Missed AbortionPhase 2NCT02573051
Termination Of Anembryonic Pregnancy
A Phase 2 study testing Misoprostol and Isosorbide mononitrate in people with Missed Abortion, run by Assiut University at 1 site in Egypt.
Trial summary
Anembryonic pregnancy is a leading cause of early miscarriage. The American Pregnancy Association estimates that blighted ovum causes approximately 50 percent of all first-trimester miscarriages. About 20 percent of all pregnancies result in miscarriage. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Missed Abortion
- What is being tested?
- Misoprostol and Isosorbide mononitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2015to 1 Dec 2015
- Phase
- Phase 2
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age ≥20years old.
- No vaginal bleeding.
- No dilation of internal os.
- Gestational age: from 8-11weeks.
- Gestational sac with a mean gestational sac diameter (MGD) greater than 25 mm and no yolk sac, or an MGD >25 mm with no embryo.
Who cannot join
- Patients with excessive vaginal bleeding (soaking more than a pad per day).
- Patients with dilated cervix.
- Patients with allergy either to misoprostol or isosorbide mononitrate.
- Those who will be insisted on D and C will be excluded from the study.
- Women will be excluded from the study if they are anemic (hemoglobin less than 11 g/dl).
- Hemo-dynamically unstable with signs of pelvic infection and/or sepsis.
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- Suffering from a clotting disorder or using anticoagulants.
- Women with uterine pathology such as myomas or malformation.
- Women had previous caesarian section.
- Asthmatic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Misoprostol Plus Isosorbide Mononitrate Versus Misoprostol For Termination Of Anembryonic Pregnancy
Anembryonic pregnancy is a leading cause of early miscarriage. The American Pregnancy Association estimates that blighted ovum causes approximately 50 percent of all first-trimester miscarriages. About 20 percent of all pregnancies result in miscarriage.
In general, there are 3 options for management of anembryonic pregnancy: expectant, medical, and surgical management. Expectant management consists of no intervention and awaiting natural passage of tissue. Medical management uses medication to expel uterine tissue. Surgical management is defined by mechanical removal of tissue from the uterus.
Read more
Medical management allows patients to avoid surgery and anesthesia. Patients may also feel that medical management is more private, and under their control. Several medications have been studied for medical management.
Misoprostol, a prostaglandin E1 analogue, is a uterotonic that results in cervical softening and contractions that expel the products of conception. It may be administered vaginally, orally, buccally, or sublingually. Adverse effects vary based on route of administration.
There is published literature on a wide range of therapeutic misoprostol regimens. Optimal dose and route of administration of misoprostol have not been determined by randomized trials. Overall, misoprostol is safe and well-tolerated.
Patients receiving misoprostol vaginally rather than orally have decreased adverse gastrointestinal effects and prolonged duration of action.
Oral misoprostol is less effective than vaginal misoprostol in emptying the uterus. Sublingual misoprostol is equivalent to vaginal misoprostol in inducing complete uterine emptying but is associated with more frequent diarrhea.
When compared with lower dosages, a dose of 800 µg vaginal misoprostol is more effective at completing uterine emptying, although it results in a similar incidence of nausea. Based on international trials in settings with limited resources, WHO recommends a single vaginal dose of 800 µg misoprostol for medical management of anembryonic pregnancy. Routes of misoprostol administration include oral, vaginal, buccal or rectal. Vaginal misoprostol is associated with a greater overall exposure to the drug and greater effects on the cervix and uterus.
Isosorbide mononitrate (IMN) is a drug used principally in the treatment of angina pectoris, which acts by dilating the blood vessels so as to reduce blood pressure.
- Conditions
- Missed Abortion
- Being tested
- Misoprostol, Isosorbide mononitrate, 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.
MisoprostolDrug
800 µg of misoprostol (Misotac 200 µg Sigma for Pharmaceutical Industries)
Isosorbide mononitrateDrug
40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company)
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol plus isosorbide mononitrate | Active comparator | this group will receive 800 µg of misoprostol (Misotac 200 µg Sigma for Pharmaceutical Industries) plus 40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company) will be inserted into the posterior vaginal fornix Receives: Drug: Misoprostol; Drug: Isosorbide mononitrate |
| Misoprostol plus placebo | Active comparator | This group will receive misoprostol 800 µg plus placebo in the same site. Receives: Drug: Misoprostol; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of endometrial thickness by ultrasound in mm
Complete expulsion of remnant of conception is considered if endometrial thickness less than 10 mm and if more than 10 mm it considered incomplete expulsion.
