MiscarriagePhase 2NCT03628625
Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage
A Phase 2 study testing Letrozole 2.5mg and Misoprostol in people with Miscarriage and Missed Abortion, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Miscarriage, Missed Abortion
- What is being tested?
- Letrozole 2.5mg and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2018to 10 Dec 2018
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- 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.
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
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University, Maternity Hospital
Cairo
Dina Mansour
About this study
Official title: Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial
This study compares the success rate of letrozole 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 49 days 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
letrozole administration with misoprostol raises the rate of complete abortion
Hypothesis:
In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.
- Conditions
- Miscarriage, Missed Abortion
- Being tested
- Letrozole 2.5mg, Placebo, Misoprostol
- Medical subject headings
- Abortion, Spontaneous, Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole 2.5mgDrug
total dose 7.5 mg per day for 3 days
PlaceboDrug
Folic acid for 3 days
MisoprostolDrug
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 2.5mg; Drug: 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; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete miscarriage
Measured: 6 hours
Secondary outcomes (2)
Need for surgical evacuation of the products of conception
Measured: 6 hours
Incidence of Septic Abortion
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start10 Sep 2018
- Primary completion5 Dec 2018 (estimated)
- Study completion10 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr- dina yahia mansour, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628625
- Sponsor's protocol ID
- 0005
- Status last verified
- Oct 2018
- First submitted
- 10 May 2018
- Last updated
- 9 Oct 2018
- 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 9 Oct 2018. 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: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03628625
- Acronym / sponsor ID
- 0005
- Conditions
- Miscarriage, Missed Abortion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 5 Dec 2018 (estimated)
- Study completion
- 10 Dec 2018 (estimated)
- First posted
- 14 Aug 2018 (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.
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 49 days 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
letrozole administration with misoprostol raises the rate of complete abortion
Hypothesis:
In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.
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
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Letrozole 2.5mg, Drug: 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, 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 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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.
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 2.5mgtotal dose 7.5 mg per day for 3 days | Drug | Study group |
| PlaceboFolic acid for 3 days | Drug | Control group |
| MisoprostolMisoprosrol 800mcg will be given to all patients for induction of abortion | Drug | Control group, Study group |
Primary outcome
Incidence of complete miscarriage
Time frame: 6 hours
2 secondary outcomes
Need for surgical evacuation of the products of conception
Time frame: 6 hours
Incidence of Septic Abortion
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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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 Phase 2 study testing Letrozole 2.5mg and Misoprostol in people with Miscarriage and Missed Abortion, run by Ain Shams Maternity 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 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 9 Oct 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dina Mansour (+20100657, Dinayahiamansour@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete miscarriage (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 9 Oct 2018.