Missed AbortionNCT04593108
Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage
An observational study of Missed Abortion, run by Dr.Dalia Mohammed Al Sayed Zaki at 1 site in Egypt.
Trial summary
Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester. Hypothesis: Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Missed Abortion
- What is being tested?
- Letrozole misoprostol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2019to 15 Nov 2020
- Phase
- Observational
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study Settings: This clinical trial will be conducted in department of obstetrics and gynecology at Zagazig General Hospital during the period between January 2019 and June 2019. Study Population: The patients will be recruited from women attending outpatient clinic of obstetrics or the emergency room of Zagazig General Hospital.
Who may be able to join
- Woman age more than 18 years old (age of legal consent).
- BMI ranges between 25 kg/m2 and 35 kg/m2.
- Gestational age of 63 days' gestation (or less).
- Missed abortion.
- Hemoglobin leve
Who cannot join
- Woman age less than 18 years old.
- BMI less than 25 kg/m2 or more than 35 kg/m2.
- Gestational age more than 63 days' gestation.
- Molar pregnancy.
- Hemoglobin level less than 10 gm/dL.
- Fibroid uterus.
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- Uterus with congenital anomalies.
- Previous attempts for induction of abortion in the current pregnancy.
- Coagulation defect i.e. coagulopathy.
- Contraindication for induction of abortion e.g. heart failure.
- Allergy to misoprostol or letrozole.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study at Zagazig General Hospital
Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
Read the detailed description
Aim of the Work
Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
Primary outcome:
Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
Secondary outcome:
- Curettage (surgical evacuation of the products of conception)
- Incomplete abortion (retained products of conception).
- Considerable bleeding that necessitates immediate evacuation.
- Conditions
- Missed Abortion
- Being tested
- Letrozole misoprostol, Misoprostol, 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.
Letrozole misoprostolDevice
Letrozole give pretreatment of abortion by misoprostol
Misoprostol, placeboDrug
Give placebo pretreatment of abortion by misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Letrozole misoprostol | Group (A):
A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start Receives: Device: Letrozole misoprostol | |
| Misoprostol,placebo | Group (B):
A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start Receives: Drug: Misoprostol, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete abortion
Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
Measured: 1week
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 Jan 2019
- Primary completion1 Oct 2020
- Study completion15 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.Dalia Mohammed Al Sayed Zaki
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Sponsor-investigator, Dr.Dalia Mohammed Al Sayed Zaki, Benha University
- Investigators
- Zagazig General hospital, Ministry hospital, Principal investigator, Zagazig general hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593108
- Sponsor's protocol ID
- Treatment of missedmiscarriage
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf.
PubMed 21252745
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study at Zagazig General Hospital
- ClinicalTrials.gov ID
- NCT04593108
- Acronym / sponsor ID
- Treatment of missedmiscarriage
- Conditions
- Missed Abortion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Dr.Dalia Mohammed Al Sayed ZakiUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 15 Nov 2020 (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.
Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
Detailed description
Aim of the Work
Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
Primary outcome:
Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
Secondary outcome:
- Curettage (surgical evacuation of the products of conception)
- Incomplete abortion (retained products of conception).
- Considerable bleeding that necessitates immediate evacuation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole misoprostol | – | Device: Letrozole misoprostolGroup (A): A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start |
| Misoprostol,placebo | – | Drug: Misoprostol, placeboGroup (B): A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study Settings: This clinical trial will be conducted in department of obstetrics and gynecology at Zagazig General Hospital during the period between January 2019 and June 2019. Study Population: The patients will be recruited from women attending outpatient clinic of obstetrics or the emergency room of Zagazig General Hospital.
Key inclusion criteria (5 listed)
- Woman age more than 18 years old (age of legal consent).
- BMI ranges between 25 kg/m2 and 35 kg/m2.
- Gestational age of 63 days' gestation (or less).
- Missed abortion.
- Hemoglobin leve
Key exclusion criteria (11 listed)
- Woman age less than 18 years old.
- BMI less than 25 kg/m2 or more than 35 kg/m2.
- Gestational age more than 63 days' gestation.
- Molar pregnancy.
- Hemoglobin level less than 10 gm/dL.
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 misoprostolLetrozole give pretreatment of abortion by misoprostol | Device | Letrozole misoprostol |
| Misoprostol, placeboGive placebo pretreatment of abortion by misoprostol | Drug | Misoprostol,placebo |
Primary outcome
Complete abortion
Time frame: 1week
Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Results publication: PubMed 21252745Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf.
- Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trialLink provided by the sponsor.
- 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.
Zagazig General hospital, Ministry hospital principal investigator
Zagazig general hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Missed Abortion, run by Dr.Dalia Mohammed Al Sayed Zaki 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 5 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: status not confirmed, as of the sponsor's last update on 20 Oct 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?
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?
Complete abortion (time frame: 1week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593108, which also lists 1 linked publication.
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 20 Oct 2020.