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Clinical Trial Summary

The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion.

- Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix

- Osmotic dilators plus mifepristone, a medicine that is swallowed

- Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum

Hypotheses:

- adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer.

- adding oral mifepristone at the time of laminaria placement will confer a similar benefit.

- the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents.

- significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences.

- patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01751087
Study type Interventional
Source Planned Parenthood League of Massachusetts
Contact
Status Completed
Phase N/A
Start date January 2013
Completion date June 2014

See also
  Status Clinical Trial Phase
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Completed NCT02277249 - Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion N/A
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Completed NCT01597726 - Cervical Priming Before Dilation & Evacuation N/A
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Completed NCT00382538 - Mifepristone and Mid-Trimester Termination of Pregnancy N/A
Completed NCT03080493 - Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial Phase 4
Completed NCT02485444 - Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion Phase 4
Completed NCT00969982 - Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP)) N/A
Recruiting NCT02480543 - Different Routes of Misoprostol Prior to First Trimester Surgical Abortion Phase 4
Completed NCT00870272 - Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP) N/A
Completed NCT02048098 - Misoprostol for Second Trimester Termination of Pregnancy Phase 3