Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion
- Conditions
- IUCD Complication
- Interventions
- Registration Number
- NCT04500002
- Lead Sponsor
- Aswan University Hospital
- Brief Summary
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.
- Detailed Description
According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 10 weeks based on the last menstrual period
Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week
Adjuvant isonicotinic acid hydrazide (INH) administration with misoprostol raises the rate of complete abortion
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 240
- 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
- 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 letrozole.
- Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INH Isonicotinic Acid Hydrazide 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. Misoprostol Misoprostol Misoprostol Alone 800 mcg every three hours up to maximum three doses INH Misoprostol 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.
- Primary Outcome Measures
Name Time Method number of patients with complete abortion 12 hours number of patients with complete abortion
time from induction to abortion 12 hours time from induction to abortion
- Secondary Outcome Measures
Name Time Method number of the women will undergo dilatation and curettage after failed medical induction of abortion 12 hours number of the women will undergo dilatation and curettage after failed medical induction of abortion
Trial Locations
- Locations (1)
Aswan University Hospital
🇪🇬Aswan, Egypt