Immediate Post-placental Insertion of IUCD During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion

ALshaimaa Aboalhassan Ali200 enrolled

Overview

The aim of current study is to compare the rates of IUCD expulsion and complications in immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean delivery)

Intrauterine devices (IUDs) are among the most effective forms of contraception, offering greater than 99% efficacy per year of use and are completely reversible . Post-placental intrauterine device (IUD) insertion is a safe, convenient, and effective option for postpartum contraception. "Post-placental" refers to insertion within 10-15 minutes of placental delivery, after vaginal or cesarean delivery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

200

Conditions

Mechanical Complication of Intrauterine Device

Interventions

IUCDDRUG

IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age: 18 -45 * Singleton pregnancy at ≥32 weeks gestation at time of enrollment * Voluntarily requesting to IUD placement for postpartum contraception * Able to give consent and agree to the terms of the study Exclusion Criteria: 1. Uterine anomaly that preventing replacement of IUD. 2. Chorioamnionitis (such as prolonged rupture of membranes \>18 hours, prolonged labor \>24 hours, fever \>38C). 3. Puerperal sepsis and unresolved postpartum hemorrhage. 4. IUD allergy (copper). 5. Systemic lupus erythematosus with severe thrombocytopenia

Locations (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

Expulsion

The time until expulsion of the IUD will be defined as the time from insertion until expulsion occurred, if known. If the date of expulsion is not known, this will be documented as the day after the IUD was last known to be in place. If a pregnancy is detected and the IUD is absent (and the participant was unaware of expulsion), the expulsion will be assumed to have occurred at the time of conception, as determined by gestational age on ultrasound. Expulsions will be measured as total expulsions and separately noted whether complete or partial

Time frame: 3 months

Secondary Outcomes

Displacement

The displacement is diagnosed by doing trans-vaginal ultrasound that showed IUCD that displaced up or down word

Time frame: 3 months

Infection

The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study.

Time frame: 3 months

Bleeding

Irregular bleeding (including spotting, light bleeding, heavy or longer menstrual period) are common in the first 3 months and may persist.

Time frame: 3 months

Perforation

The diagnosis of a perforation may be made by a transvaginal sonogram that shows no IUD within the uterus and an abdominal radiograph that show IUD within the abdominal cavity.

Time frame: 3 months

Data from ClinicalTrials.gov

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