Missed AbortionPhase 3NCT02686840
Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage
A Phase 3 study testing sublingual misoprostol and vaginal misoprostol in people with Missed Abortion, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of 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
- Missed Abortion
- What is being tested?
- sublingual misoprostol and vaginal misoprostol
- 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
- Jan 2016to Mar 2017
- Phase
- Phase 3
- 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.
- The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy
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 presentation.
- Known allergy to misoprostol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.
The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.
Read the detailed description
In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.
- Conditions
- Missed Abortion
- Being tested
- sublingual misoprostol, vaginal 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.
sublingual misoprostolDrug
Also called Misotac
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 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 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
vaginal misoprostolDrug
Also called Misotac
All patients will receive three doses of vaginal 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 second dose will be given upon sending home.
Paracetamol, eight hourly, will be provided as analgesic or antipyretic
| Study group | Role | What they receive |
|---|---|---|
| sublingual misoprostol | Experimental | Group A (100 patients): will be treated with sublingual misoprostol Receives: Drug: sublingual misoprostol |
| vaginal misoprostol | Active comparator | Group B (100 patients): will be treated with vaginal misoprostol Receives: Drug: vaginal misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection
Measured: 7 days
Secondary outcomes (5)
Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm
Measured: 7 days
Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation.
Measured: 7 days
Bleeding pattern following treatment
This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding
Measured: 7 days
Pain resulting from the procedure
this will be assessed by the doses of paracetamol given in mg
Measured: 7 days
Additional uterotonic used
additional misoprostol doses in mcg
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 posted22 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionMar 2017
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 Missed AbortionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Shafy El Shahawy, Ain Shams University
- Investigators
- Hassan A Bayoumy, MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686840
- Sponsor's protocol ID
- ASUMH
- Status last verified
- Aug 2017
- First submitted
- 27 Jan 2016
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Abdelshafy A, Awwad H, Abo-Gamra A, Alanwar A, Elkotb AM, Shahin M, Abd El-Razek M, Abbas AM. Sublingual vs vaginal misoprostol for completion of first trimester missed abortion: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2019 Apr;24(2):134-139. doi: 10.1080/13625187.2019.1569224. Epub 2019 Feb 12.
PubMed 30747547
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02686840
- Acronym / sponsor ID
- ASUMH
- Conditions
- Missed Abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Feb 2016 (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.
The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.
Detailed description
In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sublingual misoprostol | Experimental | Drug: sublingual misoprostolGroup A (100 patients): will be treated with sublingual misoprostol |
| vaginal misoprostol | Active comparator | Drug: vaginal misoprostolGroup B (100 patients): will be treated with vaginal misoprostol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 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 (7 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).
- Suspect or proven ectopic pregnancy.
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 |
|---|---|---|
| sublingual misoprostolAlso: MisotacAll 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 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 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 | sublingual misoprostol |
| vaginal misoprostolAlso: MisotacAll patients will receive three doses of vaginal 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 second dose will be given upon sending home. Paracetamol, eight hourly, will be provided as analgesic or antipyretic | Drug | vaginal misoprostol |
Primary outcome
Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection
Time frame: 7 days
5 secondary outcomes
Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm
Time frame: 7 days
Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation.
Time frame: 7 days
Bleeding pattern following treatment
Time frame: 7 days
Pain resulting from the procedure
Time frame: 7 days
Additional uterotonic used
Time frame: 7 days
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 16 Aug 2017.
- Derived from this study: PubMed 30747547Abdelshafy A, Awwad H, Abo-Gamra A, Alanwar A, Elkotb AM, Shahin M, Abd El-Razek M, Abbas AM. Sublingual vs vaginal misoprostol for completion of first trimester missed abortion: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2019 Apr;24(2):134-139. doi: 10.1080/13625187.2019.1569224. Epub 2019 Feb 12.
- 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.
Hassan A Bayoumy, MD study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sublingual misoprostol and vaginal misoprostol in people with Missed Abortion, run by Ain Shams 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 7 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 16 Aug 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection (time frame: 7 days). 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 NCT02686840, 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 16 Aug 2017.