MiscarriageNCT05088707
Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage
A study testing sublingual misoprostol and vaginal misoprostol in people with Miscarriage, run by Aswan University Hospital 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 the second 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?
- 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
- 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
- between 13-26 weeks of gestation.
- Pregnancy is confirmed by a 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 Versus Vaginal Misoprostol In Medical Treatment of Second 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 the second trimester missed miscarriage
Read the detailed description
In women with second trimester-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage.
- Conditions
- Miscarriage
- Being tested
- sublingual misoprostol, vaginal misoprostol
- Keywords
- miscarriage, sublingual, vaginal, 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.
sublingual misoprostolDrug
Also called experimental
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 Active Comparator
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 the 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 | 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: sublingual misoprostol |
| vaginal misoprostol | Active comparator | 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 the second dose will be given upon sending home.
Paracetamol, eight hourly, will be provided as analgesic or antipyretic 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 by visual inspection
Measured: 7 days
Secondary outcomes (2)
Successful medical abortion
cervical os is closed with endometrial thickness of less than 15 mm
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 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
- an open-label randomized controlled study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088707
- Sponsor's protocol ID
- aswu/354/3/18
- Status last verified
- Oct 2021
- First submitted
- 10 Oct 2021
- Last updated
- 22 Oct 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 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05088707
- Acronym / sponsor ID
- aswu/354/3/18
- Conditions
- Miscarriage
- Keywords
- miscarriage, sublingual, vaginal, misoprostol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 22 Oct 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 vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage
Detailed description
In women with second trimester-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an open-label randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| sublingual misoprostol | Experimental | Drug: sublingual misoprostolAll 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 |
| vaginal misoprostol | Active comparator | Drug: vaginal misoprostolAll 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 the second dose will be given upon sending home. Paracetamol, eight hourly, will be provided as analgesic or antipyretic |
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
- between 13-26 weeks of gestation.
- Pregnancy is confirmed by a 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 |
|---|---|---|
| sublingual misoprostolAlso: experimentalAll 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: Active ComparatorAll 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 the 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
Time frame: 7 days
expulsion of Products of conception by visual inspection
2 secondary outcomes
Successful medical abortion
Time frame: 7 days
Bleeding pattern 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 22 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Miscarriage
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Recruiting
The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
Early Pregnancy Bleeding
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Not yet recruitingPhase 3
Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sublingual misoprostol and vaginal misoprostol in people with Miscarriage, run by Aswan University Hospital 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 22 Oct 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?
Contact Hany F Sallam, md (+201112505221 ext. 002, hanysallam876@yahoo.com), or a site near the patient. 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 22 Oct 2021.