Abortion, InducedPhase 3NCT02048098
Misoprostol for Second Trimester Termination of Pregnancy
A Phase 3 study testing Vaginal misoprostol and Buccal misoprostol in people with Abortion, Induced, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Induced
- What is being tested?
- Vaginal misoprostol and Buccal misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Dec 2014
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- gestational age between 12-24 weeks
- live fetus
- singleton pregnancy
- Bishop score <5
- no uterine contraction
Who cannot join
- prostaglandin allergy
- a scar in uterus
- uterine abnormality
- premature rupture of membranes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk Universitesi Araştırma Hastanesi
Erzurum, 25240
About this study
Official title: A Comparison Between Vaginal Misoprostol vs. Buccal Misoprostol For Second Trimester Termination of Pregnancy
The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy
- Conditions
- Abortion, Induced
- Being tested
- Vaginal misoprostol, Buccal misoprostol
- Keywords
- misoprostol, Labor, Induced, Pregnancy Trimester, Second, Abortion, Induced
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal misoprostolDrug
Also called Cytotec
400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
Buccal misoprostolDrug
Also called Cytotec
400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
| Study group | Role | What they receive |
|---|---|---|
| Buccal misoprostol | Active comparator | 400 µg buccal misoprostol per 3 hours Receives: Drug: Buccal misoprostol |
| vaginal misoprostol | Active comparator | 400 µg vaginal misoprostol per 3 hours Receives: Drug: Vaginal misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction to fetal expulsion interval
Time elapsed between administration of the first misoprostol dose until expulsion of the fetus
Measured: 15 minutes after fetus delivered
Secondary outcomes (5)
Delivery within 24 hours
Measured: 24 hour
Delivery within 48 hours
Measured: 48 hours
Use of additional interventions
the patients who did not delivered within 48 hours will considered as failed induction and will be offered another method of induction/delivery or to continue same protocol.
Measured: One week
Expected pain before induction and perceived (actual) pain after abortion completed
Expected and perceived pain will be measured by VAS
Measured: within 1 hour after randomisation and after 12 hour after complete abortion/placenta removed
Rate of complete abortion
Measured: 12 hour after fetus and placenta removed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 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 Abortion, InducedStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragıp Atakan Al, Ataturk University
- Investigators
- Ragıp A AL, MD, Principal investigator, Ataturk University Faculty of MedicineÖmer E Yapça, MD, Study chair, Ataturk University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048098
- Sponsor's protocol ID
- atauni9
- Status last verified
- Jan 2015
- First submitted
- 24 Jan 2014
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Al RA, Yapca OE. Vaginal Misoprostol Compared With Buccal Misoprostol for Termination of Second-Trimester Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):593-598. doi: 10.1097/AOG.0000000000000946.
PubMed 26181087
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Vaginal Misoprostol vs. Buccal Misoprostol For Second Trimester Termination of Pregnancy
- ClinicalTrials.gov ID
- NCT02048098
- Acronym / sponsor ID
- atauni9
- Conditions
- Abortion, Induced
- Keywords
- misoprostol, Labor, Induced, Pregnancy Trimester, Second, Abortion, Induced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Jan 2014 (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 purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal misoprostol | Active comparator | Drug: Buccal misoprostol400 µg buccal misoprostol per 3 hours |
| vaginal misoprostol | Active comparator | Drug: Vaginal misoprostol400 µg vaginal misoprostol per 3 hours |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- gestational age between 12-24 weeks
- live fetus
- singleton pregnancy
- Bishop score <5
- no uterine contraction
Key exclusion criteria (4 listed)
- prostaglandin allergy
- a scar in uterus
- uterine abnormality
- premature rupture of membranes
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 |
|---|---|---|
| Vaginal misoprostolAlso: Cytotec400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol. | Drug | vaginal misoprostol |
| Buccal misoprostolAlso: Cytotec400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol. | Drug | Buccal misoprostol |
Primary outcome
Induction to fetal expulsion interval
Time frame: 15 minutes after fetus delivered
Time elapsed between administration of the first misoprostol dose until expulsion of the fetus
5 secondary outcomes
Delivery within 24 hours
Time frame: 24 hour
Delivery within 48 hours
Time frame: 48 hours
Use of additional interventions
Time frame: One week
Expected pain before induction and perceived (actual) pain after abortion completed
Time frame: within 1 hour after randomisation and after 12 hour after complete abortion/placenta removed
Rate of complete abortion
Time frame: 12 hour after fetus and placenta removed
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 Jan 2015.
- Derived from this study: PubMed 26181087Al RA, Yapca OE. Vaginal Misoprostol Compared With Buccal Misoprostol for Termination of Second-Trimester Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):593-598. doi: 10.1097/AOG.0000000000000946.
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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.
Ragıp A AL, MD principal investigator
Ataturk University Faculty of Medicine
Ömer E Yapça, MD study chair
Ataturk University Faculty of Medicine
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 Vaginal misoprostol and Buccal misoprostol in people with Abortion, Induced, run by Ataturk University at 1 site in Turkey (Türkiye).
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 4 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 Jan 2015. 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 Turkey (Türkiye). 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?
Induction to fetal expulsion interval (time frame: 15 minutes after fetus delivered). 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 NCT02048098, 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 Jan 2015.