Missed AbortionPhase 4NCT04215835
Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage
A Phase 4 study testing letrozole then misoprostol in people with Missed Abortion, run by Cairo University.
Trial summary
This study compares the success rate of letrozole 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 years and older, women only
- Conditions the study is for
- Missed Abortion
- What is being tested?
- letrozole then misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2020to 10 Apr 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestational age less than 64 days gestation (<9 wks).
- Hemoglobin >10 g/dL.
- BMI between 18.5 kg/m2 and 25 kg/m2.
- Missed abortion.
- previous one or more cesarean delivaries
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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Letrozole Pretreatment 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 letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.
- Conditions
- Missed Abortion
- Being tested
- letrozole then misoprostol, placebo then 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.
letrozole then misoprostolDrug
Drug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days
Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
placebo then misoprostolDrug
Drug: Placebo placebo for 3 days
Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 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 two doses. Receives: Drug: letrozole then misoprostol |
| control group | 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 then 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: 6 hours
Incidence of complete miscarriage
Incidence of complete miscarriage
Measured: 6 hours
Secondary outcomes (1)
Need for surgical evacuation of the products of conception
Need for surgical evacuation of the products of conception
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start5 Jan 2020 (estimated)
- Primary completion5 Apr 2020 (estimated)
- Study completion10 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed AbortionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215835
- Sponsor's protocol ID
- letrozole pretreatment
- Status last verified
- Dec 2019
- First submitted
- 30 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Pretreatment 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
- NCT04215835
- Acronym / sponsor ID
- letrozole pretreatment
- Conditions
- Missed Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jan 2020 (estimated)
- Primary completion
- 5 Apr 2020 (estimated)
- Study completion
- 10 Apr 2020 (estimated)
- First posted
- 2 Jan 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 letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: letrozole then misoprostol3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 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 two doses. |
| control group | Placebo comparator | Drug: placebo then 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 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gestational age less than 64 days gestation (<9 wks).
- Hemoglobin >10 g/dL.
- BMI between 18.5 kg/m2 and 25 kg/m2.
- Missed abortion.
- previous one or more cesarean delivaries
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 |
|---|---|---|
| letrozole then misoprostolDrug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion | Drug | study group |
| placebo then misoprostolDrug: Placebo placebo for 3 days Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion | Drug | control group |
Primary outcome
induction to abortion time
Time frame: 6 hours
induction to abortion time
Incidence of complete miscarriage
Time frame: 6 hours
Incidence of complete miscarriage
1 secondary outcome
Need for surgical evacuation of the products of conception
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
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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.
AHMED SAMY principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing letrozole then misoprostol in people with Missed Abortion, run by Cairo University.
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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 AHMED SAMY (+201100681167, ahmedsamy8233@gmail.com), 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: 6 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 2 Jan 2020.