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Feedback collection of modified PPIUD (TCu 380A) with inserter

Feedback collection for the modified Postpartum Intrauterine Device (PPIUD) (TCu 380A) with inserter in postpartum women who underwent vaginal delivery. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058900
Enrollment
2000
Registered
2023-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Pregna International Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To collect user feedback to evaluate provider acceptability and ease of use of modified PPIUD insertion system.Timepoint: Immediately post insertion—

Secondary

MeasureTime frame
Intrauterine placement of IUDTimepoint: Immediately post insertion—

Countries

India

Contacts

Public ContactRanjit Gaikwad

Pregna International Ltd.

sharad.singh@pregna.com9873722214

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026