Cervical Priming Before Dilation & Evacuation

• Proportion of women with fetal expulsion prior to dilation and evacuation [ Time Frame: Prior to D&E procedure ] [ Designated as safety issue: Yes ]
  

• Proportion of women requiring additional dilation (manual or pharmacologic) [ Time Frame: At time of D&E procedure ] [ Designated as safety issue: No ]
  
• Duration of dilation and evacuation procedure [ Time Frame: End of D&E procedure ] [ Designated as safety issue: No ]
  
• Frequency of major complications [ Time Frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) ] [ Designated as safety issue: Yes ]

  Major complications to include:

  • Death
  • Admission to the ward after the procedure
  • Readmission after discharge
  • Abdominal surgical procedure
  • Suspected uterine perforation
  • Seizure
  • Hemorrhage requiring transfusion
  • Loss to follow-up after placement of laminaria
  
  
• Frequency of Minor Complications [ Time Frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) ] [ Designated as safety issue: Yes ]

  Minor complications to include:

  • Hemorrhage not requiring transfusion
  • Infection requiring outpatient treatment
  • Trauma to cervix or vagina
  • Transfer to another facility to complete the procedure
  • Need for repeat surgical evacuation of the uterus
  
  

As misoprostol is increasingly being used for cervical preparation, concerns about its use and about the proportion of women expelling the fetus prior to the D&E and other side effects mean that rigorous data on possible advantages of osmotic dilators are needed. To address this gap in the literature, we propose to perform an RCT comparing two methods of cervical preparation prior to D&E:

1. Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D&E, repeated once 3 hours after the first dose (a modified version of the current protocol)
2. Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E