ClinicalTrials.gg
Status unknownNCT04499976Updated Aug 5, 2020

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

A Phase 4 interventional study of Isonicotinic Acid and Placebo in Abortion, Missed, sponsored by Aswan University Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Aswan University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Abortion, Missed with a site in Egypt — none open to participants now, none under way, none of them phase 3. Abortion, Missed · Egypt.

Planned enrollment
3rd of 11
240 · median 140
Started
2020
the only one that year
Phase 4
2 of 12
none open now
Registered
8th of 12
by date
Lead sponsor
1 of 12
Aswan University Hospital

Among the 12 studies in Abortion, Missed with a site in Egypt, this one is the 3rd largest by planned enrollment of the 11 interventional ones, is the only one that started in 2020, is one of 2 in phase 4, and was the 8th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phase3 · 0 open
Phase 23 · 0 open
Phase 32 · 0 open
Phase 4this study2 · 0 open
Observational1 · 0 open
Phase 11 · 0 open

By the year they started

First in 2015; this study’s year is marked. 1 started in 2020.

Size and results

Median enrollment 140 across the 11 interventional studies, 320 across the 1 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.

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Download CSVWith an account: the 12 studies in Abortion, Missed with a site in Egypt as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Abortion, Missed

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04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gestational age less than 70 days gestation (\<10 wks).
  • >10 g/dL.
  • between 18.5 kg/m2 and 30 kg/m2.
  • Missed abortion
  • previous one or more cesarean deliveries

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • 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: 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

  • DrugIsonicotinic Acid

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

  • DrugPlacebo

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

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

06

What researchers measure

Primary outcomes

  1. induction to abortion time

    induction to abortion time

    Time frame: 9 hours

  2. number of patient with complete abortion

    number of patient with complete abortion

    Time frame: 9 hours

Secondary outcomes

  1. number of patient need for surgical evacuation of the products of conception

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

    Time frame: 12 hours

07

Study locations

1 site
  • Aswan University Hospital
    Aswan, 81528, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2020; primary completion for Apr 2021, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2020
First posted
Aug 5, 2020
StartEst.
Sep 1, 2020
Primary completionEst.
Apr 30, 2021
CompletionEst.
Jun 30, 2021
Last update
Aug 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04499976
Lead sponsor
Aswan University Hospital
Responsible party
hany farouk (A Professor, Aswan University Hospital) — Principal investigator
First posted
Aug 5, 2020
Start date
Sep 1, 2020 (estimated)
Primary completion
Apr 30, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Aug 5, 2020

Study contacts

hany f Sallam, md
Contact
hany.farouk@aswu.edu.eg
+20102435461 ext. 002
nahla w Shady, md
Contact
hanygyne@yahoo.com
+201022336052 ext. 002
nahla w Shady
study chair · Aswan universirty

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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