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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01751087
Other study ID # 9-500-25.1
Secondary ID SFPRF6-MS
Status Completed
Phase N/A
First received December 12, 2012
Last updated January 27, 2016
Start date January 2013
Est. completion date June 2014

Study information

Verified date January 2016
Source Planned Parenthood League of Massachusetts
Contact n/a
Is FDA regulated No
Health authority United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Other known NCT identifiers
  • NCT01799928

Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date June 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Mifepristone
oral mifepristone 200 mg on Day 1.
Drug:
misoprostol
buccal misoprostol 400 mcg on Day 2
Device:
Osmotic dilators
osmotic dilators on Day 1
Other:
placebo
placebo for mifepristone, on day 1
placebo
placebo for misoprostol, on day 2

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Family Planning Associates Chicago Illinois
United States Planned Parenthood of New York City New York New York
United States Magee Women's Hospital Pittsburgh Pennsylvania
United States Lovejoy Surgical Center Portland Oregon
United States San Francisco General Hospital San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Planned Parenthood League of Massachusetts Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Initial Cervical Dilation Measured at the time of procedure (immediately before the start of D&E) participants were assessed during cervical dilation process, average time of 1 minute No
Secondary 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. participants were assessed for the duration of the procedure, an average of 6 minutes No
Secondary Need for Mechanical Dilation Assessed on Day of procedure. Assessed immediately after completion of D&E participants were assessed for the duration of the procedure, an average of 6 minutes No
Secondary 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 participants were assessed for the duration of the procedure, an average of 6 minutes No
Secondary Complications From Procedure Patient having any complication, including hospitalizations transfusions additional unplanned procedures assessed immediately after completion of D&E and at 1 week and 1 month post-procedure Yes
Secondary Chills (Any) After Day 2 Medication Administration chills (any) after Day 2 medication administration assessed immediately after administration of day 2 medication No
Secondary 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. patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days No
Secondary 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. physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes No
See also
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Completed NCT02277249 - Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion N/A
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Completed NCT00677755 - Medical Abortion for Emergency Contraception Failure N/A
Completed NCT02279914 - Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial N/A
Completed NCT01597726 - Cervical Priming Before Dilation & Evacuation N/A
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Completed NCT02318212 - Dilapan-S / Dilasoft E-Registry in Induced Abortion N/A
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Completed NCT00330993 - Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation Phase 2
Completed NCT00382538 - Mifepristone and Mid-Trimester Termination of Pregnancy N/A
Completed NCT03080493 - Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial Phase 4
Completed NCT02485444 - Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion Phase 4
Completed NCT00969982 - Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP)) N/A
Recruiting NCT02480543 - Different Routes of Misoprostol Prior to First Trimester Surgical Abortion Phase 4
Completed NCT00870272 - Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP) N/A
Completed NCT02048098 - Misoprostol for Second Trimester Termination of Pregnancy Phase 3