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CompletedNCT01751087Updated Feb 24, 2016Results posted

Cervical Preparation Before Dilation and Evacuation

An interventional study of Mifepristone and misoprostol in Abortion, Induced, sponsored by Planned Parenthood League of Massachusetts. Completed at 7 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-24.

Sponsored by Planned Parenthood League of Massachusetts · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.
02

Conditions studied

  • Abortion, Induced

Keywords

  • abortion, induced
03

In context

Dilatation, Pathologic

260 studies on the registry are indexed under Dilatation, Pathologic; 43 are open to participants now.

This study's enrollment of 300 is above the median of 75 across 186 interventional studies indexed under Dilatation, Pathologic.

Browse Dilatation, Pathologic studies →

Lead sponsor

Planned Parenthood League of Massachusetts is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Other
    Osmotic dilators + placebo (vit c) + placebo (vit B12)

    Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.

    Device: Osmotic dilators · Other: placebo

  • Active comparator
    Osmotic dilators + placebo (vit c) + misoprostol

    Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.

    Drug: misoprostol · Device: Osmotic dilators · Other: placebo

  • Active comparator
    Osmotic dilators + mifepristone + placebo (vit B12)

    Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.

    Other: Mifepristone · Device: Osmotic dilators · Other: placebo

Interventions

  • OtherMifepristone

    oral mifepristone 200 mg on Day 1.

    Also known as: Mifeprex

  • Drugmisoprostol

    buccal misoprostol 400 mcg on Day 2

    Also known as: Cytotec

  • DeviceOsmotic dilators

    osmotic dilators on Day 1

    Also known as: laminaria, Dilapan-S

  • Otherplacebo

    placebo for mifepristone, on day 1

    Also known as: vitamin C 500 mg

  • Otherplacebo

    placebo for misoprostol, on day 2

    Also known as: vitamin B12 500 mcg

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes

Secondary outcomes

  1. Initial Cervical Dilation

    Measured at the time of procedure (immediately before the start of D\&E)

    Time frame: participants were assessed during cervical dilation process, average time of 1 minute

  2. 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.

    Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes

  3. Need for Mechanical Dilation

    Assessed on Day of procedure. Assessed immediately after completion of D\&E

    Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes

  4. 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

    Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes

  5. Complications From Procedure

    Patient having any complication, including hospitalizations transfusions additional unplanned procedures

    Time frame: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure

  6. Chills (Any) After Day 2 Medication Administration

    chills (any) after Day 2 medication administration

    Time frame: assessed immediately after administration of day 2 medication

  7. 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.

    Time frame: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days

  8. 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.

    Time frame: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes

07

Results

Posted Feb 24, 2016
Limitations and caveats
Limitations include inadequate sample size to measure complications as a primary outcome and reliance on outcomes that measure efficacy of the cervical preparation rather than its direct effect on overall safety.

Participant flow

Recruitment period: February 2013-February 2014 Number of recruitment sites: 7 Types of location: medical clinic (3), hospital-based (4)

Participant flow — Overall Study
MilestoneOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Started100100100
Completed9910099
Not completed101
Withdrew: Withdrawal by subject100
Withdrew: Physician decision001

Outcome measures

PrimaryOperative 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

Time frame:
participants were assessed for the duration of the procedure, an average of 6 minutes
Reported as:
Mean · minutes
Operative Time
minutesOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Operative Time6.27 ± 3.56.28 ± 4.65.53 ± 2.9
SecondaryInitial Cervical Dilation

Measured at the time of procedure (immediately before the start of D\&E)

Time frame:
participants were assessed during cervical dilation process, average time of 1 minute
Reported as:
Mean · centimeters
Initial Cervical Dilation
centimetersOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Initial Cervical Dilation2.2 ± 0.52.5 ± 0.92.4 ± 0.5
SecondaryAbility 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.

Time frame:
participants were assessed for the duration of the procedure, an average of 6 minutes
Reported as:
Number · participants
Ability to Complete the D&E on the First Attempt
participantsOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Ability to Complete the D&E on the First Attempt989898
SecondaryNeed for Mechanical Dilation

Assessed on Day of procedure. Assessed immediately after completion of D\&E

Time frame:
participants were assessed for the duration of the procedure, an average of 6 minutes
Reported as:
Number · participants
Need for Mechanical Dilation
participantsOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Need for Mechanical Dilation26 (17.8 to 35.3)9 (3.4 to 14.8)16 (8.9 to 23.4)
SecondaryEase 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

Time frame:
participants were assessed for the duration of the procedure, an average of 6 minutes
Reported as:
Number · participants
Ease of Mechanical Dilation
participantsOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Ease of Mechanical Dilation641
SecondaryComplications From Procedure

Patient having any complication, including hospitalizations transfusions additional unplanned procedures

Time frame:
assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
Reported as:
Number · participants
Complications From Procedure
participantsOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Complications From Procedure1022
SecondaryChills (Any) After Day 2 Medication Administration

chills (any) after Day 2 medication administration

Time frame:
assessed immediately after administration of day 2 medication
Reported as:
Number · participants
Chills (Any) After Day 2 Medication Administration
participantsOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Chills (Any) After Day 2 Medication Administration12 (5.7 to 18.6)39 (29.4 to 48.6)18 (10.6 to 25.8)
SecondaryPatient 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.

Time frame:
patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
Reported as:
Number · participants
Patient Satisfaction With Cervical Prep
participantsOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Patient Satisfaction With Cervical Prep728080
SecondaryPhysician 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.

Time frame:
physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes
Reported as:
Number · participants
Physician Satisfaction With Cervical Preparation
participantsOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Physician Satisfaction With Cervical Preparation71 (62.9 to 80.6)78 (70.7 to 86.8)85 (80.0 to 93.5)

Adverse events

Collected over 1 month post-procedure. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)—2/99 (2%)8/99 (8.1%)
Osmotic Dilators + Placebo (Vit c) + Misoprostol—1/100 (1%)1/100 (1%)
Osmotic Dilators + Mifepristone + Placebo (Vit B12)—1/99 (1%)1/99 (1%)
Most frequent serious events
Most frequent serious events
EventOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Hospitalization for bleedingReproductive system and breast disorders2/990/1001/99
Hospitalization for bleeding + HysterectomyReproductive system and breast disorders0/991/1000/99
Most frequent other events
Most frequent other events
EventOsmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)
Intrauterine tamponade or cervical stay suturesReproductive system and breast disorders3/990/1000/99
cervical laceration requiring suturesReproductive system and breast disorders3/990/1000/99
uterine re-aspirationReproductive system and breast disorders2/991/1001/99

Baseline characteristics

Age, Continuous
Age, Continuous(years)Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)Total
Mean24.6 ± 5.725.9 ± 5.925.3 ± 5.825.25 ± 5.8
Sex: Female, Male
Sex: Female, Male(Participants)Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)Total
Female100100100300
Male0000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)Total
Hispanic or Latina19182259
African American or black394836123
White or European American31222982
Other11121336
Region of Enrollment
Region of Enrollment(participants)Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)Osmotic Dilators + Placebo (Vit c) + MisoprostolOsmotic Dilators + Mifepristone + Placebo (Vit B12)Total
United States100100100300
08

Study locations

7 sites
  • San Francisco General Hospital
    San Francisco, California 94110, United States
  • Family Planning Associates
    Chicago, Illinois 60630, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Planned Parenthood of New York City
    New York, New York 10012, United States
  • Lovejoy Surgical Center
    Portland, Oregon 97210, United States
  • Magee Women's Hospital
    Pittsburgh, Pennsylvania 15213, United States
09

References and documents

Publications

  • Goldberg AB, Fortin JA, Drey EA, Dean G, Lichtenberg ES, Bednarek PH, Chen BA, Dutton C, McKetta S, Maurer R, Winikoff B, Fitzmaurice GM. Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):599-609. doi: 10.1097/AOG.0000000000000977. PubMed 26196084 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01751087
Lead sponsor
Planned Parenthood League of Massachusetts
Collaborators
Society of Family Planning
Responsible party
Sponsor
First posted
Dec 17, 2012
Start date
Jan 2013
Primary completion
Feb 2014
Completion
Jun 2014
Results posted
Feb 24, 2016
Last update
Feb 24, 2016

Study contacts

Principal Investigator, MD, MPH
principal investigator · Planned Parenthood League of Massachusetts

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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