TerminatedNot Applicable

Paracervical Block for Pain Control With Osmotic Dilator Placement

United States14 participantsStarted 2015-04-02

Plain-language summary

Cervical dilators are frequently used for preparation prior to second trimester surgical abortion. While their use decreases complications associated with surgical abortion, their placement is often uncomfortable for the patient. Currently there are no proven methods for reducing pain during osmotic dilator placement. The use of numbing medication around the cervix (paracervical block) may decrease this placement pain.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * voluntarily seeking surgical pregnancy termination * gestational age on day of study 14w0d to 23w6d confirmed by pelvic ultrasound with a viable pregnancy (no fetal demise diagnosed) * eligible for second trimester D\&E * having osmotic dilators placed for cervical preparation the day prior to D\&E * able and willing to give informed consent and agree to terms of the study * able to speak and read English or Spanish Exclusion Criteria: * took any prescription or illegal drugs 24 hours prior to the appointment * drank alcohol 12 hours prior to the appointment * took any over the counter pain medications 12 hours prior to the appointment other than the standard 800mg of Ibuprofen * contraindications to osmotic dilators * allergic reaction or hypersensitivity to NSAIDs or lidocaine * untreated acute cervicitis or pelvic inflammatory disease * weight \<100 pounds

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain at Time of Osmotic Dilator Placement

Timeframe: Within 5 minutes of PCB or sham procedure

Trial details

NCT IDNCT02354092

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08-25

Results submitted2018-09-24

View on ClinicalTrials.gov More Abortion Late trials