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

NCT04500002 | Unknown DMC

• 1 other identifier: aswu/354/3/19
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IUCD Complication

Outcome Measures

Primary Outcomes (2)

• number of patients with complete abortion

  number of patients with complete abortion

  12 hours

• time from induction to abortion

  time from induction to abortion

  12 hours

Secondary Outcomes (1)

• number of the women will undergo dilatation and curettage after failed medical induction of abortion

  12 hours

Study Arms (2)

INH

EXPERIMENTAL

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.

Drug: Isonicotinic Acid Hydrazide; Drug: Misoprostol

Misoprostol

ACTIVE COMPARATOR

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

Drug: Misoprostol

Interventions

Isonicotinic Acid Hydrazide DRUG

total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion

INH

Misoprostol DRUG

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

INH; Misoprostol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women with gestational age of less than 10 week
• 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

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 letrozole.
• Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Interventions

Isoniazid; Misoprostol

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; 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

Central Study Contacts

hany f Sallam, md

CONTACT

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

nahla waer Shady

CONTACT

+201022336052; hanygyne@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind randomized parallel assign controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: double blind randomized parallel assign controlled trial

Study Record Dates

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

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)