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

IUCD Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04500002
• Other study ID #: aswu/354/3/19
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2020
• Source: Aswan University Hospital
• Contact: hany f Sallam, md
• Phone: +20102435461
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• IUCD Complication

Intervention

Drug:
• Isonicotinic Acid Hydrazide
total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
• Misoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with complete abortion	number of patients with complete abortion	12 hours
Primary	time from induction to abortion	time from induction to abortion	12 hours
Secondary	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