Overview

This trial is active, not recruiting.

Condition abortion, induced
Treatments mifepristone, misoprostol, osmotic dilators, placebo
Sponsor Planned Parenthood League of Massachusetts
Collaborator Society of Family Planning
Start date January 2013
End date February 2014
Trial size 300 participants
Trial identifier NCT01751087, 9-500-25.1, NCT01799928, SFPRF6-MS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Other)
Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
osmotic dilators laminaria
osmotic dilators on Day 1
placebo vitamin C 500 mg
placebo for mifepristone, on day 1
placebo vitamin B12 500 mcg
placebo for misoprostol, on day 2
(Active Comparator)
Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol Cytotec
buccal misoprostol 400 mcg on Day 2
osmotic dilators laminaria
osmotic dilators on Day 1
placebo vitamin C 500 mg
placebo for mifepristone, on day 1
(Active Comparator)
Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
mifepristone Mifeprex
oral mifepristone 200 mg on Day 1.
osmotic dilators laminaria
osmotic dilators on Day 1
placebo vitamin B12 500 mcg
placebo for misoprostol, on day 2

Primary Outcomes

Measure
Operative time
time frame: 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

Measure
initial cervical dilation
time frame: measured immediately before start of D&E
ability to complete the D&E on the first attempt
time frame: assessed after completion of D&E
need for mechanical dilation
time frame: assessed after completion of D&E
ease of mechanical dilation
time frame: assessed after completion of D&E
complications from procedure
time frame: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
pain with procedure
time frame: assessed after completion of D&E
side effects
time frame: assessed after dilator insertion, after day 1 medication, after day 2 medication and after D&E procedure
patient acceptability of dilation method
time frame: assessed after completion of D&E procedure
provider acceptability of dilation method
time frame: assessed after completion of D&E procedure

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official 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.
Principal investigator Principal Investigator, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Planned Parenthood League of Massachusetts.