First Trimester PregnancyPhase 2NCT01933360
Misoprostol for Cervical Priming Prior to Vacuum Aspiration
A Phase 2 study testing Misoprostol sublingual, 1h, Misoprostol sublingual, 3h and Misoprostol vaginal, 1h in people with First Trimester Pregnancy and Surgical Termination of Pregnancy, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- First Trimester Pregnancy, Surgical Termination of Pregnancy
- What is being tested?
- Misoprostol sublingual, 1h, Misoprostol sublingual, 3h and Misoprostol vaginal, 1h
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2013to Mar 2014
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women opting for first trimester surgical abortion
- nulliparous
- able and willing to provide informed consent
Who cannot join
- unwilling to participate,
- unable to communicate in Swedish and English and
- minors (i.e. women < 18 years of age),
- contraindications to misoprostol
- women with pathological pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Versus Vaginal Misoprostol for Cervical Dilatation 1 or 3 Hours Prior to Surgical Abortion
Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater the risk or bleeding and expulsion of the uterine contents before the surgical evacuation. Sublingual administration seems to give adequate plasma concentration and cervical priming faster than oral or vaginal administration. This may allow a shorter waiting time with maintained efficacy, less side effects and logistic advantages.
- Being tested
- Misoprostol sublingual, 1h, Placebo sublingual,1h, Misoprostol sublingual, 3h, Misoprostol vaginal, 1h, Misoprostol vaginal, 3h
- Keywords
- Misoprostol, First trimester pregnancy, Surgical abortion, Cervical priming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol sublingual, 1hDrug
Also called Misoprostol (Cytotec)
Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy
Placebo sublingual,1hDrug
Placebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy
Misoprostol sublingual, 3hDrug
Misoprostol is administered sublingually, 3 hours prior to surgical termination of early pregnancy
Misoprostol vaginal, 1hDrug
Misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
Misoprostol vaginal, 3hDrug
Misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy
Placebo sublingual, 3hDrug
Placebo for misoprostol is administered sublingually 3 hours prior to surgical termination of early pregnancy
Placebo vaginal, 1hDrug
Placebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
Placebo vaginal, 3hDrug
Placebo for misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol sublingual,1h | Active comparator | Administration of misoprostol sublingually 1h prior to surgery Receives: Drug: Misoprostol sublingual, 1h; Drug: Placebo vaginal, 1h |
| Misoprostol sublingual. 3h | Active comparator | Administration of misoprostol sublingually 3h prior to surgery Receives: Drug: Misoprostol sublingual, 3h; Drug: Placebo vaginal, 3h |
| Misoprostol vaginal,1h | Active comparator | Administration of misoprostol vaginally 1h prior to surgery Receives: Drug: Placebo sublingual,1h; Drug: Misoprostol vaginal, 1h |
| Misoprostol vaginal,3h | Active comparator | Administration of misoprostol vaginally 3h prior to surgery Receives: Drug: Misoprostol vaginal, 3h; Drug: Placebo sublingual, 3h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force needed for cervical dilatation
Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer. Force and time needed for the dilatation is recorded by the tonometer
Measured: Measured at surgery
Secondary outcomes (2)
Cervical diameter
Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer.The largest dilator that can pass through the inner cervical os without any resistance corresponds to the presurgical cervical diameter
Measured: Measured at surgery
Number of Participants with Adverse Events
Any side effects or symptoms such as nausea, vomiting, uterine cramps, expulsion, bleeding, rash, chills, blood pressure etc are recorded continuously from misoprostol administration until to surgery
Measured: Up to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2014
- Study completionMar 2014
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 First Trimester PregnancyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Gemzell Danielsson, Karolinska Institutet
- Investigators
- Kristina Gemzell Danielsson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933360
- Sponsor's protocol ID
- W500M
- Status last verified
- Aug 2014
- First submitted
- 25 Aug 2013
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saav I, Kopp Kallner H, Fiala C, Gemzell-Danielsson K. Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 h prior to surgical abortion: a double-blinded RCT. Hum Reprod. 2015 Jun;30(6):1314-22. doi: 10.1093/humrep/dev071. Epub 2015 Apr 2.
