PainPhase 3NCT00997074
Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion
A Phase 3 study testing ibuprofen in people with Pain and Pregnancy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks, in regard to the effect on pain relief and the overall procedure success. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Oct 2010
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health
- Pregnancy of up to 7 weeks gestation.
- Approval from the Ministry of Health committee for termination of pregnancy after an intrauterine pregnancy was demonstrated by an ultrasound exam.
- Subjects that provided informed consent and agree to comply with all study procedures.
Who cannot join
- Known allergy to mifepristone, misoprostol, paracetamol or NSAIDs.
- Severe anemia.
- Drug or alcohol abuse
- Known abnormal liver function (liver function tests greater than 1.5 times upper range of normal).
- Known abnormal renal function (serum creatinine > 1.5 mg/dl).
- Abnormal blood tests
Show all 9Show fewer
- Exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect.
- Chronic disease
- Patient is participating currently in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion: A Double-blind Randomized Placebo Controlled Study
In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks, in regard to the effect on pain relief and the overall procedure success.
expected results:
The prophylactic use of NSAIDs could offer significant pain relief and thereby a reduction in the need for additional pain relievers compared to the placebo, without interfering with the outcome of medical abortion
- Being tested
- ibuprofen
- Keywords
- pain after abortion, abortion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofenDrug
Also called ibuprofen - Nonsteroidal anti-inflammatory drugs (NSAIDs)
The most common side effect observed during medical abortion using mifepristone together with misoprostol is abdominal pain. The use of ibuprofen was not shown to interfere with the action of misoprostol to induce uterine contractions and pregnancy expulsion.
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen | Experimental | the group will receive 2 tablets of ibuprofen 400 mg at the time of misoprostol administration. The information about the effect of the analgesics on the pain, and on the course of medical abortion, will be prospectively gathered from questionnaires completed by the study participants Receives: Drug: ibuprofen |
| placebo | No intervention | this group will receive 2 placebo tablets together with the misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).
Measured: 2 weeks
Secondary outcomes (1)
• Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Daniel Seidman, Sheba Medical Center
- Investigators
- Daniel Seidman, Prof., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997074
- Sponsor's protocol ID
- SHEBA-09-7253-DS-CTIL
- Status last verified
- Feb 2012
- First submitted
- 15 Oct 2009
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Avraham S, Gat I, Duvdevani NR, Haas J, Frenkel Y, Seidman DS. Pre-emptive effect of ibuprofen versus placebo on pain relief and success rates of medical abortion: a double-blind, randomized, controlled study. Fertil Steril. 2012 Mar;97(3):612-5. doi: 10.1016/j.fertnstert.2011.12.041. Epub 2012 Jan 20.
PubMed 22265034Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. Pain management for medical abortion before 14 weeks' gestation. Cochrane Database Syst Rev. 2022 May 13;5(5):CD013525. doi: 10.1002/14651858.CD013525.pub2.
PubMed 35553047
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion: A Double-blind Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00997074
- Acronym / sponsor ID
- SHEBA-09-7253-DS-CTIL
- Keywords
- pain after abortion, abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Oct 2009 (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.
In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks, in regard to the effect on pain relief and the overall procedure success.
expected results:
The prophylactic use of NSAIDs could offer significant pain relief and thereby a reduction in the need for additional pain relievers compared to the placebo, without interfering with the outcome of medical abortion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ibuprofen | Experimental | Drug: ibuprofenthe group will receive 2 tablets of ibuprofen 400 mg at the time of misoprostol administration. The information about the effect of the analgesics on the pain, and on the course of medical abortion, will be prospectively gathered from questionnaires completed by the study participants |
| placebo | No intervention | –this group will receive 2 placebo tablets together with the misoprostol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good general health
- Pregnancy of up to 7 weeks gestation.
- Approval from the Ministry of Health committee for termination of pregnancy after an intrauterine pregnancy was demonstrated by an ultrasound exam.
- Subjects that provided informed consent and agree to comply with all study procedures.
Key exclusion criteria (9 listed)
- Known allergy to mifepristone, misoprostol, paracetamol or NSAIDs.
- Severe anemia.
- Drug or alcohol abuse
- Known abnormal liver function (liver function tests greater than 1.5 times upper range of normal).
- Known abnormal renal function (serum creatinine > 1.5 mg/dl).
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 |
|---|---|---|
| ibuprofenAlso: ibuprofen - Nonsteroidal anti-inflammatory drugs (NSAIDs)The most common side effect observed during medical abortion using mifepristone together with misoprostol is abdominal pain. The use of ibuprofen was not shown to interfere with the action of misoprostol to induce uterine contractions and pregnancy expulsion. | Drug | ibuprofen |
Primary outcome
• Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).
Time frame: 2 weeks
1 secondary outcome
• Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded.
Time frame: 2 weeks
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 17 Feb 2012.
- Results publication: PubMed 22265034Avraham S, Gat I, Duvdevani NR, Haas J, Frenkel Y, Seidman DS. Pre-emptive effect of ibuprofen versus placebo on pain relief and success rates of medical abortion: a double-blind, randomized, controlled study. Fertil Steril. 2012 Mar;97(3):612-5. doi: 10.1016/j.fertnstert.2011.12.041. Epub 2012 Jan 20.
- Derived from this study: PubMed 35553047Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. Pain management for medical abortion before 14 weeks' gestation. Cochrane Database Syst Rev. 2022 May 13;5(5):CD013525. doi: 10.1002/14651858.CD013525.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.
Daniel Seidman, Prof. principal investigator
Sheba 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 3 study testing ibuprofen in people with Pain and Pregnancy, run by Sheba 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 4 inclusion and 9 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 17 Feb 2012. 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 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?
• Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain). (time frame: 2 weeks). 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 NCT00997074, which also lists 2 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 17 Feb 2012.