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N/A N=300 Randomized Triple-blind Treatment

Cervical Preparation Before Dilation and Evacuation

Abortion, Induced

Enrolled (actual)
300
Serious AEs
1.3%
Results posted
Feb 2016
Primary outcome: Primary: Operative Time — 6.27; 6.28; 5.53 minutes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Mifepristone (Other); misoprostol (Drug); Osmotic dilators (Device); placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Planned Parenthood League of Massachusetts
Primary completion
Feb 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Operative Time
6.27; 6.28; 5.53
SECONDARY
Initial Cervical Dilation
2.2; 2.5; 2.4
SECONDARY
Ability to Complete the D&E on the First Attempt
98; 98; 98
SECONDARY
Need for Mechanical Dilation
26; 9; 16
SECONDARY
Ease of Mechanical Dilation
6; 4; 1
SECONDARY
Complications From Procedure
10; 2; 2
SECONDARY
Chills (Any) After Day 2 Medication Administration
12; 39; 18
SECONDARY
Patient Satisfaction With Cervical Prep
72; 80; 80
SECONDARY
Physician Satisfaction With Cervical Preparation
71; 78; 85

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.

Eligibility Criteria

Inclusion Criteria

  • 18 years and older
  • Able to give informed consent
  • Medically eligible for outpatient second trimester pregnancy termination at the clinical site
  • English-speaking or Spanish-speaking at sites with ability to obtain informed consent in Spanish

Exclusion Criteria

  • Active bleeding (>1 pad/hour) 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
  • Patient incarcerated
  • Allergy to mifepristone or misoprostol
  • Chronic steroid use or adrenal insufficiency
  • Porphyria
  • Inflammatory bowel disease requiring treatment
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01751087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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