Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Abortion, Missed

Intervention / Treatment
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* Drug: Isonicotinic Acid
* Drug: Placebo
* 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 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.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind randomized controlled study
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 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. | Drug: Isonicotinic Acid<br>* Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days<br>Drug: Misoprostol<br>* Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion<br>|
| Placebo Comparator: Placebo Comparator<br>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 | Drug: Placebo<br>* Drug: placebo then misoprostol Drug: Placebo placebo for 3 days<br>Drug: Misoprostol<br>* Drug: Misoprostol 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 |
| --- | --- | --- |
| induction to abortion time | induction to abortion time | 9 hours | 
| number of patient with complete abortion | number of patient with complete abortion | 9 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patient need for surgical evacuation of the products of conception | number of patient need for surgical evacuation of the products of conception | 12 hours |