Legally Induced Abortion Without Mention of ComplicationPOEMNCT01862991
Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services
A study testing Hygroscopic cervical dilators, Misoprostol and Intra-amniotic digoxin in people with Legally Induced Abortion Without Mention of Complication, run by Stanford University at 2 sites in United States.
Trial summary
This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Legally Induced Abortion Without Mention of Complication
- What is being tested?
- Hygroscopic cervical dilators, Misoprostol and Intra-amniotic digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- Viable, Singleton pregnancy
- Voluntarily seeking abortion between 19 and 24 wks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
Who cannot join
- Allergy to misoprostol or mifepristone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Santa Clara Valley Medical Center
San Jose, California, 95128
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services
This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.
- Being tested
- Hygroscopic cervical dilators, Misoprostol, Intra-amniotic digoxin, Mifepristone
- Keywords
- Induced Abortion, Mifepristone, Dilation and Evacuation, Cervical Preparation, Osmotic Dilators
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hygroscopic cervical dilatorsOther
Also called Dilapan-S
Dilapan-S osmotic cervical dilators inserted through the internal os.
MisoprostolDrug
400 mcg buccal misoprostol 90 pre-op
Intra-amniotic digoxinDrug
1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
MifepristoneDrug
Also called Danco, Mifeprex
200 mcg Mifepristone orally
| Study group | Role | What they receive |
|---|---|---|
| Dilapan-Placebo | Placebo comparator | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Receives: Other: Hygroscopic cervical dilators; Drug: Misoprostol; Drug: Intra-amniotic digoxin |
| Dilapan-Mifepristone | Active comparator | The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Receives: Other: Hygroscopic cervical dilators; Drug: Misoprostol; Drug: Intra-amniotic digoxin; Drug: Mifepristone |
| Mifepristone | Experimental | The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. Receives: Drug: Misoprostol; Drug: Intra-amniotic digoxin; Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Time
Measured as time from speculum insertion to removal
Measured: Intraoperative Time, Collected immediately within procedure
Secondary outcomes (1)
Adverse Events
Uterine perforation
Measured: Intraoperatively and 2 weeks post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Legally Induced Abortion Without Mention of ComplicationStudies of the same condition, open and under way.
- More trials run by Stanford 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Clara Valley Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862991
- Sponsor's protocol ID
- SU-05132013-108659
- Other IDs
- PF-108666
- Acronym
- POEM
- Status last verified
- Jan 2024
- First submitted
- 22 May 2013
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services
- ClinicalTrials.gov ID
- NCT01862991
- Acronym / sponsor ID
- POEM / SU-05132013-108659
- Keywords
- Induced Abortion, Mifepristone, Dilation and Evacuation, Cervical Preparation, Osmotic Dilators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Santa Clara Valley Medical Center
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 May 2013 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dilapan-Placebo | Placebo comparator | Other: Hygroscopic cervical dilators, Drug: Misoprostol, Drug: Intra-amniotic digoxinThe clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. |
| Dilapan-Mifepristone | Active comparator | Other: Hygroscopic cervical dilators, Drug: Misoprostol, Drug: Intra-amniotic digoxin, Drug: MifepristoneThe clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. |
| Mifepristone | Experimental | Drug: Misoprostol, Drug: Intra-amniotic digoxin, Drug: MifepristoneThe patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old
- Viable, Singleton pregnancy
- Voluntarily seeking abortion between 19 and 24 wks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
Key exclusion criteria (1 listed)
- Allergy to misoprostol or mifepristone
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 |
|---|---|---|
| Hygroscopic cervical dilatorsAlso: Dilapan-SDilapan-S osmotic cervical dilators inserted through the internal os. | Other | Dilapan-Mifepristone, Dilapan-Placebo |
| Misoprostol400 mcg buccal misoprostol 90 pre-op | Drug | Dilapan-Mifepristone, Dilapan-Placebo, Mifepristone |
| Intra-amniotic digoxin1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation | Drug | Dilapan-Mifepristone, Dilapan-Placebo, Mifepristone |
| MifepristoneAlso: Danco, Mifeprex200 mcg Mifepristone orally | Drug | Dilapan-Mifepristone, Mifepristone |
Primary outcome
Procedure Time
Time frame: Intraoperative Time, Collected immediately within procedure
Measured as time from speculum insertion to removal
1 secondary outcome
Adverse Events
Time frame: Intraoperatively and 2 weeks post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hygroscopic cervical dilators, Misoprostol and Intra-amniotic digoxin in people with Legally Induced Abortion Without Mention of Complication, run by Stanford University at 2 sites 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 5 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Procedure Time (time frame: Intraoperative Time, Collected immediately within 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 14 Feb 2024.