Misoprostol Versus Dilapan-S for Cervical Preparation
This study has been completed.
Sponsor:
Planned Parenthood League of Massachusetts
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT00835731
First received: February 3, 2009
Last updated: May 8, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cervical Ripening |
Drug: misoprostol Device: Dilapan-S, vitamin B-12 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Planned Parenthood League of Massachusetts:
Primary Outcome Measures:
- cervical dilation in women following exposure to either ripening agent [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- ease of further mechanical dilation [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]
- procedure time for dilation and evacuation [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]
- ability of physician to complete dilation and evacuation procedure on first attempt [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]
- subject pain during ripening [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]
- subject pain during dilation and evacuation [ Time Frame: 3-4 hours after placement of ripening agent ] [ Designated as safety issue: No ]
- women's preferences for cervical ripening method [ Time Frame: 5 hours after placement of ripening agent ] [ Designated as safety issue: No ]
| Enrollment: | 125 |
| Study Start Date: | January 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
400mcg buccal misoprostol
|
Drug: misoprostol
400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E
Other Name: Cytotec
|
|
Experimental: 2
Dilapan-S, control: vitamin B-12 administered sublingually
|
Device: Dilapan-S, vitamin B-12
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835731
Locations
| United States, Massachusetts | |
| Planned Parenthood League of Massachusetts | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Society of Family Planning
Investigators
| Principal Investigator: | Prinicpal Investigator | Planned Parenthood League of Massachusetts |
More Information
No publications provided
| Responsible Party: | Planned Parenthood League of Massachusetts |
| ClinicalTrials.gov Identifier: | NCT00835731 History of Changes |
| Other Study ID Numbers: | SFP2-3 |
| Study First Received: | February 3, 2009 |
| Last Updated: | May 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Planned Parenthood League of Massachusetts:
|
induced abortion misoprostol cervical ripening second trimester abortion Dilapan-S |
Additional relevant MeSH terms:
|
Vitamin B 12 Hydroxocobalamin Vitamin B Complex Vitamins Misoprostol Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
Hematinics Hematologic Agents Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Reproductive Control Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 23, 2013