Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
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| ClinicalTrials.gov Identifier: NCT01615731 |
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Recruitment Status :
Completed
First Posted : June 11, 2012
Results First Posted : January 26, 2015
Last Update Posted : January 23, 2018
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Sponsor:
Stanford University
Collaborator:
Santa Clara Valley Medical Center
Information provided by (Responsible Party):
Kate Ayers Shaw, Stanford University
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Brief Summary:
A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Abortion, Induced | Drug: Mifepristone Other: Hygroscopic cervical dilators Drug: Misoprostol Drug: Intra-amniotic digoxin | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial |
| Study Start Date : | May 2012 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | July 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Mifepristone
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Two sets of dilators
Two sets of osmotic dilators inserted 1 and 2 days pre-op
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Other: Hygroscopic cervical dilators
Dilapan-S osmostic cervical dilators inserted through the internal os
Other Name: Dilapan-S Drug: Misoprostol 400mcg buccal misoprostol 90 minutes pre-op Drug: Intra-amniotic digoxin 1mg digoxin administered intra-amniotically ~24 hours pre-op |
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Experimental: Mifepristone plus one set of dilators
One set of dilators plus mifepristone
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Drug: Mifepristone
200mg Mifepristone orally
Other Name: Danco, Mifeprex Other: Hygroscopic cervical dilators Dilapan-S osmostic cervical dilators inserted through the internal os
Other Name: Dilapan-S Drug: Misoprostol 400mcg buccal misoprostol 90 minutes pre-op Drug: Intra-amniotic digoxin 1mg digoxin administered intra-amniotically ~24 hours pre-op |
Primary Outcome Measures :
- Procedure Time [ Time Frame: Intraoperative Time ]Measured as time from speculum insertion to removal
- Total Procedure Time [ Time Frame: Measured at clinic visits and on OR day, over a 3 day period ]
Secondary Outcome Measures :
- Maximum Cervical Dilation [ Time Frame: Measured intra-operatively ]Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
- Adverse Events (EBL) [ Time Frame: Intraoperatively ]One adverse event: Estimated Blood Loss
- Ease of Procedure by Blinded Surgeon [ Time Frame: Measured Immediately after procedure ]Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.
- Pain Perceived by Patient [ Time Frame: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively) ]Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.
- Overall Patient Experience [ Time Frame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge ]Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.
- Adverse Events [ Time Frame: Intraoperatively and 2 weeks post operatively ]uterine perforation, uterine injury, etc.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- >18 years old
- Viable, Singleton pregnancy
- Voluntarily seeking abortion between 19 and 24wks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
Exclusion Criteria:
- Allergy to misoprostol or mifepristone
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615731
Locations
| United States, California | |
| Santa Clara Valley Medical Center | |
| San Jose, California, United States, 95128 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
Sponsors and Collaborators
Stanford University
Santa Clara Valley Medical Center
Investigators
| Principal Investigator: | Kate A Shaw, MD | Stanford University |
Publications of Results:
| Responsible Party: | Kate Ayers Shaw, Clinical Instructor, Clinical Fellow, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01615731 |
| Other Study ID Numbers: |
SU-05302012-10088 |
| First Posted: | June 11, 2012 Key Record Dates |
| Results First Posted: | January 26, 2015 |
| Last Update Posted: | January 23, 2018 |
| Last Verified: | December 2017 |
Keywords provided by Kate Ayers Shaw, Stanford University:
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Mifepristone Induced Abortion Dilation and Evacuation Cervical preparation Osmotic dilators |
Additional relevant MeSH terms:
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Dilatation, Pathologic Pathological Conditions, Anatomical Digoxin Misoprostol Mifepristone Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Anti-Arrhythmia Agents Cardiotonic Agents Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Protective Agents Abortifacient Agents, Steroidal Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Contraceptive Agents, Hormonal Menstruation-Inducing Agents |