Cervical Preparation Before Dilation and Evacuation

Study Overview
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Brief Summary
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The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion. Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix Osmotic dilators plus mifepristone, a medicine that is swallowed Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum Hypotheses: adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer. adding oral mifepristone at the time of laminaria placement will confer a similar benefit. the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents. significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences. patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.

Official Title
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Cervical Preparation Before Dilation and Evacuation in the Second Trimester: A Multicenter Randomized Trial Comparing Osmotic Dilators Alone to Dilators Plus Adjunctive Misoprostol or Adjunctive Mifepristone.

Conditions
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Abortion, Induced

Intervention / Treatment
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* Other: Mifepristone
* Drug: misoprostol
* Device: Osmotic dilators
* Other: placebo
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Able to give informed consent Medically eligible for outpatient second trimester pregnancy termination at the clinical site English-speaking or Spanish-speaking at sites with ability to obtain informed consent in Spanish Exclusion Criteria: Active bleeding (>1 pad/hour) or hemodynamically unstable at enrollment Signs of chorioamnionitis or clinical infection at enrollment Signs of spontaneous labor or cervical insufficiency at enrollment Spontaneous intrauterine fetal demise Patient incarcerated Allergy to mifepristone or misoprostol Chronic steroid use or adrenal insufficiency Porphyria Inflammatory bowel disease requiring treatment

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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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Osmotic dilators + placebo (vit c) + placebo (vit B12)<br>Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. | Device: Osmotic dilators<br>* osmotic dilators on Day 1<br>* Other names: Dilapan-S;Other: placebo<br>* placebo for mifepristone, on day 1<br>* Other names: vitamin C 500 mg;Other: placebo<br>* placebo for misoprostol, on day 2<br>* Other names: vitamin B12 500 mcg;|
| Active Comparator: Osmotic dilators + placebo (vit c) + misoprostol<br>Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. | Drug: misoprostol<br>* buccal misoprostol 400 mcg on Day 2<br>* Other names: Cytotec;Device: Osmotic dilators<br>* osmotic dilators on Day 1<br>* Other names: Dilapan-S;Other: placebo<br>* placebo for mifepristone, on day 1<br>* Other names: vitamin C 500 mg;|
| Active Comparator: Osmotic dilators + mifepristone + placebo (vit B12)<br>Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. | Other: Mifepristone<br>* oral mifepristone 200 mg on Day 1.<br>* Other names: Mifeprex;Device: Osmotic dilators<br>* osmotic dilators on Day 1<br>* Other names: Dilapan-S;Other: placebo<br>* placebo for misoprostol, on day 2<br>* Other names: vitamin B12 500 mcg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E | participants were assessed for the duration of the procedure, an average of 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial Cervical Dilation | Measured at the time of procedure (immediately before the start of D&E) | participants were assessed during cervical dilation process, average time of 1 minute | 
| Ability to Complete the D&E on the First Attempt | Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day. | participants were assessed for the duration of the procedure, an average of 6 minutes | 
| Need for Mechanical Dilation | Assessed on Day of procedure. Assessed immediately after completion of D&E | participants were assessed for the duration of the procedure, an average of 6 minutes | 
| Ease of Mechanical Dilation | Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E | participants were assessed for the duration of the procedure, an average of 6 minutes | 
| Complications From Procedure | Patient having any complication, including hospitalizations transfusions additional unplanned procedures | assessed immediately after completion of D&E and at 1 week and 1 month post-procedure | 
| Chills (Any) After Day 2 Medication Administration | chills (any) after Day 2 medication administration | assessed immediately after administration of day 2 medication | 
| Patient Satisfaction With Cervical Prep | Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home. | patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days | 
| Physician Satisfaction With Cervical Preparation | Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure. | physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abortion, induced