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Completed

NCT Number: NCT01751087

Cervical Preparation Before Dilation and Evacuation

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Other

oral mifepristone 200 mg on Day 1.

Other names: Mifeprex

Misoprostol

Drug

buccal misoprostol 400 mcg on Day 2

Other names: Cytotec

Osmotic Dilators

Device

osmotic dilators on Day 1

Other names: laminaria, Dilapan-S

Placebo

Other

placebo for mifepristone, on day 1

Other names: vitamin C 500 mg

Primary outcomes

  1. Operative Time

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

    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

Secondary outcomes

  1. Initial Cervical Dilation

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

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

  2. Ability to Complete the D&E on the First Attempt

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

    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.

  3. Need for Mechanical Dilation

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

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

  4. Ease of Mechanical Dilation

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

    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

  5. Complications From Procedure

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

    Patient having any complication, including hospitalizations transfusions additional unplanned procedures

  6. Chills (Any) After Day 2 Medication Administration

    Time frame: assessed immediately after administration of day 2 medication

    chills (any) after Day 2 medication administration

  7. Patient Satisfaction With Cervical Prep

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

    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.

  8. Physician Satisfaction With Cervical Preparation

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

    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.

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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