Cervical RipeningNCT00835731
Misoprostol Versus Dilapan-S for Cervical Preparation
A study testing misoprostol and Dilapan-S, vitamin B-12 in people with Cervical Ripening, run by Planned Parenthood League of Massachusetts at 1 site in United States.
Trial summary
The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation. 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
- Cervical Ripening
- What is being tested?
- misoprostol and Dilapan-S, vitamin B-12
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2011
- 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
- medically eligible for dilation and evacuation at Planned Parenthood League of Massachusetts
- gestational age 12 weeks 0 days to 15 weeks 0 days as evaluated by ultrasound
- proficient in English or Spanish
- agreeing to study procedures, including randomization and surveys regarding demographics, medical and gynecological history, and assessments of pain and satisfaction
Who cannot join
- less than 18 years old
- cervical or uterine anomaly that the research physician deems may affect the difficulty of dilation or the abortion procedure
- inflammatory bowel disease
- contraindication to misoprostol use
- known intolerance or allergy to misoprostol or Dilapan-S
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
About this study
Official title: Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial
The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.
- Conditions
- Cervical Ripening
- Being tested
- misoprostol, Dilapan-S, vitamin B-12
- Keywords
- induced abortion, misoprostol, cervical ripening, second trimester abortion, Dilapan-S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
Also called Cytotec
400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E
Dilapan-S, vitamin B-12Device
One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 400mcg buccal misoprostol Receives: Drug: misoprostol |
| 2 | Experimental | Dilapan-S, control: vitamin B-12 administered sublingually Receives: Device: Dilapan-S, vitamin B-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Dilation in Women Following Exposure to Either Ripening Agent
Measured: 3-4 hours after placement of ripening agent
Secondary outcomes (6)
Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report
Scale:
None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5)
Measured: 3-4 hours after placement of ripening agent
Procedure Time for Dilation and Evacuation
Measured: 3-4 hours after placement of ripening agent
Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt
Measured: 3-4 hours after placement of ripening agent
Subject Pain During Ripening
Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D\&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:
0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain
Higher values represent a worse outcome.
Measured: 3-4 hours after placement of ripening agent
Subject Pain During Dilation and Evacuation
Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D\&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:
0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain
Higher values represent a worse outcome.
Measured: 3-4 hours after placement of ripening agent
Women's Satisfaction With Cervical Ripening Method
Scale:
1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied
Measured: 5 hours after placement of ripening agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
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 (2)Papers the sponsor has linked to this study.
- Other trials for Cervical RipeningStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 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
- Prinicpal Investigator, Principal investigator, Planned Parenthood League of Massachusetts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835731
- Sponsor's protocol ID
- SFP2-3
- Status last verified
- Sep 2017
- First submitted
- 3 Feb 2009
- Last updated
- 23 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PubMed 34061352Bartz D, Maurer R, Allen RH, Fortin J, Kuang B, Goldberg AB. Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889.
PubMed 23743471
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00835731
- Acronym / sponsor ID
- SFP2-3
- Conditions
- Cervical Ripening
- Keywords
- induced abortion, misoprostol, cervical ripening, second trimester abortion, Dilapan-S
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 7 Jan 2014
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 compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: misoprostol400mcg buccal misoprostol |
| 2 | Experimental | Device: Dilapan-S, vitamin B-12Dilapan-S, control: vitamin B-12 administered sublingually |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- medically eligible for dilation and evacuation at Planned Parenthood League of Massachusetts
- gestational age 12 weeks 0 days to 15 weeks 0 days as evaluated by ultrasound
- proficient in English or Spanish
- agreeing to study procedures, including randomization and surveys regarding demographics, medical and gynecological history, and assessments of pain and satisfaction
Key exclusion criteria (6 listed)
- less than 18 years old
- cervical or uterine anomaly that the research physician deems may affect the difficulty of dilation or the abortion procedure
- inflammatory bowel disease
- contraindication to misoprostol use
- known intolerance or allergy to misoprostol or Dilapan-S
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 |
|---|---|---|
| misoprostolAlso: Cytotec400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E | Drug | 1 |
| Dilapan-S, vitamin B-12One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D\&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D\&E | Device | 2 |
Primary outcome
Cervical Dilation in Women Following Exposure to Either Ripening Agent
Time frame: 3-4 hours after placement of ripening agent
6 secondary outcomes
Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report
Time frame: 3-4 hours after placement of ripening agent
Procedure Time for Dilation and Evacuation
Time frame: 3-4 hours after placement of ripening agent
Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt
Time frame: 3-4 hours after placement of ripening agent
Subject Pain During Ripening
Time frame: 3-4 hours after placement of ripening agent
Subject Pain During Dilation and Evacuation
Time frame: 3-4 hours after placement of ripening agent
Women's Satisfaction With Cervical Ripening Method
Time frame: 5 hours after placement of ripening agent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34061352Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
- Derived from this study: PubMed 23743471Bartz D, Maurer R, Allen RH, Fortin J, Kuang B, Goldberg AB. Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889.
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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.
Prinicpal Investigator principal investigator
Planned Parenthood League of Massachusetts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing misoprostol and Dilapan-S, vitamin B-12 in people with Cervical Ripening, run by Planned Parenthood League of Massachusetts 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 4 inclusion and 6 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 23 Oct 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2014). 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?
Cervical Dilation in Women Following Exposure to Either Ripening Agent (time frame: 3-4 hours after placement of ripening agent). 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 NCT00835731, 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 23 Oct 2017.