Authorised Therapeutic confirmatory (Phase III) abortion

Pain relief for medical abortion after 13 weeks gestations

EU CTIS ID: 2025-524599-52-03

What this study is testing

To reduce maximum pain experience during second trimester induced abortion

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • The subject has given their written consent to participate in the trial.
  • 18 years or older
  • singleton viable gestation at 13 weeks + 0 days or beyond according to ultrasound
  • willing to accept Paracervical block for pain relief
  • willing to accept intravenous patient controlled analgesia during the abortion
  • With sufficient knowledge of local language (or with certified interpreter on site) or English

You likely can't join if

  • Allergy or contraindication to: paracetamol, non-steroidal anti-inflammatory drugs, oxycodone hydrochloride, mifepristone, misoprostol or any local anesthetic
  • Breastfeeding
  • Use of any anxiolytics including benzodiazepines or any other sleep augmentor/medication
  • Severe liver dysfunction/injury (for ropivacaine according to SmPC)
  • Allergy or hypersensitivity against ropivacaine or any local anestesia of amide type or any other content of preparation. (for ropivacaine according to SmPC)
  • Chronic obstructive lung disease
See the full eligibility criteria
Who can join
  • The subject has given their written consent to participate in the trial.
  • 18 years or older
  • singleton viable gestation at 13 weeks + 0 days or beyond according to ultrasound
  • willing to accept Paracervical block for pain relief
  • willing to accept intravenous patient controlled analgesia during the abortion
  • With sufficient knowledge of local language (or with certified interpreter on site) or English
What rules you out
  • Allergy or contraindication to: paracetamol, non-steroidal anti-inflammatory drugs, oxycodone hydrochloride, mifepristone, misoprostol or any local anesthetic
  • Breastfeeding
  • Use of any anxiolytics including benzodiazepines or any other sleep augmentor/medication
  • Severe liver dysfunction/injury (for ropivacaine according to SmPC)
  • Allergy or hypersensitivity against ropivacaine or any local anestesia of amide type or any other content of preparation. (for ropivacaine according to SmPC)
  • Chronic obstructive lung disease
  • Cor pulmonale
  • Uncontrolled asthma
  • paralytic ileus
  • Hypovolemia (for ropivacaine according to SmPC)
  • Allergy or hypersensitivity to fentanyl or other opioids or any other content of preparation (for fentanyl according to SmPC)
  • Disturbances in breathing or brain function (for fentanyl according to SmPC)
  • Use of MAO-inhibitors (for oxycodone hydrochloride according to SmPC)
  • Use of flukonazole, vorikonazole, cimetidine, valproat, ritonavir (interactions).
  • Bleeding disorder or anti-coagulant treatment preventing deep injections.
  • Previous conization (may affect time to expulsion and pain)
  • Severe emotional instability deemed to prevent participation

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.