Abortion, TherapeuticPhase 2NCT00310921
A Randomized Study of Cervical Priming With Misoprostol Prior to Elective First Trimester Pregnancy Termination
A Phase 2 study testing Misoprostol in people with Abortion, Therapeutic, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to determine whether misoprostol administered prior to elective first trimester pregnancy has an effect on pain and ease of procedure and complications. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Therapeutic
- What is being tested?
- Misoprostol
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to May 2006
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet the following inclusion criteria: after completion of a full history and physical exam each subject must be judged physically and mentally stable by the enrolling practitioner; subjects must be between 7 and 11 weeks pregnant and desiring termination. Gestation dating must be based on a reliable menstrual history consistent with a bimanual exam or ultrasound. All subjects must give informed consent after the study has been explained.
Who cannot join
- Subject must not have a physical or mental health condition which could be adversely affected by the study drug, including a history of allergy to prostaglandins or, specifically, to misoprostol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente, Department of OB/GYN
San Francisco, California, 94115
About this study
Official title: A Randomized Study of Cervical Priming With Misoprostol Prior to Elective First Trimester Pregnancy Termination: Effects on Pain, Ease of Procedure and Complications
The purpose of this study is to determine whether misoprostol administered prior to elective first trimester pregnancy has an effect on pain and ease of procedure and complications.
Read the detailed description
Previous studies suggest that cervical priming with misoprostol may facilitate vacuum aspiration for first trimester termination by inducing cervical dilation. This medication is used routinely at some abortion clinics, not at all at others and is used sporadically at most Kaiser facilities. The present study is designed to investigate whether the use of misoprostol noticeably improves the clinical experience. We will determine whether use of misoprostol compared with placebo during first trimester abortion 1) positively impacts ratings of pain experienced by the patient, 2) positively impacts physicians' ratings regarding difficulty of the procedure, and 3) reduces complications.
Misoprostol is effective for cervical priming prior to vacuum aspiration for first trimester pregnancy termination.2 Previous studies examined dose3,4, route of administration (oral5 or vaginal6,7) and time interval to allow maximum dilation while limiting side effects and bleeding prior to procedure.8,9,10 There is evidence supporting a specific dose, route and time interval.10 Previous studies also examined amount of bleeding, length of procedure, force used to dilate the cervix, and cervical dilation in mm.10 However, it is unknown whether these statistically significant changes translate into clinically relevant changes. For example, Ngai et al.10 report that the blood loss is significantly decreased. However, the mean blood loss differed at most by 68 ml. It is widely accepted that during surgical procedures a difference of 68 ml of blood will not change the patient's hematocrit or postoperative clinical course. In the same study preoperative baseline cervical dilation was only 1.7 mm different, also found to be statistically significant but there is no evidence that this difference changes the clinical experience for either the physician or the patient. All previous studies reviewed were also performed with the patient under general anesthesia so the patient's perception of pain was not examined. Because the majority of first trimester terminations in the U.S. are done with the patient awake, it is important to consider pain.
- Conditions
- Abortion, Therapeutic
- Being tested
- Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The first assessment will be a Visual Box Scale (VBS) for pain administered while the patient is undergoing the abortion procedure.
Secondary outcomes (1)
After the procedure the physician will estimate the patient's pain using a VBS. The physician will also estimate the ease of the procedure using a different VBS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startMay 2001
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, TherapeuticStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Crossover
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Investigators
- Seth Feigenbaum, M.D., Principal investigator, Kaiser Permanente Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310921
- Sponsor's protocol ID
- CN-00SFeig-04-B
- Status last verified
- Nov 2005
- First submitted
- 3 Apr 2006
- Last updated
- 11 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Cervical Priming With Misoprostol Prior to Elective First Trimester Pregnancy Termination: Effects on Pain, Ease of Procedure and Complications
- ClinicalTrials.gov ID
- NCT00310921
- Acronym / sponsor ID
- CN-00SFeig-04-B
- Conditions
- Abortion, Therapeutic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- May 2001
- Study completion
- May 2006
- First posted
- 5 Apr 2006 (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 determine whether misoprostol administered prior to elective first trimester pregnancy has an effect on pain and ease of procedure and complications.
Detailed description
Previous studies suggest that cervical priming with misoprostol may facilitate vacuum aspiration for first trimester termination by inducing cervical dilation. This medication is used routinely at some abortion clinics, not at all at others and is used sporadically at most Kaiser facilities. The present study is designed to investigate whether the use of misoprostol noticeably improves the clinical experience. We will determine whether use of misoprostol compared with placebo during first trimester abortion 1) positively impacts ratings of pain experienced by the patient, 2) positively impacts physicians' ratings regarding difficulty of the procedure, and 3) reduces complications.
Misoprostol is effective for cervical priming prior to vacuum aspiration for first trimester pregnancy termination.2 Previous studies examined dose3,4, route of administration (oral5 or vaginal6,7) and time interval to allow maximum dilation while limiting side effects and bleeding prior to procedure.8,9,10 There is evidence supporting a specific dose, route and time interval.10 Previous studies also examined amount of bleeding, length of procedure, force used to dilate the cervix, and cervical dilation in mm.10 However, it is unknown whether these statistically significant changes translate into clinically relevant changes. For example, Ngai et al.10 report that the blood loss is significantly decreased. However, the mean blood loss differed at most by 68 ml. It is widely accepted that during surgical procedures a difference of 68 ml of blood will not change the patient's hematocrit or postoperative clinical course. In the same study preoperative baseline cervical dilation was only 1.7 mm different, also found to be statistically significant but there is no evidence that this difference changes the clinical experience for either the physician or the patient. All previous studies reviewed were also performed with the patient under general anesthesia so the patient's perception of pain was not examined. Because the majority of first trimester terminations in the U.S. are done with the patient awake, it is important to consider pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must meet the following inclusion criteria: after completion of a full history and physical exam each subject must be judged physically and mentally stable by the enrolling practitioner; subjects must be between 7 and 11 weeks pregnant and desiring termination. Gestation dating must be based on a reliable menstrual history consistent with a bimanual exam or ultrasound. All subjects must give informed consent after the study has been explained.
Key exclusion criteria (1 listed)
- Subject must not have a physical or mental health condition which could be adversely affected by the study drug, including a history of allergy to prostaglandins or, specifically, to misoprostol.
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 | Drug | – |
Primary outcome
The first assessment will be a Visual Box Scale (VBS) for pain administered while the patient is undergoing the abortion procedure.
1 secondary outcome
After the procedure the physician will estimate the patient's pain using a VBS. The physician will also estimate the ease of the procedure using a different VBS.
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 11 Apr 2007.
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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.
Seth Feigenbaum, M.D. principal investigator
Kaiser Permanente Medical Group, Inc.
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 in people with Abortion, Therapeutic, run by Kaiser Permanente at 1 site in United States.
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 1 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 11 Apr 2007. 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 United States. 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?
The first assessment will be a Visual Box Scale (VBS) for pain administered while the patient is undergoing the abortion procedure.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2007.