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Safety and Efficacy of Immediate Post Placental IUD Insertion in Patients Undergoing Cesarean Delivery

NCT04630548 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-11-16

No results posted yet for this study

Summary

Sixty six women who plan to deliver a live birth singleton via cesarean delivery who desire a Copper IUD for postpartum contraception will be approached for study participation thenvwill be randomized equally into two groups using computer generated numbers.

Group (A): (n=33) women IUD insertion post placental delivery (within 10mins) Group (B): (n=33) women IUD insertion post puerperal ( 6 to 8 weeks postpartum). Primary outcome will include IUD expulsion rate in both groups. Secondary outcomes will include other complications rates: missed threads (not seen by speculum examination), displaced IUD (more than 2 cm from the fundus in ultrasound), heavy puerperal bleeding, abdominal discomfort), Pregnancy rate, Discontinuation of the IUD usage and Satisfaction rate.

Conditions

  • IUD

Interventions

DEVICE

Intrauterine copper device

The obstetrical team will identify subjects who present in labor who meet the criteria and express interest in intrauterine contraception. Immediately after cesarean delivery, consented subjects will be randomized to immediate post placental IUD placement within 10 minutes or IUD placement at their routine standard postpartum visit (6 to 8 weeks postpartum).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • moutaz M ELsherbini, MD · assistant professor (faculty of medicine -Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-03-30
Completion
2022-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630548 on ClinicalTrials.gov