Missed AbortionPhase 2/3NCT01615224
Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage
A Phase 2/3 study testing misoprostol in people with Missed Abortion, run by Kristina Gemzell Danielsson at 1 site in Sweden.
Trial summary
Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Missed Abortion
- What is being tested?
- misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- May 2012to 30 Oct 2019
- Phase
- Phase 2/3
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus
Who cannot join
- empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Obstetrics and Gynecology, Danderyd Hospital
Stockholm, 18288
About this study
Official title: Repeated Doses of Misoprostol for Treatment of Missed Abortion
Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.
- Conditions
- Missed Abortion
- Being tested
- misoprostol
- Keywords
- missed abortion, miscarriage
- Medical subject headings
- Abortion, Missed, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
Also called Cytotec 200mcg Pfizer
repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.
| Study group | Role | What they receive |
|---|---|---|
| single dose | No intervention | Patients receive the standard treatment with 800mcg of vaginal misoprostol |
| repeated doses | Experimental | patients receive 800mcg of vaginal misoprostol. In addition to this they receive repeated doses of 400mcg oral misoprostol after 3 and 5 hours. Women of more than 9 weeks pregnancy according to last menstrual period will be given a choice of vacuum aspiration or further medical treatment with 2 additional doses of misoprostol given after 7 and 9 hours after the initial vaginal treatment. Receives: Drug: misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Complete abortion as judged by ultrasound
Measured: 1 day
Secondary outcomes (1)
Acceptability
questionnaire on future choice of treatment method. Surgical or medical treatment if free choice. If having to have medical would she choose repeated doses or single dose?
Measured: 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMay 2012
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Why it stopped: No funding
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristina Gemzell Danielsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristina Gemzell Danielsson, Karolinska Institutet
- Investigators
- Kristina Gemzell Danielsson, professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615224
- Sponsor's protocol ID
- WMA11
- Status last verified
- Aug 2019
- First submitted
- 4 Jun 2012
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Doses of Misoprostol for Treatment of Missed Abortion
- ClinicalTrials.gov ID
- NCT01615224
- Acronym / sponsor ID
- WMA11
- Conditions
- Missed Abortion
- Keywords
- missed abortion, miscarriage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funding
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Kristina Gemzell DanielssonUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 8 Jun 2012 (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.
Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single dose | No intervention | –Patients receive the standard treatment with 800mcg of vaginal misoprostol |
| repeated doses | Experimental | Drug: misoprostolpatients receive 800mcg of vaginal misoprostol. In addition to this they receive repeated doses of 400mcg oral misoprostol after 3 and 5 hours. Women of more than 9 weeks pregnancy according to last menstrual period will be given a choice of vacuum aspiration or further medical treatment with 2 additional doses of misoprostol given after 7 and 9 hours after the initial vaginal treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus
Key exclusion criteria (1 listed)
- empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment
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 |
|---|---|---|
| misoprostolAlso: Cytotec 200mcg Pfizerrepeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours. | Drug | repeated doses |
Primary outcome
Efficacy
Time frame: 1 day
Complete abortion as judged by ultrasound
1 secondary outcome
Acceptability
Time frame: 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks
Results and safety
The study was stopped early (reason given: No funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
Related trials for Missed Abortion
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
RecruitingObservational study
Periodontal Pathogens and Inflammatory Biomarkers in Missed Abortion
Missed Abortion, Periodontitis
Not yet recruiting
GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion
Missed Abortion, Early Pregnancy Loss
Not yet recruiting
The Value of Pretreatment With Letrozole on Induction Time of Medical Evacuation With Misoprostol in Cases of Missed Abortion
Letrozole
Not yet recruitingPhase 1
Comparison of Efficacy and Safety of Oral Versus Vaginal Misoprostol in Missed Abortion in First Trimester of Pregnancy
Missed Abortion
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.
Kristina Gemzell Danielsson, professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing misoprostol in people with Missed Abortion, run by Kristina Gemzell Danielsson at 1 site in Sweden.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Dec 2019. 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 Sweden. 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 combined 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.
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 was stopped early (reason given: No funding). 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?
Efficacy (time frame: 1 day). 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 18 Dec 2019.