Protocol No: ECCT/19/03/01 Date of Protocol: 01-01-2019

Study Title:

Validation of re-usable, low cost syringe extension device for the provision of paracervical analgesia during gynecological procedures

Study Objectives:
Laymans Summary:

Women who are having a miscarriage, are usually treated by emptying the uterus. One of the ways to achieve this is a procedure that sucks out the non viable pregnancy called Manual Vacuum Aspiration (MVA) and many in Kenya refer to this procedure with the Kiswahili term "Kuoshwa tumbo".

This procedure causes considerable pain, one way of avoiding pain includes the administration of a numbing injection (LA) to the cervix. However due to the position of the cervix in the birth canal, administration of this injection requires a super long needle that was designed for giving spinal anaesthesia. The unavailability and cost of the spinal needle has led to many women having this procedure with inadequate pain control.

We have invented the Chloe Syringe Extension Device (SED), a low cost reusable gadget, that makes it possible to give a numbing injection to the cervix without needing a spinal needle.

For the purpose of this study, the Chloe SED was manufactured in Nairobi by 3D printing.

In this study we compared pain relief obtained by giving the numbing injection with the spinal needle, to that obtained with our invention.

The results indicate that the pain relief obtained by Chloe SED is the same as that obtained by the spinal needle.

We conclude that Chloe SED is a good substitute to the spinal needle in giving the numbing injection.

We intend to use this results to design a bigger study to establish more information on the suitability of the gadget on giving the numbing injection

Abstract of Study:

In many rural clinics providing women’s health services, paracervical block is impossible to perform due to the high cost of necessary tools (spinal needle, needle extender). In these situations, women undergo manual vacuum aspiration (MVA) and other gynecologic procedures without paracervical analgesia. We have developed a low-cost, reusable syringe extension device for the provision of paracervical analgesia during MVA. We propose to validate functionality of the device and collect user feedback from women’s health providers and patients at four sites in Kisumu, Kenya.