placebo for 3 days
Misoprostol
Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Interventions
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Isonicotinic Acid
Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days
Placebo
Drug: placebo then misoprostol Drug: Placebo placebo for 3 days
Misoprostol
Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Eligibility Criteria
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Inclusion Criteria
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 30 kg/m2.
* Missed abortion
* previous one or more cesarean deliveries
Exclusion Criteria
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Aswan University Hospital
OTHER
Responsible Party
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hany farouk
A Professor
Principal Investigators
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nahla w Shady
Role: STUDY_CHAIR
Aswan universirty
Locations
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Aswan University Hospital
Aswān, , Egypt
Countries
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Central Contacts
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Other Identifiers
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aswu/353/3/19
Identifier Type: -
Identifier Source: org_study_id
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