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The objective of the project will be to assess whether this technology(PPIUCD inserter) is effective and if its use can be recommended to other women in India and around the world. Post Partum Family Planning method

Proof of concept study to assess the safety acceptability (provider satisfaction, consumer comfort), and feasibility of PPIUCD inserter. - PPIUCD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/03/005619
Enrollment
70
Registered
2015-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Pregnant women willing to get PPIUCD insertion after delivery.

Interventions

Intervention1: PPIUCD inserter: The IUD itself is NOT investigational. Only the tube of silastic (same material as for interval insertions) by which the IUD is introduced into the uterus is new. Cont

Sponsors

USAIDUnited States Agency for International Development
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: : women who request a PPIUD insertion during ANC period, at the time of delivery or immediately afterwards, as well as meet overall medical eligibility criteria for the immediate PPIUCD services WHO - IUD Medical Eligibility Criteria.

Exclusion criteria

Exclusion criteria: • Participants with ruptured membranes more than 18 hours prior to delivery. • Diagnosis of chorio-amnionitis at the time of delivery. • Unresolved postpartum hemorrhage. • Beyond 48 hrs post partum. • Undergone caesarean section.

Design outcomes

Primary

MeasureTime frame
Ability to successfully place PPIUD at the fundus - Evidence of uterine perforation/trauma immediately after the insertion. - Providerâ??s ease of insertion â?? immediately after insertion. - Participants complaint of pain at insertion. Timepoint: USG will be performed immediately after insertion to check for Fundal placement of IUCD. Outcome will be assessed immediately after PPIUCD insertion. for pain and for provider satisfaction after the insertion is done. Secondary outcome will be assessed during Follow up visit.

Secondary

MeasureTime frame
Clinical outcome of participant during first follow- up. - Participantâ??s overall satisfaction. - Expulsion of the PPIUD. - Removal of the PPIUD. Timepoint: immediatly after insertion to 6 weeks of PPIUD insertion

Countries

India

Contacts

Public ContactDr Sharad Singh

Population Services International India

ssingh@psi.org.in09873722214

Outcome results

None listed

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