A novel method for post-partum IUD insertion
The impact of unplanned or mistimed pregnancies is a health risk for the mother and the child and places a huge financial burden on societies ($21B in US alone). Contraceptives, in all forms, are designed to alleviate this but 84% of modern contraceptive needs are unmet globally, and the burden is worsening as populations grow. Intrauterine Devices (IUDs) are highly effective long-acting removable contraceptives (LARCs) with low failure rates (0.2% - 0.8%). Though scientific evidence exists which supports the efficacy of commercially available IUDs, clinicians do not recommend nor provide IUD insertion immediately postpartum, due to its high expulsion rate (9% - 30%) from the uteri of post-placental (PP), postpartum mothers. Most women say this happens during daily activities. This is due to the structure of the IUD no longer confining to the shape of the uterus and hence falling off due to the contractile forces of the uterus and the gravitational force acting on the IUD.
The objective of this project is to develop a safe, efficient and effective method of tethering IUDs to fundal walls of postpartum females, such that the IUD remains securely attached to the fundus through contractile and gravitational forces (~0.49 mN ) during the puerperal period (4 to 6 weeks PP delivery). This will drastically reduce IUD expulsion rates while eliminating the need for the patient to return to her healthcare provider specifically for the IUD implantation procedure in the post puerperal period. IUD tethering was performed using ex-vivo tissue models to establish the safety and efficacy of the method (device). Analysis was conducted to find the maximum insertion force required and optimum possible retention forces by the tissue-suture interaction in a dynamic loading condition for two different types of insertions, namely linear and spiral, and indicated that V-LOC 3-0 Gauge suture paired with a 25 Gauge spiral hypodermic needle gives the maximum retention force. A comprehensive survey established clinician satisfaction with the device and ease of use.