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

Aswan University Hospital

Status and phase: Unknown; Phase 4

Conditions: Abortion, Missed

Treatments: Drug: Isonicotinic Acid; Drug: Placebo; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04499976

aswu/353/3/19

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

INH

Experimental group

Description:

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.

Treatment:

Drug: Misoprostol

Drug: Isonicotinic Acid

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Misoprostol

Drug: Placebo