Abortion, InducedNCT01751087
Cervical Preparation Before Dilation and Evacuation
A study testing Mifepristone, misoprostol and Osmotic dilators in people with Abortion, Induced, run by Planned Parenthood League of Massachusetts at 7 sites in United States.
Trial summary
The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion. Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix Osmotic dilators plus mifepristone, a medicine that is swallowed Osmotic… 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?
- Mifepristone, misoprostol and Osmotic dilators
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2013to Jun 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Able to give informed consent
- Medically eligible for outpatient second trimester pregnancy termination at the clinical site
- English-speaking or Spanish-speaking at sites with ability to obtain informed consent in Spanish
Who cannot join
- Active bleeding (>1 pad/hour) or hemodynamically unstable at enrollment
- Signs of chorioamnionitis or clinical infection at enrollment
- Signs of spontaneous labor or cervical insufficiency at enrollment
- Spontaneous intrauterine fetal demise
- Patient incarcerated
- Allergy to mifepristone or misoprostol
Show all 9Show fewer
- Chronic steroid use or adrenal insufficiency
- Porphyria
- Inflammatory bowel disease requiring treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Family Planning Associates
Chicago, Illinois, 60630
Planned Parenthood of New York City
New York, New York, 10012
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Lovejoy Surgical Center
Portland, Oregon, 97210
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Cervical Preparation Before Dilation and Evacuation in the Second Trimester: A Multicenter Randomized Trial Comparing Osmotic Dilators Alone to Dilators Plus Adjunctive Misoprostol or Adjunctive Mifepristone.
The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion.
- Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix
- Osmotic dilators plus mifepristone, a medicine that is swallowed
- Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum
Read more
Hypotheses:
- adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer.
- adding oral mifepristone at the time of laminaria placement will confer a similar benefit.
- the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents.
- significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences.
- patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.
- Conditions
- Abortion, Induced
- Being tested
- Mifepristone, misoprostol, Osmotic dilators, placebo
- Keywords
- abortion, induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneOther
Also called Mifeprex
oral mifepristone 200 mg on Day 1.
misoprostolDrug
Also called Cytotec
buccal misoprostol 400 mcg on Day 2
Osmotic dilatorsDevice
Also called laminaria, Dilapan-S
osmotic dilators on Day 1
placeboOther
Also called vitamin C 500 mg
placebo for mifepristone, on day 1
placeboOther
Also called vitamin B12 500 mcg
placebo for misoprostol, on day 2
| Study group | Role | What they receive |
|---|---|---|
| Osmotic dilators + placebo (vit c) + placebo (vit B12) | Other | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Receives: Device: Osmotic dilators; Other: placebo |
| Osmotic dilators + placebo (vit c) + misoprostol | Active comparator | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. Receives: Drug: misoprostol; Device: Osmotic dilators; Other: placebo |
| Osmotic dilators + mifepristone + placebo (vit B12) | Active comparator | Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Receives: Other: Mifepristone; Device: Osmotic dilators; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
The duration of the D\&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D\&E
Measured: participants were assessed for the duration of the procedure, an average of 6 minutes
Secondary outcomes (8)
Initial Cervical Dilation
Measured at the time of procedure (immediately before the start of D\&E)
Measured: participants were assessed during cervical dilation process, average time of 1 minute
Ability to Complete the D&E on the First Attempt
Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.
Measured: participants were assessed for the duration of the procedure, an average of 6 minutes
Need for Mechanical Dilation
Assessed on Day of procedure. Assessed immediately after completion of D\&E
Measured: participants were assessed for the duration of the procedure, an average of 6 minutes
Ease of Mechanical Dilation
Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D\&E
Measured: participants were assessed for the duration of the procedure, an average of 6 minutes
Complications From Procedure
Patient having any complication, including hospitalizations transfusions additional unplanned procedures
Measured: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
Chills (Any) After Day 2 Medication Administration
chills (any) after Day 2 medication administration
Measured: assessed immediately after administration of day 2 medication
Patient Satisfaction With Cervical Prep
Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D\&E procedure and just prior to discharge home.
Measured: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
Physician Satisfaction With Cervical Preparation
Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D\&E procedure.
Measured: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionJun 2014
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, MD, MPH, Principal investigator, Planned Parenthood League of Massachusetts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751087
- Sponsor's protocol ID
- 9-500-25.1
- Other IDs
- SFPRF6-MS
- Status last verified
- Jan 2016
- First submitted
- 12 Dec 2012
- Last updated
- 24 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Goldberg AB, Fortin JA, Drey EA, Dean G, Lichtenberg ES, Bednarek PH, Chen BA, Dutton C, McKetta S, Maurer R, Winikoff B, Fitzmaurice GM. Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):599-609. doi: 10.1097/AOG.0000000000000977.
