For many women, undergoing a manual vacuum aspiration (MVA) can be a painful and distressing experience. Despite being a common procedure used for early pregnancy loss management, pain control options are often limited, costly, or difficult to administer. What if there were a simple, low-cost, reusable solution to make pain relief more accessible?

Enter the CHLOE-SED Study, a groundbreaking clinical trial in Western Kenya that aims to validate an innovative syringe extension device (SED) designed to improve paracervical analgesia during gynecologic procedures. If successful, this device could transform pain management for women undergoing MVA and similar procedures, especially in low-resource settings.

The Problem: Limited Options for Pain Relief

Paracervical blocks—local anesthetic injections administered near the cervix—are a widely used method to reduce pain during MVA. However, administering these injections with a standard spinal needle can be challenging, sometimes requiring multiple attempts and causing discomfort to patients. In resource-limited settings, access to effective pain management tools is even more constrained.

The CHLOE-SED device is designed to change this. By providing a cost-effective, non-invasive extension for syringes, it allows healthcare providers to administer paracervical anesthesia more easily and effectively. The study is investigating whether this device offers the same or better pain relief as traditional methods—while being safer, more efficient, and more acceptable to both patients and providers.

How the Study Works

Launched in July 2021, the study is being conducted at Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH) and Kisii Teaching and Referral Hospital (KTRH). It follows a randomized controlled trial (RCT) design, where women undergoing MVA are randomly assigned to receive a paracervical block using either:

🔹 The experimental syringe extension device (CHLOE-SED)
🔹 The standard spinal needle (control group)

The primary focus? Measuring patient pain levels during the procedure and evaluating whether the new device provides non-inferior or superior pain relief compared to the conventional approach.

Beyond the Clinical Trial: Listening to Women & Providers

Understanding patient and provider experiences is critical to the success of any new medical device. That’s why this study goes beyond clinical measurements and incorporates qualitative research:

🔹 Four focus group discussions (FGDs) with Kenyan women to understand their experiences and preferences for pain control during MVA.
🔹 Two FGDs with MVA providers to gather insights on the effectiveness and usability of the device.

By combining scientific evaluation with real-world feedback, the study aims to refine and improve the CHLOE-SED device to ensure it meets the needs of both patients and healthcare professionals.

Who Is Participating?

The study will include 21 trained MVA providers and 210 women undergoing MVA across the two study sites. In addition, the FGDs will engage 48 participants (both patients and providers) to gather valuable insights on pain management and device usability.

Why It Matters

Access to affordable, effective pain management is a key component of women’s reproductive health rights. If the CHLOE-SED device proves to be safe and effective, it could:

✅ Reduce pain and discomfort during gynecologic procedures
✅ Increase access to quality care for women in resource-limited settings
✅ Empower healthcare providers with a simple and reliable tool
✅ Pave the way for future innovations in reproductive health technology

The Road Ahead

The CHLOE-SED Study is more than just a clinical trial—it’s a step toward ensuring that women in Kenya and beyond have access to dignified, pain-free reproductive healthcare. By validating a low-cost, reusable device, this research could revolutionize how pain relief is provided during gynecologic procedures worldwide.

🔹 Study enrollment is ongoing.
🔹 Results will inform future policy and clinical guidelines.
🔹 The impact could be felt far beyond Kenya, shaping global approaches to gynecologic care.

With continued research and innovation, safe and effective pain management can become a standard, not a privilege. And for thousands of women, that could make all the difference.