Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
159 participants
INTERVENTIONAL
2012-05-31
2013-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Misoprostol
Misoprostol
Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose if needed
Laminaria
Laminaria
Laminaria tents inserted into the cervix 18 to 24 hours prior to D\&E
Interventions
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Misoprostol
Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D\&E, repeated once 3 hours after the first dose if needed
Laminaria
Laminaria tents inserted into the cervix 18 to 24 hours prior to D\&E
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University of Cape Town
OTHER
Tygerberg Hospital
UNKNOWN
Safe Abortion Action Fund of the International Planned Parenthood Federation
UNKNOWN
Society of Family Planning
OTHER
Ibis Reproductive Health
OTHER
Responsible Party
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Principal Investigators
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Judy Kluge, MBChB
Role: PRINCIPAL_INVESTIGATOR
Tygerberg Hospital
Locations
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Tygerberg Hospital
Cape Town, , South Africa
Countries
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References
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Constant D, Kluge J, Harries J, Grossman D. An analysis of delays among women accessing second-trimester abortion in the public sector in South Africa. Contraception. 2019 Sep;100(3):209-213. doi: 10.1016/j.contraception.2019.04.009. Epub 2019 Apr 25.
Grossman D, Constant D, Lince-Deroche N, Harries J, Kluge J. A randomized trial of misoprostol versus laminaria before dilation and evacuation in South Africa. Contraception. 2014 Sep;90(3):234-41. doi: 10.1016/j.contraception.2014.05.003. Epub 2014 May 14.
Related Links
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Click here to visit the Ibis Reproductive Health website
Other Identifiers
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32020
Identifier Type: -
Identifier Source: org_study_id