Cervical Priming Before Dilation & Evacuation

This study has been completed.
Sponsor:
Collaborators:
University of Cape Town
Tygerberg Hospital
Safe Abortion Action Fund of the International Planned Parenthood Federation
Society of Family Planning
Information provided by (Responsible Party):
Ibis Reproductive Health
ClinicalTrials.gov Identifier:
NCT01597726
First received: May 10, 2012
Last updated: November 6, 2013
Last verified: November 2013

May 10, 2012
November 6, 2013
May 2012
June 2013   (final data collection date for primary outcome measure)
Proportion of women with fetal expulsion prior to dilation and evacuation [ Time Frame: Prior to D&E procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01597726 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Cervical Priming Before Dilation & Evacuation
Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial

The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming to laminaria priming among women undergoing D&E at 13-20 weeks gestation in the Western Cape Province, South Africa

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Abortion, Induced
  • Drug: Misoprostol
    Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D&E, repeated once 3 hours after the first dose if needed
  • Device: Laminaria
    Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E
  • Active Comparator: Misoprostol
    Intervention: Drug: Misoprostol
  • Experimental: Laminaria
    Intervention: Device: Laminaria
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Woman seeking TOP between 13 and 20 weeks gestation as determined by ultrasound
  • Age 18 or greater
  • Willingness to participate in randomized study
  • Fluency in English, Afrikaans or Xhosa
  • Ability to give informed consent
  • Staying within one hour travel time of Tygerberg Hospital for the night prior to the D&E
  • Ability to be contacted by telephone

Exclusion Criteria:

  • Active cervicitis
  • Multiple gestation
  • Fetal demise confirmed by ultrasound examination
  • History of bleeding disorder or current anticoagulation therapy
  • Allergy to misoprostol
  • Currently breastfeeding and unwilling or unable to temporarily discard milk
  • More than one prior cesarean delivery
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01597726
32020
No
Ibis Reproductive Health
Ibis Reproductive Health
  • University of Cape Town
  • Tygerberg Hospital
  • Safe Abortion Action Fund of the International Planned Parenthood Federation
  • Society of Family Planning
Principal Investigator: Judy Kluge, MBChB Tygerberg Hospital
Ibis Reproductive Health
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP