Missed AbortionPhase 4NCT04590482
Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion
A Phase 4 study testing letrozole in people with Missed Abortion, run by Shereen Rady Abou El-fetouh.
Trial summary
this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Missed Abortion
- What is being tested?
- letrozole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2020to 8 May 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maternal age more than 18 years old.
- Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
- Hemoglobin >10 g/dl
- Missed abortion
Who cannot join
- Mullerian Uterine anomalies as septate, bicornuate uterus.
- Fibroid uterus.
- Coagulopathy.
- Medical disorder that contraindicate induction of abortion.
- Allergy to misoprostol or letrozole.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion
this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.
Read the detailed description
Intervention type: drug
Intervention name: letrozole then misoprostol
Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion
Arm group label:study group
Intervention type :drug
Intervention name:placebo then misoprostol
Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion
Arm group label: control group
- Conditions
- Missed Abortion
- Being tested
- letrozole, placebo
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
letrozoleDrug
Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion
placeboDrug
placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion
| Study group | Role | What they receive |
|---|---|---|
| letrozole then misoprostol | Experimental | description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed Receives: Drug: letrozole |
| placebo then misoprostol | Placebo comparator | Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete abortion
incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol
Measured: 6 hours
Secondary outcomes (1)
surgical evacuation
surgical evacuation for the remnants of conception among 110 patients in which 55 took letrozole before misoprostol and other 55 patients who took placebo before misoprostol
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 posted19 Oct 2020
- Study start15 Nov 2020 (estimated)
- Primary completion16 Mar 2021 (estimated)
- Study completion8 May 2021 (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.
- 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shereen Rady Abou El-fetouh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shereen Rady Abou El-fetouh, Ain Shams University
- Investigators
- shereen khedr, Principal investigator, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590482
- Sponsor's protocol ID
- Letrozole /pretreatment
- Status last verified
- Oct 2020
- First submitted
- 23 Aug 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion
- ClinicalTrials.gov ID
- NCT04590482
- Acronym / sponsor ID
- Letrozole /pretreatment
- Conditions
- Missed Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shereen Rady Abou El-fetouhUniversity, hospital or other
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 16 Mar 2021 (estimated)
- Study completion
- 8 May 2021 (estimated)
- First posted
- 19 Oct 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 will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.
Detailed description
Intervention type: drug
Intervention name: letrozole then misoprostol
Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion
Arm group label:study group
Intervention type :drug
Intervention name:placebo then misoprostol
Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion
Arm group label: control group
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 |
|---|---|---|
| letrozole then misoprostol | Experimental | Drug: letrozoledescription:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed |
| placebo then misoprostol | Placebo comparator | Drug: placeboDescription:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Maternal age more than 18 years old.
- Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
- Hemoglobin >10 g/dl
- Missed abortion
Key exclusion criteria (6 listed)
- Mullerian Uterine anomalies as septate, bicornuate uterus.
- Fibroid uterus.
- Coagulopathy.
- Medical disorder that contraindicate induction of abortion.
- Allergy to misoprostol or letrozole.
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 |
|---|---|---|
| letrozoleLetrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion | Drug | letrozole then misoprostol |
| placeboplacebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion | Drug | placebo then misoprostol |
Primary outcome
Complete abortion
Time frame: 6 hours
incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol
1 secondary outcome
surgical evacuation
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 29 Oct 2020.
- Individual participant dataSharing planned: No
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The Value of Pretreatment With Letrozole on Induction Time of Medical Evacuation With Misoprostol in Cases of Missed Abortion
Letrozole
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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.
shereen khedr principal investigator
AinShams University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing letrozole in people with Missed Abortion, run by Shereen Rady Abou El-fetouh.
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 6 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 29 Oct 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 shereen khedr (01011304478, a.m.agdy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete abortion (time frame: 6 hours). 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 29 Oct 2020.