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

Abortion, Missed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04499976
• Other study ID #: aswu/353/3/19
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: June 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

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 30, 2021
• Est. primary completion date: April 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

• 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.

Related Conditions & MeSH terms

• Abortion, Missed
• Abortion, Spontaneous

Intervention

Drug:
• Isonicotinic Acid
Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days
• Placebo
Drug: placebo then misoprostol Drug: Placebo placebo for 3 days
• Misoprostol
Drug: 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	induction to abortion time	induction to abortion time	9 hours
Primary	number of patient with complete abortion	number of patient with complete abortion	9 hours
Secondary	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