Cervical Dilation Prior to Dilation and EvacuationNCT03002441
Same-day Cervical Preparation Before Dilation and Evacuation
A study testing Same-Day Dilapan-S and Overnight Dilapan-S in people with Cervical Dilation Prior to Dilation and Evacuation, run by Planned Parenthood of Greater New York at 1 site in United States.
Trial summary
The purpose of this randomized trial is to compare same-day cervical preparation using Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before D\&E at 16.0 to 20.0 weeks. Primary objective: To compare D\&E operative time. 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 Dilation Prior to Dilation and Evacuation
- What is being tested?
- Same-Day Dilapan-S and Overnight Dilapan-S
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 28 Feb 2020
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Seeking pregnancy termination from 16 0/7 to 19 6/7 weeks of gestation on the day of enrollment.
- Eligible for pregnancy termination at PPNYC
- Able to give informed consent
- English speaking
Who cannot join
- Active bleeding 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
- Allergy to Dilapan-S™ or misoprostol
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood of Greater New York
New York, New York, 10012
About this study
Official title: Same-day Cervical Preparation With Dilapan-S™ Plus Buccal Misoprostol Compared to Overnight Dilapan-S™ Before Dilation and Evacuation at 16 to 20 Weeks' Gestation: A Randomized Controlled Trial
The purpose of this randomized trial is to compare same-day cervical preparation using Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before D\&E at 16.0 to 20.0 weeks.
Primary objective: To compare D\&E operative time. We hypothesize that same-day Dilapan-S™ plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative time.
Secondary objectives: To compare treatment groups for the following: Pre-operative cervical dilation; need for mechanical dilation and ease of dilation if required; ability to complete D\&E without further cervical preparation; ease of D\&E; complications; pain; side effects; patient and provider satisfaction.
- Being tested
- Same-Day Dilapan-S, Overnight Dilapan-S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-Day Dilapan-SDevice
Dilapan-S cervical dilators placed the same day as the D\&E procedure
Overnight Dilapan-SDevice
Dilapan-S cervical dilators placed the day prior to D\&E procedure
| Study group | Role | What they receive |
|---|---|---|
| Same-day Dilators | Active comparator | Participants will have Dilapan-S cervical dilators placed 4-6 hours prior to D\&E and will receive 400 mcg buccal misoprostol pills 3 hours prior to D\&E. Receives: Device: Same-Day Dilapan-S |
| Overnight dilators | Active comparator | Participants will have Dilapan-S cervical dilators placed the day prior to their D\&E procedure and will receive buccal placebo pills (vitamin B12) 3 hours prior to D\&E. Receives: Device: Overnight Dilapan-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Measured: From initiation of D&E procedure to completion of D&E procedure, Study Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Dilation Prior to Dilation and EvacuationStudies 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, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood of Greater New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ila Dayananda, Principal investigator, Planned Parenthood of Greater New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002441
- Sponsor's protocol ID
- Same Day CPrep
- Status last verified
- Apr 2021
- First submitted
- 6 Dec 2016
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim CS, Dragoman M, Porsch L, Markowitz J, Lunde B, Stoffels G, Dayananda I. Same-Day Compared With Overnight Cervical Preparation Before Dilation and Evacuation Between 16 and 19 6/7 Weeks of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1141-1144. doi: 10.1097/AOG.0000000000004790. Epub 2022 May 2.
PubMed 35675611
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same-day Cervical Preparation With Dilapan-S™ Plus Buccal Misoprostol Compared to Overnight Dilapan-S™ Before Dilation and Evacuation at 16 to 20 Weeks' Gestation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03002441
- Acronym / sponsor ID
- Same Day CPrep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Planned Parenthood of Greater New YorkUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 23 Dec 2016 (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 randomized trial is to compare same-day cervical preparation using Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before D\&E at 16.0 to 20.0 weeks.
Primary objective: To compare D\&E operative time. We hypothesize that same-day Dilapan-S™ plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative time.
Secondary objectives: To compare treatment groups for the following: Pre-operative cervical dilation; need for mechanical dilation and ease of dilation if required; ability to complete D\&E without further cervical preparation; ease of D\&E; complications; pain; side effects; patient and provider satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same-day Dilators | Active comparator | Device: Same-Day Dilapan-SParticipants will have Dilapan-S cervical dilators placed 4-6 hours prior to D\&E and will receive 400 mcg buccal misoprostol pills 3 hours prior to D\&E. |
| Overnight dilators | Active comparator | Device: Overnight Dilapan-SParticipants will have Dilapan-S cervical dilators placed the day prior to their D\&E procedure and will receive buccal placebo pills (vitamin B12) 3 hours prior to D\&E. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and older
- Seeking pregnancy termination from 16 0/7 to 19 6/7 weeks of gestation on the day of enrollment.
- Eligible for pregnancy termination at PPNYC
- Able to give informed consent
- English speaking
Key exclusion criteria (5 listed)
- Active bleeding 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
- Allergy to Dilapan-S™ or 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 |
|---|---|---|
| Same-Day Dilapan-SDilapan-S cervical dilators placed the same day as the D\&E procedure | Device | Same-day Dilators |
| Overnight Dilapan-SDilapan-S cervical dilators placed the day prior to D\&E procedure | Device | Overnight dilators |
Primary outcome
Operative time
Time frame: From initiation of D&E procedure to completion of D&E procedure, Study Day 2
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 22 Apr 2021.
- Derived from this study: PubMed 35675611Kim CS, Dragoman M, Porsch L, Markowitz J, Lunde B, Stoffels G, Dayananda I. Same-Day Compared With Overnight Cervical Preparation Before Dilation and Evacuation Between 16 and 19 6/7 Weeks of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1141-1144. doi: 10.1097/AOG.0000000000004790. Epub 2022 May 2.
- Individual participant dataSharing planned: No
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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.
Ila Dayananda principal investigator
Planned Parenthood of Greater New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same-Day Dilapan-S and Overnight Dilapan-S in people with Cervical Dilation Prior to Dilation and Evacuation, run by Planned Parenthood of Greater New York 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 5 inclusion and 5 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 22 Apr 2021. 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?
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?
Operative time (time frame: From initiation of D&E procedure to completion of D&E procedure, Study Day 2). 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 NCT03002441, 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 22 Apr 2021.