Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
72 participants
INTERVENTIONAL
2008-10-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
laminaria
laminaria placed for cervical dilation; usual standard of care in study clinic
laminaria
place device in cervix for dilation
Dilapan-S
experimental treatment
Dilapan-S
Place in cervix for dilation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laminaria
place device in cervix for dilation
Dilapan-S
Place in cervix for dilation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Request for elective abortion and certainty of decision to proceed
Exclusion Criteria
* Minor status (women younger than eighteen years)
* Allergy to Dilapan or laminaria
* Inability to speak and understand Spanish or English
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eleanor Drey, MD
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Francisco General Hospital
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1176030877
Identifier Type: -
Identifier Source: org_study_id