Measured: 6 months
Secondary outcomes (3)
Induction - abortion interval in hours
The period from the start of administration of misoprostol until complete abortion
Measured: 6 months
Induction dilatation interval in hours
The period from the start of administration of misoprostol until the start of cervical dilatation measured during per vagina (P/V) examination
Measured: 6 month
The occurrence of sever uncontrolled lower abdominal pain by visual analogue scale
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 posted9 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015 (estimated)
- Study completion1 Dec 2015
Why it stopped: no participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed AbortionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573051
- Sponsor's protocol ID
- ANP
- Status last verified
- Jul 2024
- First submitted
- 8 Oct 2015
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol Plus Isosorbide Mononitrate Versus Misoprostol For Termination Of Anembryonic Pregnancy
- ClinicalTrials.gov ID
- NCT02573051
- Acronym / sponsor ID
- ANP
- Conditions
- Missed Abortion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 9 Oct 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.
Anembryonic pregnancy is a leading cause of early miscarriage. The American Pregnancy Association estimates that blighted ovum causes approximately 50 percent of all first-trimester miscarriages. About 20 percent of all pregnancies result in miscarriage.
In general, there are 3 options for management of anembryonic pregnancy: expectant, medical, and surgical management. Expectant management consists of no intervention and awaiting natural passage of tissue. Medical management uses medication to expel uterine tissue. Surgical management is defined by mechanical removal of tissue from the uterus.
Medical management allows patients to avoid surgery and anesthesia. Patients may also feel that medical management is more private, and under their control. Several medications have been studied for medical management.
Misoprostol, a prostaglandin E1 analogue, is a uterotonic that results in cervical softening and contractions that expel the products of conception. It may be administered vaginally, orally, buccally, or sublingually. Adverse effects vary based on route of administration.
There is published literature on a wide range of therapeutic misoprostol regimens. Optimal dose and route of administration of misoprostol have not been determined by randomized trials. Overall, misoprostol is safe and well-tolerated.
Patients receiving misoprostol vaginally rather than orally have decreased adverse gastrointestinal effects and prolonged duration of action.
Oral misoprostol is less effective than vaginal misoprostol in emptying the uterus. Sublingual misoprostol is equivalent to vaginal misoprostol in inducing complete uterine emptying but is associated with more frequent diarrhea.
When compared with lower dosages, a dose of 800 µg vaginal misoprostol is more effective at completing uterine emptying, although it results in a similar incidence of nausea. Based on international trials in settings with limited resources, WHO recommends a single vaginal dose of 800 µg misoprostol for medical management of anembryonic pregnancy. Routes of misoprostol administration include oral, vaginal, buccal or rectal. Vaginal misoprostol is associated with a greater overall exposure to the drug and greater effects on the cervix and uterus.
Isosorbide mononitrate (IMN) is a drug used principally in the treatment of angina pectoris, which acts by dilating the blood vessels so as to reduce blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol plus isosorbide mononitrate | Active comparator | Drug: Misoprostol, Drug: Isosorbide mononitratethis group will receive 800 µg of misoprostol (Misotac 200 µg Sigma for Pharmaceutical Industries) plus 40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company) will be inserted into the posterior vaginal fornix |
| Misoprostol plus placebo | Active comparator | Drug: Misoprostol, Other: placeboThis group will receive misoprostol 800 µg plus placebo in the same site. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Maternal age ≥20years old.
- No vaginal bleeding.
- No dilation of internal os.
- Gestational age: from 8-11weeks.
- Gestational sac with a mean gestational sac diameter (MGD) greater than 25 mm and no yolk sac, or an MGD >25 mm with no embryo.
Key exclusion criteria (10 listed)
- Patients with excessive vaginal bleeding (soaking more than a pad per day).
- Patients with dilated cervix.
- Patients with allergy either to misoprostol or isosorbide mononitrate.
- Those who will be insisted on D and C will be excluded from the study.
- Women will be excluded from the study if they are anemic (hemoglobin less than 11 g/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 |
|---|---|---|
| Misoprostol800 µg of misoprostol (Misotac 200 µg Sigma for Pharmaceutical Industries) | Drug | Misoprostol plus isosorbide mononitrate, Misoprostol plus placebo |
| Isosorbide mononitrate40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company) | Drug | Misoprostol plus isosorbide mononitrate |
| placebo | Other | Misoprostol plus placebo |
Primary outcome
The measurement of endometrial thickness by ultrasound in mm
Time frame: 6 months
Complete expulsion of remnant of conception is considered if endometrial thickness less than 10 mm and if more than 10 mm it considered incomplete expulsion.
3 secondary outcomes
Induction - abortion interval in hours
Time frame: 6 months
Induction dilatation interval in hours
Time frame: 6 month
The occurrence of sever uncontrolled lower abdominal pain by visual analogue scale
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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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 Phase 2 study testing Misoprostol and Isosorbide mononitrate in people with Missed Abortion, run by Assiut 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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 31 Jul 2024. 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.
What does this 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
The measurement of endometrial thickness by ultrasound in mm (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 31 Jul 2024.