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

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

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.

Study Overview

• Status: Unknown
• Conditions: Abortion, Missed
• Intervention / Treatment: Drug: Isonicotinic Acid; Drug: Misoprostol; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INH; 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; Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days; Drug: Misoprostol; Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Placebo Comparator: Placebo Comparator; 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: Misoprostol; Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion; Drug: Placebo; Drug: placebo then misoprostol Drug: Placebo placebo for 3 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aswan University Hospital
• Investigators: Study Chair: nahla w Shady, Aswan universirty

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Missed; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: aswu/353/3/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No