Recruiting
Phase 2

Osmotic Dilators

Sponsor:

Rush University Medical Center

Code:

NCT07487246

Conditions

Pain Management

Abortion

Second Trimester Abortion

Dilation and Evacuation

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketorolac

oral ibuprofen

Placebo

Lidocaine HCl 1%

Saline

Study Details

Brief summary:

The purpose of this study is to improve pain management for participantswho need osmotic dilators for cervical preparation the day before their second trimester abortion procedure.

Conditions

Pain Management

Abortion

Second Trimester Abortion

Dilation and Evacuation

Study ID

NCT07487246

Start date

Jun 29, 2026

Status verified date

Jul, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

Age >/= 18 years English or Spanish speaking Ability and willingness to sign the informed consent Ability and willingness to comply with the terms of the study including possessing active cell phone with text messaging capabilities Voluntary request for pregnancy termination Ultrasound-confirmed intrauterine pregnancy with an estimated gestational age of 16+0-23+6 weeks gestational age Require osmotic dilator placement one day prior to procedural abortion according to institutional protocol Seeking outpatient abortion services at Rush University Medical Center

Exclusion criteria:

Have taken NSAIDs less than 6 hours prior to their clinic visit Contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria Allergic reaction or sensitivity to NSAIDs History of peptic ulcer or gastrointestinal bleed, history of gastric bypass (RYGB) or recent history in last 6 months of gastric sleeve; history of inflammatory bowel disease (Ulcerative colitis, Crohn's disease) Uncontrolled hypertension, heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease Acute renal failure or chronic renal disease Chronic liver disease History of bleeding diathesis Untreated acute cervicitis or pelvic inflammatory disease Require or request PO benzodiazepine or IV sedation for placement of osmotic dilators Require more than 1 day of osmotic dilators Chronic or current narcotic use Current recreational drug use (excluding cannabis) Require transabdominal/transvaginal injection for induced fetal demise prior to abortion

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Treatment Group

Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac

active comparator: Standard Treatment

Oral ibuprofen with plain 1% lidocaine paracervical block

Interventions

Ketorolac

Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement. Immediately prior to placement of osmotic dilators, a 1% lidocaine + ketorolac paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL ketorolac (30mg) will be administered.

oral ibuprofen

Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.

Placebo

Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.

Lidocaine HCl 1%

Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed in the following fashion: Two milliliters of the analgesic mixture will be placed at the tenaculum site intracervically. After the tenaculum is placed, the remaining 18 mL of the analgesic mixture will be administered at 4 and 8 o'clock at the cervicovaginal reflection.

Saline

Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed.

Primary outcome measure

  • Pain post-osmotic dilator insertion [ Time Frame: After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal ]

Central Contacts and Locations

Central contacts

Cristina MA Barkowski, MSW, DrPH(s)

312-942-6382cristina_m_barkowski@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

More Information

Sponsor

Rush University Medical Center

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • randomized controlled trial
  • osmotic dilators
  • ketorolac
  • paracervical block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-07-06.