Abortion, MissedPhase 2NCT03148314
Vaginal Misoprostol In Management Of First Trimester Missed Abortion.
A Phase 2 study testing vaginal misoprostol and buccal/sublingual misoprostol in people with Abortion, Missed, run by Assiut University at 1 site in Egypt.
Trial summary
The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Abortion, Missed
- What is being tested?
- vaginal misoprostol and buccal/sublingual misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 Jun 2018
- 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
- single dead fetus up-to 12 weeks.
- no low lying placenta
- no scarred uterus
- no or mild bleeding
- no evidence of infection
- accepting to participate in the study.
Who cannot join
- Advanced hepatic diseases .
- Suspected molar pregnancy
- Ectopic pregnancy or pregnancy of unknown location
- Haemodynamically unstable with significant anaemia ie Hb<10
- Uncontrolled severe asthma
- Chronic adrenal failure
Show all 12Show fewer
- Known or suspected heart disease
- Glaucoma
- Haemoglobinopathies
- Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
- Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
- Patient living in remote areas with difficulty in accessing hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.
The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion
- Conditions
- Abortion, Missed
- Being tested
- vaginal misoprostol, buccal/sublingual misoprostol
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal misoprostolDrug
Also called buccal/sublingual misoprostol
(800µgm.x 2 doses 3 hours).
buccal/sublingual misoprostolDrug
Also called vaginal misoprostol
200 µgm.x4 hrs.x 6 doses
| Study group | Role | What they receive |
|---|---|---|
| hospital- based vaginal misoprostol | Active comparator | hospital- based vaginal misoprostol Receives: Drug: vaginal misoprostol |
| extended low dose oral misoprostol | Active comparator | extended low dose oral misoprostol Receives: Drug: buccal/sublingual misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete abortion (success rate).
Measured: 1 week
Secondary outcomes (2)
Number of misoprostol doses
Measured: 1 week
induction-abortion time
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Jul 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
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 Abortion, MissedStudies 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
- None (open label)
- Enrolment
- 140 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
- NCT03148314
- Sponsor's protocol ID
- VMIS
- Status last verified
- Apr 2024
- First submitted
- 8 May 2017
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PubMed 34061352
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.
- ClinicalTrials.gov ID
- NCT03148314
- Acronym / sponsor ID
- VMIS
- Conditions
- Abortion, Missed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 11 May 2017 (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 world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hospital- based vaginal misoprostol | Active comparator | Drug: vaginal misoprostolhospital- based vaginal misoprostol |
| extended low dose oral misoprostol | Active comparator | Drug: buccal/sublingual misoprostolextended low dose oral misoprostol |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- single dead fetus up-to 12 weeks.
- no low lying placenta
- no scarred uterus
- no or mild bleeding
- no evidence of infection
Key exclusion criteria (12 listed)
- Advanced hepatic diseases .
- Suspected molar pregnancy
- Ectopic pregnancy or pregnancy of unknown location
- Haemodynamically unstable with significant anaemia ie Hb<10
- Uncontrolled severe asthma
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 |
|---|---|---|
| vaginal misoprostolAlso: buccal/sublingual misoprostol(800µgm.x 2 doses 3 hours). | Drug | hospital- based vaginal misoprostol |
| buccal/sublingual misoprostolAlso: vaginal misoprostol200 µgm.x4 hrs.x 6 doses | Drug | extended low dose oral misoprostol |
Primary outcome
Percentage of patients with complete abortion (success rate).
Time frame: 1 week
2 secondary outcomes
Number of misoprostol doses
Time frame: 1 week
induction-abortion time
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 34061352Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
- Individual participant dataSharing planned: Undecided
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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 vaginal misoprostol and buccal/sublingual misoprostol in people with Abortion, Missed, 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 24 Apr 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients with complete abortion (success rate). (time frame: 1 week). 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 NCT03148314, 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 24 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.