Cervical Priming Before Dilation & Evacuation

Study Overview
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Brief Summary
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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

Detailed Description
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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: 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) Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E

Official Title
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Cervical Priming Before Dilation & Evacuation: a Randomized Controlled Trial

Conditions
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Abortion, Induced

Intervention / Treatment
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* Drug: Misoprostol
* Device: Laminaria


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol<br> | Drug: Misoprostol<br>* Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D&E, repeated once 3 hours after the first dose if needed<br>|
| Experimental: Laminaria<br> | Device: Laminaria<br>* Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women with fetal expulsion prior to dilation and evacuation |  | Prior to D&E procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women requiring additional dilation (manual or pharmacologic) |  | At time of D&E procedure | 
| Duration of dilation and evacuation procedure |  | End of D&E procedure | 
| Frequency of major complications | 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 | Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) | 
| Frequency of Minor Complications | 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 | Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abortion, Induced, Laminaria, Misoprostol, Pregnancy Trimester, Second