PubMed 25840429
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Versus Vaginal Misoprostol for Cervical Dilatation 1 or 3 Hours Prior to Surgical Abortion
- ClinicalTrials.gov ID
- NCT01933360
- Acronym / sponsor ID
- W500M
- Keywords
- Misoprostol, First trimester pregnancy, Surgical abortion, Cervical priming
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Sep 2013 (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.
Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater the risk or bleeding and expulsion of the uterine contents before the surgical evacuation. Sublingual administration seems to give adequate plasma concentration and cervical priming faster than oral or vaginal administration. This may allow a shorter waiting time with maintained efficacy, less side effects and logistic advantages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Misoprostol sublingual,1h | Active comparator | Drug: Misoprostol sublingual, 1h, Drug: Placebo vaginal, 1hAdministration of misoprostol sublingually 1h prior to surgery |
| Misoprostol sublingual. 3h | Active comparator | Drug: Misoprostol sublingual, 3h, Drug: Placebo vaginal, 3hAdministration of misoprostol sublingually 3h prior to surgery |
| Misoprostol vaginal,1h | Active comparator | Drug: Placebo sublingual,1h, Drug: Misoprostol vaginal, 1hAdministration of misoprostol vaginally 1h prior to surgery |
| Misoprostol vaginal,3h | Active comparator | Drug: Misoprostol vaginal, 3h, Drug: Placebo sublingual, 3hAdministration of misoprostol vaginally 3h prior to surgery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women opting for first trimester surgical abortion
- nulliparous
- able and willing to provide informed consent
Key exclusion criteria (5 listed)
- unwilling to participate,
- unable to communicate in Swedish and English and
- minors (i.e. women < 18 years of age),
- contraindications to misoprostol
- women with pathological pregnancies
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 |
|---|---|---|
| Misoprostol sublingual, 1hAlso: Misoprostol (Cytotec)Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy | Drug | Misoprostol sublingual,1h |
| Placebo sublingual,1hPlacebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy | Drug | Misoprostol vaginal,1h |
| Misoprostol sublingual, 3hMisoprostol is administered sublingually, 3 hours prior to surgical termination of early pregnancy | Drug | Misoprostol sublingual. 3h |
| Misoprostol vaginal, 1hMisoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy | Drug | Misoprostol vaginal,1h |
| Misoprostol vaginal, 3hMisoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy | Drug | Misoprostol vaginal,3h |
| Placebo sublingual, 3hPlacebo for misoprostol is administered sublingually 3 hours prior to surgical termination of early pregnancy | Drug | Misoprostol vaginal,3h |
| Placebo vaginal, 1hPlacebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy | Drug | Misoprostol sublingual,1h |
| Placebo vaginal, 3hPlacebo for misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy | Drug | Misoprostol sublingual. 3h |
Primary outcome
Force needed for cervical dilatation
Time frame: Measured at surgery
Cervical dilation is evaluated at surgery using Hulka dilators connected to a tonometer. Force and time needed for the dilatation is recorded by the tonometer
2 secondary outcomes
Cervical diameter
Time frame: Measured at surgery
Number of Participants with Adverse Events
Time frame: Up to surgery
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 15 Aug 2014.
- Derived from this study: PubMed 25840429Saav I, Kopp Kallner H, Fiala C, Gemzell-Danielsson K. Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 h prior to surgical abortion: a double-blinded RCT. Hum Reprod. 2015 Jun;30(6):1314-22. doi: 10.1093/humrep/dev071. Epub 2015 Apr 2.
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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.
Kristina Gemzell Danielsson, MD, PhD 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 study testing Misoprostol sublingual, 1h, Misoprostol sublingual, 3h and Misoprostol vaginal, 1h in people with First Trimester Pregnancy and Surgical Termination of Pregnancy, run by Karolinska Institutet 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 3 inclusion and 5 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 15 Aug 2014. 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 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?
Force needed for cervical dilatation (time frame: Measured at surgery). 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 NCT01933360, 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 15 Aug 2014.