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Cervical Priming Before Dilation & Evacuation

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ClinicalTrials.gov Identifier: NCT01597726
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : November 7, 2013
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

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Abortion, Induced Drug: Misoprostol Device: Laminaria Not Applicable

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial
Study Start Date : May 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Misoprostol 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
Experimental: Laminaria Device: Laminaria
Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E



Primary Outcome Measures :
  1. Proportion of women with fetal expulsion prior to dilation and evacuation [ Time Frame: Prior to D&E procedure ]

Secondary Outcome Measures :
  1. Proportion of women requiring additional dilation (manual or pharmacologic) [ Time Frame: At time of D&E procedure ]
  2. Duration of dilation and evacuation procedure [ Time Frame: End of D&E procedure ]
  3. Frequency of major complications [ Time Frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) ]

    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

  4. Frequency of Minor Complications [ Time Frame: Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) ]

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597726


Locations
South Africa
Tygerberg Hospital
Cape Town, South Africa, 7505
Sponsors and Collaborators
Ibis Reproductive Health
University of Cape Town
Tygerberg Hospital
Safe Abortion Action Fund of the International Planned Parenthood Federation
Society of Family Planning
Investigators
Principal Investigator: Judy Kluge, MBChB Tygerberg Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ibis Reproductive Health
ClinicalTrials.gov Identifier: NCT01597726     History of Changes
Other Study ID Numbers: 32020
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013

Keywords provided by Ibis Reproductive Health:
Abortion, Induced
Laminaria
Misoprostol
Pregnancy Trimester, Second

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics