## Protocol Section
### Identification Module
**NCT ID:** NCT01436279

**Acronym:** SaMi2

**Brief Title:** Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

**Official Title:** Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

#### Organization Study ID Info
**ID:** H-31032
#### Organization
**Class:** OTHER
**Full Name:** Boston University
#### Secondary ID Infos
**Domain:** Society of Family Planning
**ID:** AU 6003109
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2013-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-06-14

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-06-14

**Type:** ACTUAL

**Results First Submit Date:** 2017-04-11

**Results First Submit QC Date:** 2017-05-16

#### Start Date
**Date:** 2011-07

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2011-09-19
**Type:** ESTIMATED
**Study First Submit Date:** 2011-09-15
**Study First Submit QC Date:** 2011-09-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Society of Family Planning

#### Lead Sponsor

**Class:** OTHER

**Name:** Boston University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.

### Conditions Module

**Conditions:**

- Cervical Preparation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

**Intervention Names:**

- Drug: Mifepristone

**Label:** Mifepristone + misoprostol

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placed 20-24 hours prior to procedure

**Intervention Names:**

- Device: osmotic dilators

**Label:** Osmotic dilators

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mifepristone + misoprostol

**Description:** 200 mg po 20-24 hours prior to the procedure

**Name:** Mifepristone

**Other Names:**

- Mifeprex

- RU-486

- Mifegyne

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Osmotic dilators

**Description:** osmotic dilators placed in the cervix 20-24 hours prior to the procedure

**Name:** osmotic dilators

**Other Names:**

- Laminaria

- Dilapan-S

- Dilapan

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Interval from speculum insertion to speculum removal

**Measure:** Length of Procedure

**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.

#### Secondary Outcomes

**Description:** Interval from initiation of vacuum aspiration to speculum removal

**Measure:** Operative Time

**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

**Description:** Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe

**Measure:** Subject Discomfort Before the Abortion

**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

**Description:** Amount of pain medication used during the procedure: reported as micrograms of fentanyl

**Measure:** Pain Medication (Fentanyl) During the Abortion

**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

**Description:** Amount of pain medication used during the procedure: reported as milligrams of midazolam

**Measure:** Pain Medication (Midazolam) During the Abortion

**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.

**Description:** Cervical dilation at start of procedure

**Measure:** Cervical Dilation Achieved

**Time Frame:** At time of abortion

**Description:** Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported.

**Measure:** Acceptability to Patient

**Time Frame:** After procedure completion

**Description:** Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult."

**Measure:** Difficulty of Procedure

**Time Frame:** After completion of procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Women 18-50 years of age undergoing surgical termination of pregnancy
* English or Spanish speaking
* Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
* Eligible for a dilation and evacuation abortion with local anesthesia and sedation
* Ultrasound for dating purposes done within the last two weeks

Exclusion Criteria:

* Intrauterine infection
* Fetal demise
* Ruptured membranes
* Multiple gestation
* Uterine anomaly or significant distortion of the uterus with fibroids
* BMI greater than 45
* Inability to place osmotic dilators
* Active substance abuse or intoxication
* Adrenal failure, chronic corticosteroid use, anticoagulant usage
* Severe cervicitis, until treated and resolved
* Prior Cesarean section

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Boston University

**State:** Massachusetts

**Zip:** 02130

#### Overall Officials

**Official 1:**

**Affiliation:** Boston Medical Center

**Name:** Sarita Sonalkar, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000021

- Term: Abortifacient Agents, Steroidal

- ID: D000000019

- Term: Abortifacient Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000003280

- Term: Contraceptives, Oral, Synthetic

- ID: D000003276

- Term: Contraceptives, Oral

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000003283

- Term: Contraceptives, Postcoital, Synthetic

- ID: D000003281

- Term: Contraceptives, Postcoital

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000008186

- Term: Luteolytic Agents

- ID: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000008600

- Term: Menstruation-Inducing Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M18300

