Missed AbortionEarly Phase 1NCT05001061
Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion
A Early Phase 1 study testing Misoprostol Pill in people with Missed Abortion, run by Cairo University.
Trial summary
Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Missed Abortion
- What is being tested?
- Misoprostol Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2021to 16 Oct 2021
- Phase
- Early Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with an ultrasound diagnosis of missed abortion < 13 weeks gestation without any clinical criteria of Inevitable abortion.
Who cannot join
- Patients refused the medical treatment.
- Patients have contraindications of the drug (Misoprostol).
- Missed abortion associated with any signs of sepsis
Trial locations and contacts
No sites are listed yet.
About this study
Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion
Read the detailed description
study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.
- Conditions
- Missed Abortion
- Being tested
- Misoprostol Pill
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol PillDrug
sublingual versus vaginal Misoprostol in termination of first trimester missed abortion
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Misoprostol for termination of first trimester missed abortion | Active comparator | Patients diagnosed as first trimester missed abortion will receive sublingual Misoprostol 800 micrograms every 4 hours up to five doses Receives: Drug: Misoprostol Pill |
| Vaginal Misoprostol for termination of first trimester missed abortion | Active comparator | Patients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses Receives: Drug: Misoprostol Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurance of complete abortion within 24 hours with Misoprostol drug
Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion
Measured: Within 24 hours
Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug
Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start3 Aug 2021 (estimated)
- Primary completion15 Oct 2021 (estimated)
- Study completion16 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Missed AbortionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Emam Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001061
- Sponsor's protocol ID
- Misoprostol abortion
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allameh Z, Goharian M, Eslamian M. Effect of misoprostol with and without letrozole on the induction of abortion for women with first-trimester missed abortion. Int J Gynaecol Obstet. 2020 Nov;151(2):214-218. doi: 10.1002/ijgo.13326. Epub 2020 Sep 1.
PubMed 32700359Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: pharmacokinetic profiles, effects on the uterus and side-effects. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S160-7. doi: 10.1016/j.ijgo.2007.09.004. Epub 2007 Oct 26.
PubMed 17963768
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion
- ClinicalTrials.gov ID
- NCT05001061
- Acronym / sponsor ID
- Misoprostol abortion
- Conditions
- Missed Abortion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Aug 2021 (estimated)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 16 Oct 2021 (estimated)
- First posted
- 11 Aug 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.
Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion
Detailed description
study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual Misoprostol for termination of first trimester missed abortion | Active comparator | Drug: Misoprostol PillPatients diagnosed as first trimester missed abortion will receive sublingual Misoprostol 800 micrograms every 4 hours up to five doses |
| Vaginal Misoprostol for termination of first trimester missed abortion | Active comparator | Drug: Misoprostol PillPatients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with an ultrasound diagnosis of missed abortion < 13 weeks gestation without any clinical criteria of Inevitable abortion.
Key exclusion criteria (3 listed)
- Patients refused the medical treatment.
- Patients have contraindications of the drug (Misoprostol).
- Missed abortion associated with any signs of sepsis
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 |
|---|---|---|
| Misoprostol Pillsublingual versus vaginal Misoprostol in termination of first trimester missed abortion | Drug | Sublingual Misoprostol for termination of first trimester missed abortion, Vaginal Misoprostol for termination of first trimester missed abortion |
Primary outcome
The occurance of complete abortion within 24 hours with Misoprostol drug
Time frame: Within 24 hours
Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion
Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug
Time frame: within 24 hours
Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Background: PubMed 32700359Allameh Z, Goharian M, Eslamian M. Effect of misoprostol with and without letrozole on the induction of abortion for women with first-trimester missed abortion. Int J Gynaecol Obstet. 2020 Nov;151(2):214-218. doi: 10.1002/ijgo.13326. Epub 2020 Sep 1.
- Background: PubMed 17963768Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: pharmacokinetic profiles, effects on the uterus and side-effects. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S160-7. doi: 10.1016/j.ijgo.2007.09.004. Epub 2007 Oct 26.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Misoprostol Pill in people with Missed Abortion, run by Cairo University.
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 1 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 11 Aug 2021. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Ahmed Emam (01003304781, emam3882@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurance of complete abortion within 24 hours with Misoprostol drug (time frame: Within 24 hours). The study lists 2 primary outcomes in all. 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 NCT05001061, which also lists 2 linked publications.
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 11 Aug 2021.