Cervical PreparationDvLNCT00775983

Dilapan Versus Laminaria

A study testing laminaria and Dilapan-S in people with Cervical Preparation, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Preparation
What is being tested?: laminaria and Dilapan-S
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: Oct 2008to Dec 2009
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

Pregnancy between fourteen and eighteen weeks gestation
Request for elective abortion and certainty of decision to proceed

Who cannot join

Incarceration
Minor status (women younger than eighteen years)
Allergy to Dilapan or laminaria
Inability to speak and understand Spanish or English

Trial locations and contacts

1 site in 1 country.

United States1 site

San Francisco General Hospital
San Francisco, California, 94110

Other trials in United States

About this study

Official title: Same-day Dilapan Versus Overnight Laminaria for Cervical Preparation for Early Second-trimester Surgical Abortion

This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day Dilapan for cervical preparation for surgical abortions occurring between fourteen and eighteen weeks gestation. Comparisons will be made between procedure time, need for additional dilation, occurrence of complications, and patient and provider satisfaction.

Hypothesis:

Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation, with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within a five-minute difference.

Primary objective:

Determine differences in procedure times

Secondary objectives:

Examine complications, and need for additional dilation between early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria

Conditions: Cervical Preparation
Being tested: laminaria, Dilapan-S

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

laminariaDevice
place device in cervix for dilation
Dilapan-SDevice
Place in cervix for dilation.

Study groups in NCT00775983
Study group	Role	What they receive
laminaria	Active comparator	laminaria placed for cervical dilation; usual standard of care in study clinic Receives: Device: laminaria
Dilapan-S	Experimental	experimental treatment Receives: Device: Dilapan-S

What is being measured

The primary outcome is the main question the study is designed to answer.

Procedure Time
Procedure time to complete early second-trimester dilation and evacuation (D\&E)
Measured: Day of procedure

Secondary outcomes (1)

Participants Who Experienced Complications or Need for Additional Dilation
Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria
Measured: Day of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Dec 2009

First posted20 Oct 2008 (estimated)
Study startOct 2008
Primary completionDec 2009
Study completionDec 2009

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 Cervical PreparationStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00775983
Sponsor's protocol ID: 1176030877
Acronym: DvL
Status last verified: Oct 2013
First submitted: 16 Oct 2008
Last updated: 14 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Newmann SJ, Sokoloff A, Tharyil M, Illangasekare T, Steinauer JE, Drey EA. Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):271-278. doi: 10.1097/AOG.0000000000000080.
PubMed 24402587

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Same-day Dilapan Versus Overnight Laminaria for Cervical Preparation for Early Second-trimester Surgical Abortion
ClinicalTrials.gov ID: NCT00775983
Acronym / sponsor ID: DvL / 1176030877
Conditions: Cervical Preparation
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: Oct 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 20 Oct 2008 (estimated)
Results: Posted 17 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypothesis:

Primary objective:

Determine differences in procedure times

Secondary objectives:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
laminaria	Active comparator	Device: laminarialaminaria placed for cervical dilation; usual standard of care in study clinic
Dilapan-S	Experimental	Device: Dilapan-Sexperimental treatment

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Pregnancy between fourteen and eighteen weeks gestation
Request for elective abortion and certainty of decision to proceed

Key exclusion criteria (4 listed)

Incarceration
Minor status (women younger than eighteen years)
Allergy to Dilapan or laminaria
Inability to speak and understand Spanish or English

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
laminariaplace device in cervix for dilation	Device	laminaria
Dilapan-SPlace in cervix for dilation.	Device	Dilapan-S

Primary outcome

Procedure Time
Time frame: Day of procedure
Procedure time to complete early second-trimester dilation and evacuation (D\&E)

1 secondary outcome

Participants Who Experienced Complications or Need for Additional Dilation
Time frame: Day of procedure

Results and safety

Results posted to the registry on 17 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Laminaria	36	35
Dilapan-S	36	34

Primary outcome: Procedure Time

Time frame: Day of procedure. Mean (Standard Error). Unit: minutes

Measure	Overnight Laminaria n = 35	Dilapan-S n = 34
Value	5.9 (2.9)	8.1 (5.5)

Overnight Laminaria vs Dilapan-S: Mean Difference (Final Values): 2.1 (97.5% CI -0.3 to 4.5), t-test, 2 sided

Population analysed: All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day of procedure and one-week follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laminaria	0 of 35 (0%)	0 of 35 (0%)	Not reported
Dilapan-S	0 of 34 (0%)	0 of 34 (0%)	Not reported

Limitations and caveats (from the sponsor): -inadequate power to compare complications directly between study groups. Procedure time was chosen as a proxy for procedural difficulty and thus potential complications

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24402587Newmann SJ, Sokoloff A, Tharyil M, Illangasekare T, Steinauer JE, Drey EA. Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):271-278. doi: 10.1097/AOG.0000000000000080.

Related trials for Cervical Preparation

Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Recruiting
Cervical Ripening Balloons for Same-Day Cervical Prep
Dilation and Evacuation
Active, not recruitingPhase 1
To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer
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RecruitingPhase 1
Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing laminaria and Dilapan-S in people with Cervical Preparation, run by University of California, San Francisco 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 2 inclusion and 4 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 Nov 2013. 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 17 Jul 2013). 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: Day of procedure). 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 NCT00775983, 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 14 Nov 2013.