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Insertion of a copper IUD after immediate vaginal delivery: comparison between placement with and without the aid of ultrasound

Copper IUD insertion after immediate vaginal delivery: comparison of standard technique vs. ultrasound-guided technique - a randomized double-blind study carried out in university hospital

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10mn89c6
Enrollment
Unknown
Registered
2024-02-16
Start date
2023-10-02
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Family Development Planning

Interventions

Intervention group, postpartum women who have had a normal delivery and will undergo the insertion of an intrauterine copper device through an ultrasound guided method. Control group, postpartum women
E07.190.250.510
E01.370.350.850

Sponsors

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Pregnant women with a single fetus. Age over 18 years old. Gestational age greater than or equal to 34 weeks. Pregnant women admitted to an obstetric center in early labor (< 4 cm cervical dilation) or under labor analgesia, able to understand the study presentation, its justification and sign the informed consent form. Pregnant women expressing a desire to insert an IUD prior to the study inclusion interview

Exclusion criteria

Exclusion criteria: Puerperal sepsis. Chorioamnionitis. Distorted uterine cavity (submucous myoma, Mullerian malformations). Cervical cancer. Fever (oral temperature = 37.8º C) during labor. Rupture of ovular membranes = 18 hours. Puerperal hemorrhage when any type of intervention is performed for puerperal hemorrhage: Manual massage, Administration of crystalloid for volume expansion or blood derivatives. Use of medications such as oxytocin, ergotamine, misoprostol, tranexamic acid. Use of intrauterine balloon. Surgical treatment such as vessel ligation and B-Lynch.

Design outcomes

Primary

MeasureTime frame
It is expected to find a 50% reduction in the expulsion rate of copper intrauterine devices inserted through the ultrasound-guided method after immediate vaginal delivery—

Secondary

MeasureTime frame
No secondary outcomes are expected—

Countries

Brazil

Contacts

Public ContactMarcos Okido

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

cep@hcrp.usp.br+55 016 3602-1000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)