MiscarriageNCT05103098
Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
A study testing misoprostol 400 mcg and misoprostol 800 mcg in people with Miscarriage, run by hany farouk at 1 site in Egypt.
Trial summary
The aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Miscarriage
- What is being tested?
- misoprostol 400 mcg and misoprostol 800 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 31 Mar 2023
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women above 18 years of age
- Less than 12 weeks of gestation.
- Pregnancy is confirmed by pregnancy test or ultrasound scan.
- missed abortion
- Normal general and gynecological examination.
Who cannot join
- Hemodynamically unstable.
- Suspected sepsis with temperature 38 °C.
- Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
- respiratory illnesses, recent liver disease, or pruritus of pregnancy.
- Presence of intrauterine contraceptive device (IUCD).
- Suspect or proven ectopic pregnancy.
- Failed medical or surgical evacuation before the presentation.
- Known allergy to misoprostol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Misoprostol 400 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial
The aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.
Read the detailed description
the study will be made on female patients with the first trimester missed abortion confirmed by ultrasound. Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol 400 mcg and the other group(B) will receive sublingual Misoprostol 800 mcg every 4 hours in both groups up to 3 doses the aim of the study is to compare the efficacy of sublingual Misoprostol in complete termination of the first trimester missed abortion and which route is the best will less side effects.
- Conditions
- Miscarriage
- Being tested
- misoprostol 400 mcg, misoprostol 800 mcg
- Keywords
- miscarriage, sublingual, misoprostol
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostol 400 mcgDrug
Also called experimental
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Two doses of misoprostol 400 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
misoprostol 800 mcgDrug
Also called Active Comparator
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
| Study group | Role | What they receive |
|---|---|---|
| misoprostol 400 mcg | Experimental | All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Two doses of misoprostol 800 mcg each (2 tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception Receives: Drug: misoprostol 400 mcg |
| misoprostol 800 mcg | Active comparator | All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home.
Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception Receives: Drug: misoprostol 800 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of abortion
Number of Participants with expulsion of Products of conception by visual inspection
Measured: 7 days
Secondary outcomes (2)
Successful medical abortion
Number of Participants with cervical os is closed with endometrial thickness of less than 15 mm
Measured: 7 days
amount of calculated blood loss following treatment
amount of calculated blood loss
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a double-blind randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- hany farouk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hany farouk, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103098
- Sponsor's protocol ID
- aswu/354/9/19
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Misoprostol 400 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05103098
- Acronym / sponsor ID
- aswu/354/9/19
- Conditions
- Miscarriage
- Keywords
- miscarriage, sublingual, misoprostol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- hany faroukUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 2 Nov 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.
The aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.
Detailed description
the study will be made on female patients with the first trimester missed abortion confirmed by ultrasound. Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol 400 mcg and the other group(B) will receive sublingual Misoprostol 800 mcg every 4 hours in both groups up to 3 doses the aim of the study is to compare the efficacy of sublingual Misoprostol in complete termination of the first trimester missed abortion and which route is the best will less side effects.
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
- a double-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| misoprostol 400 mcg | Experimental | Drug: misoprostol 400 mcgAll patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Two doses of misoprostol 800 mcg each (2 tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception |
| misoprostol 800 mcg | Active comparator | Drug: misoprostol 800 mcgAll patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All women above 18 years of age
- Less than 12 weeks of gestation.
- Pregnancy is confirmed by pregnancy test or ultrasound scan.
- missed abortion
- Normal general and gynecological examination.
Key exclusion criteria (8 listed)
- Hemodynamically unstable.
- Suspected sepsis with temperature 38 °C.
- Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
- respiratory illnesses, recent liver disease, or pruritus of pregnancy.
- Presence of intrauterine contraceptive device (IUCD).
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 400 mcgAlso: experimentalAll patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Two doses of misoprostol 400 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception | Drug | misoprostol 400 mcg |
| misoprostol 800 mcgAlso: Active ComparatorAll patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception | Drug | misoprostol 800 mcg |
Primary outcome
Completeness of abortion
Time frame: 7 days
Number of Participants with expulsion of Products of conception by visual inspection
2 secondary outcomes
Successful medical abortion
Time frame: 7 days
amount of calculated blood loss following treatment
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing misoprostol 400 mcg and misoprostol 800 mcg in people with Miscarriage, run by hany farouk 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 8 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 2 Nov 2021. 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?
Completeness of abortion (time frame: 7 days). 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 2 Nov 2021.