Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

Sponsor
Aswan University Hospital
Study ID
NCT04500002
Status
Unknown

Conditions

  • IUCD Complication

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Isonicotinic Acid Hydrazide — DRUG
    total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
  • Misoprostol — DRUG
    Misoprosrol 800mcg will be given to all patients for induction of abortion

Study Details

The primary endpoint was the success rate of adjuvant isonicotinic acid hydrazide (INH) and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.

Key Dates

Start date
Sep 1, 2020
Status verified
Aug 2020
Primary completion
Jun 30, 2021
Completion
Jul 30, 2021

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: INH
    3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily doses, 5 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 three doses.
  • Active Comparator: Misoprostol
    Misoprostol Alone 800 mcg every three hours up to maximum three doses

Primary Outcome Measure

number of patients with complete abortion [ Time Frame: 12 hours ]

Central Contacts