Termination of Early Pregnancy in Scarred UterusNCT05067309
Termination of Early Pregnancy in Scarred Uterus With Lletrozole and Misoprostol Compared to Misoprostol Alone
An observational study of Termination of Early Pregnancy in Scarred Uterus, run by Ahmed Elsayed Aref at 2 sites in Egypt.
Trial summary
Termination of early pregnancy in scarred uterus with letrozole and misoprostol compared to Misoprostol alone Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Termination of Early Pregnancy in Scarred Uterus
- What is being tested?
- Letrozole 2.5mg
- How many people
- 1 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2021to 1 Aug 2022
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: Termination of early pregnancy in scarred uterus with letrozole and misoprostol compared to Misoprostol alone
Who may be able to join
- Minimum age of 18 years for mother.
- Non-viable fetus (missed abortion or blighted ovum) in the 1st trimester of pregnancy evidenced by criteria for diagnosis by TVS .
- Previous C.S or Myomectomy (1 or more )
- lack of any maternal diseases such as: heart disease, asthma, history of thromboembolism, cancer, renal failure, and liver diseases.
Who cannot join
- * Medical problem in patient
- Emergency conditions which need intervention .
- History of allergy to misoprostol or letrozole drugs.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ahmed Elsayed Aref
Sohag
Ahmed Elsayed Aref, 01097993202, draelsaied2018@gmail.com
Ahmed Elsayed Aref
Sohag
About this study
Official title: Termination of Early Pregnancy in Scarred Uterus With Letrozole and Misoprostol Compared to Misoprostol Alone
Termination of early pregnancy in scarred uterus with letrozole and misoprostol compared to Misoprostol alone
- Being tested
- Letrozole 2.5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole 2.5mgDrug
Missed abortion received letrozole then misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Missed abortion received letrozole then misoprostol | Not described Receives: Drug: Letrozole 2.5mg | |
| Missed abortion received misoprostol alone | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete abortion of early pregnancy with letrozole then misoprostol
Letrozole increase cervical ripening
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Termination of Early Pregnancy in Scarred UterusStudies 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Elsayed Aref
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Elsayed Aref, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067309
- Sponsor's protocol ID
- Soh-Med-21-09-07
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Termination of Early Pregnancy in Scarred Uterus With Letrozole and Misoprostol Compared to Misoprostol Alone
- ClinicalTrials.gov ID
- NCT05067309
- Acronym / sponsor ID
- Soh-Med-21-09-07
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Ahmed Elsayed ArefUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 5 Oct 2021 (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.
Termination of early pregnancy in scarred uterus with letrozole and misoprostol compared to Misoprostol alone
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Missed abortion received letrozole then misoprostol | – | Drug: Letrozole 2.5mg |
| Missed abortion received misoprostol alone | – | – |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Termination of early pregnancy in scarred uterus with letrozole and misoprostol compared to Misoprostol alone
Key inclusion criteria (4 listed)
- Minimum age of 18 years for mother.
Key exclusion criteria (3 listed)
- * Medical problem in patient
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 2.5mgMissed abortion received letrozole then misoprostol | Drug | Missed abortion received letrozole then misoprostol |
Primary outcome
Complete abortion of early pregnancy with letrozole then misoprostol
Time frame: 6 months
Letrozole increase cervical ripening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Termination of Early Pregnancy in Scarred Uterus, run by Ahmed Elsayed Aref at 2 sites 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 3 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete abortion of early pregnancy with letrozole then misoprostol (time frame: 6 months). 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 5 Oct 2021.