Abortion EarlyPhase 4MisoWetNCT02522078
Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion
A Phase 4 study testing dry misoprostol and wet misoprostol in people with Abortion Early, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- Abortion Early
- What is being tested?
- dry misoprostol and wet misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Feb 2016
- Phase
- Phase 4
- 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 14 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women with abortion (less than 12 weeks of pregnancy)
Who cannot join
- congestive heart failure
- chronic pulmonary disease
- hypovolemic shock
- twins
- Marfan syndrome
- septic abortion (fever, pus , leukocytosis >14,000)
Show all 10Show fewer
- known allergies to misoprostol
- blood dyscrasia
- open cervical (≥ 1cm)
- use of intrauterine device
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
About this study
Official title: Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion - A Clinical Trial
This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol
Read the detailed description
Misoprostol is the most widely used drug for abortion due to its low cost, stability and easy to use regimen. Nevertheless, there is a debate whether the administration of dry misoprostol has similar effects compared to wet pill. It would be necessary to undertake a clinical trial to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine evacuation. The primary objective of this study is to compare the degree of cervical dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3 or more hours before the procedure. Secondary objective is to verify whether there is a correlation between vaginal pH (<5 / ≥5) and the degree of cervical dilation (≥8mm / <8mm) with the use of wet or dry misoprostol. Women will be randomized to one of the two groups: dry or wet misoprostol.
- Conditions
- Abortion Early
- Being tested
- dry misoprostol, wet misoprostol
- Keywords
- misoprostol, abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry misoprostolDrug
400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
wet misoprostolDrug
400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
| Study group | Role | What they receive |
|---|---|---|
| Dry Misoprostol | Active comparator | 400 µg of dry misoprostol Receives: Drug: dry misoprostol |
| Wet misoprostol | Experimental | 400 µg of wet misoprostol Receives: Drug: wet misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical dilation
Cervical dilation will be measure with Karman cannulas
Measured: 3 to 4 hours after putting misoprostol into the vagina
Secondary outcomes (1)
Vaginal acidity - hydrogen ion concentration
at the moment of the introduction of misoprostol into the vagina
Measured: within 2 min before putting the misoprostol into the vagina
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo F Savaris, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522078
- Sponsor's protocol ID
- 15-0115
- Acronym
- MisoWet
- Status last verified
- Mar 2016
- First submitted
- 4 Aug 2015
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
WHO. The Prevention and management of unsafe abortion: report of a technical working group, Geneva, 12-15 April 1992. 1993
Regan L, Rai R. Epidemiology and the medical causes of miscarriage. Baillieres Best Pract Res Clin Obstet Gynaecol. 2000 Oct;14(5):839-54. doi: 10.1053/beog.2000.0123.
PubMed 11023804Grimes DA, Benson J, Singh S, Romero M, Ganatra B, Okonofua FE, Shah IH. Unsafe abortion: the preventable pandemic. Lancet. 2006 Nov 25;368(9550):1908-19. doi: 10.1016/S0140-6736(06)69481-6.
PubMed 17126724Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
PubMed 16581405Neilson JP, Gyte GM, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD007223. doi: 10.1002/14651858.CD007223.pub3.
PubMed 23543549Fong YF, Singh K, Prasad RN. A comparative study using two dose regimens (200 microg or 400 microg) of vaginal misoprostol for pre-operative cervical dilatation in first trimester nulliparae. Br J Obstet Gynaecol. 1998 Apr;105(4):413-7. doi: 10.1111/j.1471-0528.1998.tb10126.x.
PubMed 9609268
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion - A Clinical Trial
- ClinicalTrials.gov ID
- NCT02522078
- Acronym / sponsor ID
- MisoWet / 15-0115
- Conditions
- Abortion Early
- Keywords
- misoprostol, abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Aug 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.
This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol
Detailed description
Misoprostol is the most widely used drug for abortion due to its low cost, stability and easy to use regimen. Nevertheless, there is a debate whether the administration of dry misoprostol has similar effects compared to wet pill. It would be necessary to undertake a clinical trial to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine evacuation. The primary objective of this study is to compare the degree of cervical dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3 or more hours before the procedure. Secondary objective is to verify whether there is a correlation between vaginal pH (<5 / ≥5) and the degree of cervical dilation (≥8mm / <8mm) with the use of wet or dry misoprostol. Women will be randomized to one of the two groups: dry or wet misoprostol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Misoprostol | Active comparator | Drug: dry misoprostol400 µg of dry misoprostol |
| Wet misoprostol | Experimental | Drug: wet misoprostol400 µg of wet misoprostol |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women with abortion (less than 12 weeks of pregnancy)
Key exclusion criteria (10 listed)
- congestive heart failure
- chronic pulmonary disease
- hypovolemic shock
- twins
- Marfan syndrome
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 |
|---|---|---|
| dry misoprostol400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation | Drug | Dry Misoprostol |
| wet misoprostol400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation | Drug | Wet misoprostol |
Primary outcome
Cervical dilation
Time frame: 3 to 4 hours after putting misoprostol into the vagina
Cervical dilation will be measure with Karman cannulas
1 secondary outcome
Vaginal acidity - hydrogen ion concentration
Time frame: within 2 min before putting the misoprostol into the vagina
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 25 Mar 2016.
- BackgroundWHO. The Prevention and management of unsafe abortion: report of a technical working group, Geneva, 12-15 April 1992. 1993
- Background: PubMed 11023804Regan L, Rai R. Epidemiology and the medical causes of miscarriage. Baillieres Best Pract Res Clin Obstet Gynaecol. 2000 Oct;14(5):839-54. doi: 10.1053/beog.2000.0123.
- Background: PubMed 17126724Grimes DA, Benson J, Singh S, Romero M, Ganatra B, Okonofua FE, Shah IH. Unsafe abortion: the preventable pandemic. Lancet. 2006 Nov 25;368(9550):1908-19. doi: 10.1016/S0140-6736(06)69481-6.
- Background: PubMed 16581405Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9.
- Background: PubMed 23543549Neilson JP, Gyte GM, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD007223. doi: 10.1002/14651858.CD007223.pub3.
- Background: PubMed 9609268Fong YF, Singh K, Prasad RN. A comparative study using two dose regimens (200 microg or 400 microg) of vaginal misoprostol for pre-operative cervical dilatation in first trimester nulliparae. Br J Obstet Gynaecol. 1998 Apr;105(4):413-7. doi: 10.1111/j.1471-0528.1998.tb10126.x.
- 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.
Ricardo F Savaris, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dry misoprostol and wet misoprostol in people with Abortion Early, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 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: finished, as of the sponsor's last update on 25 Mar 2016. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Cervical dilation (time frame: 3 to 4 hours after putting misoprostol into the vagina). 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 NCT02522078, which also lists 6 linked publications.
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 25 Mar 2016.