Feedback collection of modified PPIUD (TCu 380A) with inserter
Not Applicable
- Registration Number
- CTRI/2023/10/058900
- Lead Sponsor
- Pregna International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Primiparous or multiparous women delivering vaginally
and willing for postpartum IUD insertion.
- Consenting and willing for Copper T IUD.
- Insertion within 48 hours following delivery
Exclusion Criteria
-Prolonged rupture of membrane ( >18 h) prior to delivery.
-Diagnosis of chorio-amnionitis at time of delivery (as defined by the Provider)
-Unresolved postpartum hemorrhage.
-Extensive genital trauma.
-Coagulopathies.
-Distorted uterine cavity.
-Cesarean delivery
-Puerperal sepsis
-After 48 hrs of delivery
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To collect user feedback to evaluate provider acceptability and ease of use <br/ ><br>of modified PPIUD insertion system.Timepoint: Immediately post insertion
- Secondary Outcome Measures
Name Time Method Intrauterine placement of IUDTimepoint: Immediately post insertion