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

Aswan University Hospital

Status

Unknown

Conditions

IUCD Complication

Treatments

Drug: Misoprostol

Drug: Isonicotinic Acid Hydrazide

Study type

Interventional

Funder types

Other

Identifiers

NCT04500002

aswu/354/3/19

Details and patient eligibility

About

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.

Full 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

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

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

240 participants in 2 patient groups

INH

Experimental group

Description:

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.

Treatment:

Drug: Misoprostol

Drug: Isonicotinic Acid Hydrazide

Misoprostol

Active Comparator group

Description:

Misoprostol Alone 800 mcg every three hours up to maximum three doses

Treatment:

Drug: Misoprostol