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

August 4, 2020 updated by: hany farouk, Aswan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INH
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
total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
Drug: Misoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion
Active Comparator: Misoprostol
Misoprostol Alone 800 mcg every three hours up to maximum three doses
Drug: Misoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with complete abortion
Time Frame: 12 hours
number of patients with complete abortion
12 hours
time from induction to abortion
Time Frame: 12 hours
time from induction to abortion
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of the women will undergo dilatation and curettage after failed medical induction of abortion
Time Frame: 12 hours
number of the women will undergo dilatation and curettage after failed medical induction of abortion
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

July 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

Other Study ID Numbers

  • aswu/354/3/19

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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