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

NCT ID: NCT04500002

Last Updated: 2020-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-07-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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IUCD Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind randomized parallel assign controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double blind randomized parallel assign controlled trial

Study Groups

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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.

Group Type EXPERIMENTAL

Isonicotinic Acid Hydrazide

Intervention Type DRUG

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

Misoprostol

Intervention Type DRUG

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

Misoprostol

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

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Misoprostol

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

A Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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hany f Sallam, md

Role: CONTACT

+20102435461 ext. 002

nahla waer Shady

Role: CONTACT

+201022336052 ext. 002

Other Identifiers

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aswu/354/3/19

Identifier Type: -

Identifier Source: org_study_id

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