Cervical Preparation Before Dilation and Evacuation

NCT01751087 | Completed Results DMC

• 2 other identifiers: 9-500-25.1SFPRF6-MS
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Abortion, Induced

Keywords

abortion, induced

Outcome Measures

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

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

Secondary Outcomes (8)

• Initial Cervical Dilation

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

• Ability to Complete the D&E on the First Attempt

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

• Need for Mechanical Dilation

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

• Ease of Mechanical Dilation

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

• Complications From Procedure

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

Study Arms (3)

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

OTHER

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

Device: Osmotic dilators; Other: placebo

Osmotic dilators + placebo (vit c) + misoprostol

ACTIVE COMPARATOR

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

Osmotic dilators + mifepristone + placebo (vit B12)

ACTIVE COMPARATOR

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

Mifepristone OTHER

oral mifepristone 200 mg on Day 1.

Also known as: Mifeprex

Osmotic dilators + mifepristone + placebo (vit B12)

misoprostol DRUG

buccal misoprostol 400 mcg on Day 2

Also known as: Cytotec

Osmotic dilators + placebo (vit c) + misoprostol

Osmotic dilators DEVICE

osmotic dilators on Day 1

Also known as: laminaria, Dilapan-S

Osmotic dilators + mifepristone + placebo (vit B12); Osmotic dilators + placebo (vit c) + misoprostol; Osmotic dilators + placebo (vit c) + placebo (vit B12)

placebo OTHER

placebo for mifepristone, on day 1

Also known as: vitamin C 500 mg

Osmotic dilators + placebo (vit c) + misoprostol; Osmotic dilators + placebo (vit c) + placebo (vit B12)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead
• Society of Family Planning: collaborator

Study Sites (7)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Family Planning Associates

Chicago, Illinois, 60630, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Planned Parenthood of New York City

New York, New York, 10012, United States

Location

Lovejoy Surgical Center

Portland, Oregon, 97210, United States

Location

Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 26196084 DERIVED

MeSH Terms

Interventions

Mifepristone; Misoprostol; Ascorbic Acid; Vitamin B 12

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds

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.

Results Point of Contact

• Title: Principal Investigator
• Organization: Planned Parenthood League of Massachusetts, Inc.

617.616.1600

Study Officials

• Principal Investigator, MD, MPH

  Planned Parenthood League of Massachusetts

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 24, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-01

Locations

US (7)