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

Study Overview
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Brief Summary
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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
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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

Official Title
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Adjuvant Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage: A Randomized Controlled Trial

Conditions
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IUCD Complication

Intervention / Treatment
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* Drug: Isonicotinic Acid Hydrazide
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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 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 letrozole. Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind randomized parallel assign controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INH<br>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. | Drug: Isonicotinic Acid Hydrazide<br>* total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion<br>Drug: Misoprostol<br>* Misoprosrol 800mcg will be given to all patients for induction of abortion<br>|
| Active Comparator: Misoprostol<br>Misoprostol Alone 800 mcg every three hours up to maximum three doses | Drug: Misoprostol<br>* Misoprosrol 800mcg will be given to all patients for induction of abortion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with complete abortion | number of patients with complete abortion | 12 hours | 
| time from induction to abortion | time from induction to abortion | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of the women will undergo dilatation and curettage after failed medical induction of abortion | number of the women will undergo dilatation and curettage after failed medical induction of abortion | 12 hours |