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

NCT04499976 | Unknown Phase 4 DMC

• 1 other identifier: aswu/353/3/19
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abortion, Missed

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• number of patient need for surgical evacuation of the products of conception

  12 hours

Study Arms (2)

INH

EXPERIMENTAL

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: Misoprostol

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: Placebo; Drug: Misoprostol

Interventions

Isonicotinic Acid DRUG

Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days

INH

Placebo DRUG

Drug: placebo then misoprostol Drug: Placebo placebo for 3 days

Placebo Comparator

Misoprostol DRUG

Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion

INH; Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women with one or more previous cesarean deliveries with missed miscarriage
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Abortion, Missed

Interventions

Isonicotinic Acids; Misoprostol

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• nahla w Shady

  Aswan universirty

  STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461; hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052; hanygyne@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind randomized controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: double blind randomized controlled study

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 5, 2020
• Study Start: September 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)