MiscarriagePhase 2/3NCT02405156
Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
A Phase 2/3 study testing Letrozole and Misoprostol in people with Miscarriage, run by Ain Shams University at 1 site in Egypt.
Trial summary
To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion. 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
- What is being tested?
- Letrozole and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Dec 2016
- Phase
- Phase 2/3
- 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
- Maternal age more than 18 years old (age of legal consent).
- Gestational age between 12 weeks and 24 weeks.
- Hemoglobin >10 g/dL.
- BMI between 25 kg/m2 and 35 kg/m2.
- Miscarriage .
- Living fetus with multiple congenital malformations incompatible with life.
- PPROMs with drained liquor and parents are consenting for termination of pregnancy.
Who cannot join
- Maternal age less than 18 years old.
- Gestational age less than 12 weeks or more than 24 weeks.
- Hemoglobin <10 g/dL.
- Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
- Polyhydraminos.
- Anencephaly.
Show all 11Show fewer
- Fibroid uterus.
- BMI less than 25kg/m2 and more than 35kg/m2.
- Coagulopathy.
- History or evidence of adrenal pathology.
- Previous attempts for induction of abortion in the current pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Double-Blind, Randomized, Placebo-Controlled Trial on the Use of Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion.
Read the detailed description
This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital.
Patients fulfilling inclusion and exclusion criteria will be divided into two groups.
Group (A):
181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Group (B):
181 women will receive three tablets of placebo (manufactured by Egyptian Group Company for drug industries) as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Data recording:
- Duration of complete abortion.
- Post abortion bleeding.
- Incomplete delivery of the placenta necessitates evacuation under anesthesia.
- Hemoglobin and hematocrit after 24 hours from abortion to estimate the decrease in hemoglobin level.
- Recording maternal morbidities.
- Patients that will receive 5 doses and did not abort till 24 hours from the first dose of misoprostol will be considered failed induction and will stop follow up without reporting outcome.
- Conditions
- Miscarriage
- Being tested
- Letrozole, Placebo, Misoprostol
- Keywords
- Letrozole, misoprostol, second trimester miscarriage
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called femara
PlaceboDrug
MisoprostolDrug
| Study group | Role | What they receive |
|---|---|---|
| letrozole + misoprostol | Experimental | Women will receive three tablets of letrozole vaginal as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for three days and will be followed by 200 mcg vaginal misoprostol or 100mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses. Receives: Drug: Letrozole; Drug: Misoprostol |
| placebo + misoprostol | Placebo comparator | Women will receive three tablets of placebo vaginal as a single dose, for three days and will be followed by 200 mcg vaginal misoprostol or 100 mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses. Receives: Drug: Placebo; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of induction of abortion
Measured: 24 hours
Secondary outcomes (5)
The incidence of need for surgical evacuation of placenta.
Measured: 24 hours
Hemoglobin change
Measured: 24 hours
Maternal morbidity
Measured: 24 hours
Success of induction of abortion
number of participants with Success of induction of abortion
Measured: 24 hours
Hematocrit change
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
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.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
- Investigators
- Mostafa Gomaa, MD, Principal investigator, Ain Shams UniversityIhab Serag-ElDin, MD, Study director, Ain Shams UniversityGasser El-Bishry, FRCOG, Study director, Ain Shams UniversityAhmed Swidan, M.B.B.ch, Principal investigator, Ain Shams UniversityMohamed S. Sweed, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405156
- Sponsor's protocol ID
- 305172
- Status last verified
- Jan 2017
- First submitted
- 16 Mar 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double-Blind, Randomized, Placebo-Controlled Trial on the Use of Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
- ClinicalTrials.gov ID
- NCT02405156
- Acronym / sponsor ID
- 305172
- Conditions
- Miscarriage
- Keywords
- Letrozole, misoprostol, second trimester miscarriage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Apr 2015 (estimated)
- 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.
To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion.
Detailed description
This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital.
Patients fulfilling inclusion and exclusion criteria will be divided into two groups.
Group (A):
181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Group (B):
181 women will receive three tablets of placebo (manufactured by Egyptian Group Company for drug industries) as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Data recording:
- Duration of complete abortion.
- Post abortion bleeding.
- Incomplete delivery of the placenta necessitates evacuation under anesthesia.
- Hemoglobin and hematocrit after 24 hours from abortion to estimate the decrease in hemoglobin level.
- Recording maternal morbidities.
- Patients that will receive 5 doses and did not abort till 24 hours from the first dose of misoprostol will be considered failed induction and will stop follow up without reporting outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| letrozole + misoprostol | Experimental | Drug: Letrozole, Drug: MisoprostolWomen will receive three tablets of letrozole vaginal as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for three days and will be followed by 200 mcg vaginal misoprostol or 100mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses. |
| placebo + misoprostol | Placebo comparator | Drug: Placebo, Drug: MisoprostolWomen will receive three tablets of placebo vaginal as a single dose, for three days and will be followed by 200 mcg vaginal misoprostol or 100 mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Maternal age more than 18 years old (age of legal consent).
- Gestational age between 12 weeks and 24 weeks.
- Hemoglobin >10 g/dL.
- BMI between 25 kg/m2 and 35 kg/m2.
- Miscarriage .
Key exclusion criteria (11 listed)
- Maternal age less than 18 years old.
- Gestational age less than 12 weeks or more than 24 weeks.
- Hemoglobin <10 g/dL.
- Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
- Polyhydraminos.
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 |
|---|---|---|
| LetrozoleAlso: femara | Drug | letrozole + misoprostol |
| Placebo | Drug | placebo + misoprostol |
| Misoprostol | Drug | letrozole + misoprostol, placebo + misoprostol |
Primary outcome
Duration of induction of abortion
Time frame: 24 hours
5 secondary outcomes
The incidence of need for surgical evacuation of placenta.
Time frame: 24 hours
Hemoglobin change
Time frame: 24 hours
Maternal morbidity
Time frame: 24 hours
Success of induction of abortion
Time frame: 24 hours
Hematocrit change
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
Related trials for Miscarriage
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Recruiting
The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
Early Pregnancy Bleeding
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Not yet recruitingPhase 3
Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
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.
Mostafa Gomaa, MD principal investigator
Ain Shams University
Ihab Serag-ElDin, MD study director
Ain Shams University
Gasser El-Bishry, FRCOG study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Letrozole and Misoprostol in people with Miscarriage, run by Ain Shams University 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 26 Jan 2017. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of induction of abortion (time frame: 24 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 26 Jan 2017.