PubMed 26196084
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Preparation Before Dilation and Evacuation in the Second Trimester: A Multicenter Randomized Trial Comparing Osmotic Dilators Alone to Dilators Plus Adjunctive Misoprostol or Adjunctive Mifepristone.
- ClinicalTrials.gov ID
- NCT01751087
- Acronym / sponsor ID
- 9-500-25.1
- Conditions
- Abortion, Induced
- Keywords
- abortion, induced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 24 Feb 2016
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 research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion.
- Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix
- Osmotic dilators plus mifepristone, a medicine that is swallowed
- Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum
Hypotheses:
- adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer.
- adding oral mifepristone at the time of laminaria placement will confer a similar benefit.
- the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents.
- significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences.
- patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osmotic dilators + placebo (vit c) + placebo (vit B12) | Other | Device: Osmotic dilators, Other: placeboWomen will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. |
| Osmotic dilators + placebo (vit c) + misoprostol | Active comparator | Drug: misoprostol, Device: Osmotic dilators, Other: placeboWomen will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. |
| Osmotic dilators + mifepristone + placebo (vit B12) | Active comparator | Other: Mifepristone, Device: Osmotic dilators, Other: placeboWomen will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Able to give informed consent
- Medically eligible for outpatient second trimester pregnancy termination at the clinical site
- English-speaking or Spanish-speaking at sites with ability to obtain informed consent in Spanish
Key exclusion criteria (9 listed)
- Active bleeding (>1 pad/hour) or hemodynamically unstable at enrollment
- Signs of chorioamnionitis or clinical infection at enrollment
- Signs of spontaneous labor or cervical insufficiency at enrollment
- Spontaneous intrauterine fetal demise
- Patient incarcerated
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 |
|---|---|---|
| MifepristoneAlso: Mifeprexoral mifepristone 200 mg on Day 1. | Other | Osmotic dilators + mifepristone + placebo (vit B12) |
| misoprostolAlso: Cytotecbuccal misoprostol 400 mcg on Day 2 | Drug | Osmotic dilators + placebo (vit c) + misoprostol |
| Osmotic dilatorsAlso: laminaria, Dilapan-Sosmotic dilators on Day 1 | Device | Osmotic dilators + mifepristone + placebo (vit B12), Osmotic dilators + placebo (vit c) + misoprostol, Osmotic dilators + placebo (vit c) + placebo (vit B12) |
| placeboAlso: vitamin C 500 mgplacebo for mifepristone, on day 1 | Other | Osmotic dilators + placebo (vit c) + misoprostol, Osmotic dilators + placebo (vit c) + placebo (vit B12) |
| placeboAlso: vitamin B12 500 mcgplacebo for misoprostol, on day 2 | Other | Osmotic dilators + mifepristone + placebo (vit B12), Osmotic dilators + placebo (vit c) + placebo (vit B12) |
Primary outcome
Operative Time
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
The duration of the D\&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D\&E
8 secondary outcomes
Initial Cervical Dilation
Time frame: participants were assessed during cervical dilation process, average time of 1 minute
Ability to Complete the D&E on the First Attempt
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Need for Mechanical Dilation
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Ease of Mechanical Dilation
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Complications From Procedure
Time frame: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
Chills (Any) After Day 2 Medication Administration
Time frame: assessed immediately after administration of day 2 medication
Patient Satisfaction With Cervical Prep
Time frame: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
Physician Satisfaction With Cervical Preparation
Time frame: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26196084Goldberg AB, Fortin JA, Drey EA, Dean G, Lichtenberg ES, Bednarek PH, Chen BA, Dutton C, McKetta S, Maurer R, Winikoff B, Fitzmaurice GM. Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):599-609. doi: 10.1097/AOG.0000000000000977.
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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.
Principal Investigator, MD, MPH principal investigator
Planned Parenthood League of Massachusetts
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifepristone, misoprostol and Osmotic dilators in people with Abortion, Induced, run by Planned Parenthood League of Massachusetts at 7 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 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 24 Feb 2016). 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?
Operative Time (time frame: participants were assessed for the duration of the procedure, an average of 6 minutes). 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 NCT01751087, 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 24 Feb 2016.