Comparative study on the safety and acceptability of post-delivery intrauterine contraceptive device using standard approach (Forceps) and a new device (Inserter).

Single blinded, randomized, comparative study on the safety and acceptability of PPIUCD insertion using Kellyâ??s forceps and a dedicated PPIUCD inserter

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/03/006771

Enrollment

500

Registered

2016-03-30

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

None listed

Interventions

Intervention1: PPIUCD Inserter: New Device to be used for post partum IUCD insertion Control Intervention1: Kellys forceps: Currently providers are using forceps for PPIUD insertion

Eligibility

Inclusion criteria

Inclusion criteria: Women who request a PPIUCD 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 - IUCD Medical Eligibility Criteria and gives a written and an audio-visual consent as per the protocol.

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 postpartum. Undergone caesarean section.

Design outcomes

Primary

Measure	Time frame
Immediate Outcomes: - Ability to successfully place PPIUCD at the fundus - Evidence of uterine perforation/trauma immediately after the insertion. - Providerâ??s assessment of ease of insertion â?? immediately after insertion. - Participants pain perceptions at insertion. Timepoint: Immediately after insertion	—

Secondary

Measure	Time frame
Secondary Outcomes: - Clinical outcome of participant during first follow- up. - Participantâ??s overall satisfaction. - Expulsion of the PPIUCD. - Removal of the PPIUCD. Timepoint: 6-8 weeks after PPIUCD insertion	—

Countries

India

Contacts

Public ContactDr Sharad Singh

Population Services International- India

ssingh@psi.org.in91-9873722214

Outcome results