IUCD ComplicationNCT04500002
Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion
A study testing Isonicotinic Acid Hydrazide and Misoprostol in people with IUCD Complication, run by Aswan University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- IUCD Complication
- What is being tested?
- Isonicotinic Acid Hydrazide and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Jul 2021
- Phase
- Interventional
- 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
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 letrozole.
- Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- IUCD Complication
- Being tested
- Isonicotinic Acid Hydrazide, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isonicotinic Acid HydrazideDrug
total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
MisoprostolDrug
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 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. Receives: Drug: Isonicotinic Acid Hydrazide; Drug: Misoprostol |
| Misoprostol | Active comparator | Misoprostol Alone 800 mcg every three hours up to maximum three doses Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with complete abortion
number of patients with complete abortion
Measured: 12 hours
time from induction to abortion
time from induction to abortion
Measured: 12 hours
Secondary outcomes (1)
number of the women will undergo dilatation and curettage after failed medical induction of abortion
number of the women will undergo dilatation and curettage after failed medical induction of abortion
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 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUCD ComplicationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized parallel assign controlled trial
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500002
- Sponsor's protocol ID
- aswu/354/3/19
- 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) Pretreatment With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04500002
- Acronym / sponsor ID
- aswu/354/3/19
- Conditions
- IUCD Complication
- 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 Jun 2021 (estimated)
- Study completion
- 30 Jul 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.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized parallel assign controlled trial
| Arm | Type | Receives |
|---|---|---|
| INH | Experimental | Drug: Isonicotinic Acid Hydrazide, Drug: Misoprostol3 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. |
| Misoprostol | Active comparator | Drug: MisoprostolMisoprostol Alone 800 mcg every three hours up to maximum three doses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 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
Key exclusion criteria (8 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 Acid Hydrazidetotal dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion | Drug | INH |
| MisoprostolMisoprosrol 800mcg will be given to all patients for induction of abortion | Drug | INH, Misoprostol |
Primary outcome
number of patients with complete abortion
Time frame: 12 hours
number of patients with complete abortion
time from induction to abortion
Time frame: 12 hours
time from induction to abortion
1 secondary outcome
number of the women will undergo dilatation and curettage after failed medical induction of abortion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isonicotinic Acid Hydrazide and Misoprostol in people with IUCD Complication, 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 4 inclusion and 8 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
number of patients with complete abortion (time frame: 12 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.