- Name: Mifepristone

- Relevance: HIGH

- As Found: Debridement

- ID: M18979

- Name: Misoprostol

- Relevance: LOW

- As Found: Unknown

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M6505

- Name: Contraceptives, Postcoital

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000015735

- Term: Mifepristone

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Mifepristone + Misoprostol

**Deaths Num At Risk:** 30

**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Mifepristone: 200 mg po 20-24 hours prior to the procedure

**ID:** EG000

**Other Num at Risk:** 30

**Serious Number At Risk:** 30

**Title:** Mifepristone + Misoprostol

**Group ID:** EG001

**Title:** Osmotic Dilators

**Deaths Num At Risk:** 20

**Description:** Placed 20-24 hours prior to procedure

osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure

**ID:** EG001

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Osmotic Dilators

**Frequency Threshold:** 0

**Time Frame:** 12 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 30

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 50

**Units:** Participants

### Group

**ID:** BG000

**Title:** Mifepristone + Misoprostol

**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

### Group

**ID:** BG001

**Title:** Osmotic Dilators

**Description:** Placed 20-24 hours prior to procedure

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 30

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 50

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 30

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 50

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** Olivera.Vragovic@bmc.org
**Organization:** Boston Medical Center
**Phone:** 617 414 7304
**Title:** Olivera Vragovic
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12
- **Spread:** 
- **Upper Limit:** 17
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 11
- **Spread:** 
- **Upper Limit:** 16
- **Value:** 13.5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7
- **Spread:** 
- **Upper Limit:** 12
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7
- **Spread:** 
- **Upper Limit:** 9.5
- **Value:** 8.5
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.34
- **Upper Limit:** 
- **Value:** 3.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1
- **Upper Limit:** 
- **Value:** 2.9
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 31
- **Upper Limit:** 
- **Value:** 104
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26
- **Upper Limit:** 
- **Value:** 105
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11
- **Upper Limit:** 
- **Value:** 42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5
- **Upper Limit:** 
- **Value:** 56
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Interval from speculum insertion to speculum removal
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.
**Title:** Length of Procedure
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
**ID:** OG000
**Title:** Mifepristone + Misoprostol
##### Group
**Description:** Placed 20-24 hours prior to procedure
**ID:** OG001
**Title:** Osmotic Dilators
#### Outcome Measure 2
**Description:** Interval from initiation of vacuum aspiration to speculum removal
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
**Title:** Operative Time
**Type:** SECONDARY
**Unit of Measure:** minutes
##### Group
**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Mifepristone: 200 mg po 20-24 hours prior to the procedure
**ID:** OG000
**Title:** Mifepristone + Misoprostol
##### Group
**Description:** Placed 20-24 hours prior to procedure

osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure
**ID:** OG001
**Title:** Osmotic Dilators
#### Outcome Measure 3
**Description:** Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
**Title:** Subject Discomfort Before the Abortion
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Mifepristone: 200 mg po 20-24 hours prior to the procedure
**ID:** OG000
**Title:** Mifepristone + Misoprostol
##### Group
**Description:** Placed 20-24 hours prior to procedure

osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure
**ID:** OG001
**Title:** Osmotic Dilators
#### Outcome Measure 4
**Description:** Amount of pain medication used during the procedure: reported as micrograms of fentanyl
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
**Title:** Pain Medication (Fentanyl) During the Abortion
**Type:** SECONDARY
**Unit of Measure:** mcg
##### Group
**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
**ID:** OG000
**Title:** Mifepristone + Misoprostol
##### Group
**Description:** Placed 20-24 hours prior to procedure
**ID:** OG001
**Title:** Osmotic Dilators
#### Outcome Measure 5
**Description:** Amount of pain medication used during the procedure: reported as milligrams of midazolam
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
**Title:** Pain Medication (Midazolam) During the Abortion
**Type:** SECONDARY
**Unit of Measure:** mg
##### Group
**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
**ID:** OG000
**Title:** Mifepristone + Misoprostol
##### Group
**Description:** Placed 20-24 hours prior to procedure
**ID:** OG001
**Title:** Osmotic Dilators
#### Outcome Measure 6
**Description:** Cervical dilation at start of procedure
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** At time of abortion
**Title:** Cervical Dilation Achieved
**Type:** SECONDARY
**Unit of Measure:** mm
##### Group
**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Mifepristone: 200 mg po 20-24 hours prior to the procedure
**ID:** OG000
**Title:** Mifepristone + Misoprostol
##### Group
**Description:** Placed 20-24 hours prior to procedure

osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure
**ID:** OG001
**Title:** Osmotic Dilators
#### Outcome Measure 7
**Description:** Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** After procedure completion
**Title:** Acceptability to Patient
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Mifepristone: 200 mg po 20-24 hours prior to the procedure
**ID:** OG000
**Title:** Mifepristone + Misoprostol
##### Group
**Description:** Placed 20-24 hours prior to procedure

osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure
**ID:** OG001
**Title:** Osmotic Dilators
#### Outcome Measure 8
**Description:** Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult."
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** After completion of procedure
**Title:** Difficulty of Procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Mifepristone: 200 mg po 20-24 hours prior to the procedure
**ID:** OG000
**Title:** Mifepristone + Misoprostol
##### Group
**Description:** Placed 20-24 hours prior to procedure

osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure
**ID:** OG001
**Title:** Osmotic Dilators
### Participant Flow Module
#### Group
**Description:** Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure

Mifepristone: 200 mg po 20-24 hours prior to the procedure
**ID:** FG000
**Title:** Mifepristone + Misoprostol
#### Group
**Description:** Placed 20-24 hours prior to procedure

osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure
**ID:** FG001
**Title:** Osmotic Dilators
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 30
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 30
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True