Abortion, MissedPhase 4NCT04499976
Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage
A Phase 4 study testing Isonicotinic Acid and Misoprostol in people with Abortion, Missed, run by Aswan University Hospital at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abortion, Missed
- What is being tested?
- Isonicotinic Acid and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Isonicotinic Acid Hydrazide (INH) With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial
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.
- Conditions
- Abortion, Missed
- Being tested
- Isonicotinic Acid, Placebo, Misoprostol
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isonicotinic AcidDrug
Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days
PlaceboDrug
Drug: placebo then misoprostol Drug: Placebo placebo for 3 days
MisoprostolDrug
Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Placebo; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction to abortion time
induction to abortion time
Measured: 9 hours
number of patient with complete abortion
number of patient with complete abortion
Measured: 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
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, MissedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- nahla w Shady, Study chair, Aswan universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499976
- Sponsor's protocol ID
- aswu/353/3/19
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Isonicotinic Acid Hydrazide (INH) With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04499976
- Acronym / sponsor ID
- aswu/353/3/19
- Conditions
- Abortion, Missed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| INH | Experimental | Drug: Isonicotinic Acid, Drug: Misoprostol3 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. |
| Placebo Comparator | Placebo comparator | Drug: Placebo, Drug: Misoprostolthree 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Molar pregnancy
- Fibroid uterus.
- Uterine anomalies.
- Coagulopathy
- Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isonicotinic AcidDrug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days | Drug | INH |
| PlaceboDrug: placebo then misoprostol Drug: Placebo placebo for 3 days | Drug | Placebo Comparator |
| MisoprostolDrug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion | Drug | INH, Placebo Comparator |
Primary outcome
induction to abortion time
Time frame: 9 hours
induction to abortion time
number of patient with complete abortion
Time frame: 9 hours
number of patient with complete abortion
1 secondary outcome
number of patient need for surgical evacuation of the products of conception
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nahla w Shady study chair
Aswan universirty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isonicotinic Acid and Misoprostol in people with Abortion, Missed, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hany f Sallam, md (+20102435461 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
induction to abortion time (time frame: 9 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.