Comparison of different ways to insert the Copper IUD in women after vaginal delivery

Not Applicable

Not yet recruiting

• Conditions: Contraception; Intrauterine Devices; Postpartum Period; E02.875.194

• Registration Number: RBR-4j62jv6
• Lead Sponsor: Hospital da Mulher Prof. Dr. J. A. Pinotti-Caism/Unicamp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-12
• Study Completion: 2022-12-30
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Pregnant women between 18 and 43 years old; hemoglobin greater than 8.0 mg/dl during prenatal care; single pregnancy; desire to use IUD as a contraceptive method

Exclusion Criteria

Pregnant women with diagnosis or suspicion of ovular membrane infection; diagnosis of any other infection (anywhere); active sexually transmitted infection; uterine malformation (bicornuate, septate uterus); uterine fibroids that deform the cavity; pregnant women with scheduled cesarean

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ower rate of IUD expulsion in women who received the manually inserted device as assessed by transvaginal ultrasound 40 to 60 days after delivery. At least 25% fewer expulsions are expected in the manual insertion group.

Secondary Outcome Measures

Name	Time	Method
evel of satisfaction with the copper IUD above 70%, assessed by the Likert scale applied in the review visit 40 to 60 days after delivery, regardless of the insertion method.;Lower level of pain in patients who received the copper IUD inserted with forceps, assessed by the Visual Analog Scale with a graduation from 0 (no pain) to 10 (worst pain ever experienced). At least 2 less pain points are expected.