Abortion, InducedPhase 4NCT02480543
Different Routes of Misoprostol Prior to First Trimester Surgical Abortion
A Phase 4 study testing Misoprostol (cytotec) in people with Abortion, Induced, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
A randomized clinical trial to assess the effectiveness of same-day cervical preparation with oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Induced
- What is being tested?
- Misoprostol (cytotec)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Jul 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients admitted for elective first trimester abortion (termination of pregnancy/ missed abortion) at Wolfson Medical Center, gestational age <13+0 weeks
- Written consent supplied
Who cannot join
- Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)
- Prostaglandin allergy
- Genital infection
- Space-occupying lesion in the endocervical canal
- Prior cervical surgery
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Edith Wolfson Medical Center
Holon
Hadas Ganer Herman, MD, 972526206696, hadassganer@yahoo.com
About this study
Official title: Different Routes of Misoprostol for Same-day Cervical Preparation Prior to First Trimester Surgical Abortion: a Randomized Controlled Trial
A randomized clinical trial to assess the effectiveness of same-day cervical preparation with oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.
- Conditions
- Abortion, Induced
- Being tested
- Misoprostol (cytotec)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol (cytotec)Drug
| Study group | Role | What they receive |
|---|---|---|
| PO Misoprostol | Active comparator | Cervical preparation with per-os (PO) Misoprostol 400 mcg 2-4 hours prior to curettage Receives: Drug: Misoprostol (cytotec) |
| PV Misoprostol | Active comparator | Cervical preparation with per-vagina (PV) Misoprostol 400 mcg 2-4 hours prior to curettage Receives: Drug: Misoprostol (cytotec) |
| Buccal Misoprostol | Active comparator | Cervical preparation with buccal Misoprostol 400 mcg 2-4 hours prior to curettage Receives: Drug: Misoprostol (cytotec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative cervical width in centimeters
- Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width.
Measured: intraoperative
Secondary outcomes (5)
Time required to achieve cervical dilatation
The time in minutes required for dilatation up to a number 10 Hegar
Measured: intraoperative
Ease of cervical dilatation
The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy
Measured: intraoperative
Patient preference
Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable)
Measured: baseline
Adverse effects of medication
Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting)
Measured: baseline
Surgical complications
Complications arising during surgery (perforation, cervical laceration, excess bleeding)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hadas Ganer Herman, Wolfson Medical Center
- Investigators
- Hadas Ganer Herman, MD, Principal investigator, Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480543
- Sponsor's protocol ID
- 0085-15-WOMC
- Status last verified
- Apr 2016
- First submitted
- 20 Jun 2015
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PubMed 34061352
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Routes of Misoprostol for Same-day Cervical Preparation Prior to First Trimester Surgical Abortion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02480543
- Acronym / sponsor ID
- 0085-15-WOMC
- Conditions
- Abortion, Induced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 24 Jun 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.
A randomized clinical trial to assess the effectiveness of same-day cervical preparation with oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PO Misoprostol | Active comparator | Drug: Misoprostol (cytotec)Cervical preparation with per-os (PO) Misoprostol 400 mcg 2-4 hours prior to curettage |
| PV Misoprostol | Active comparator | Drug: Misoprostol (cytotec)Cervical preparation with per-vagina (PV) Misoprostol 400 mcg 2-4 hours prior to curettage |
| Buccal Misoprostol | Active comparator | Drug: Misoprostol (cytotec)Cervical preparation with buccal Misoprostol 400 mcg 2-4 hours prior to curettage |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted for elective first trimester abortion (termination of pregnancy/ missed abortion) at Wolfson Medical Center, gestational age <13+0 weeks
- Written consent supplied
Key exclusion criteria (5 listed)
- Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)
- Prostaglandin allergy
- Genital infection
- Space-occupying lesion in the endocervical canal
- Prior cervical surgery
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 (cytotec) | Drug | Buccal Misoprostol, PO Misoprostol, PV Misoprostol |
Primary outcome
Preoperative cervical width in centimeters
Time frame: intraoperative
• Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width.
5 secondary outcomes
Time required to achieve cervical dilatation
Time frame: intraoperative
Ease of cervical dilatation
Time frame: intraoperative
Patient preference
Time frame: baseline
Adverse effects of medication
Time frame: baseline
Surgical complications
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Derived from this study: PubMed 34061352Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
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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.
Hadas Ganer Herman, MD principal investigator
Edith Wolfson Medical Center
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 Misoprostol (cytotec) in people with Abortion, Induced, run by Wolfson Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Apr 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadas Ganer Herman, MD (972-077-2066960, hadassganer@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative cervical width in centimeters (time frame: intraoperative). 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 NCT02480543, 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 29 Apr 2016.