Mechanical Complication of Intrauterine Device
Conditions
Brief summary
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)
Detailed description
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.
Interventions
DRUGIUCD
IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery
Sponsors
ALshaimaa Aboalhassan Ali
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Masking description
Randomization will be based on the sequence generation created by computer and randomization tablets. Consenting patients fulfilling inclusion criteria will be randomizes into one of the following 2 groups. Randomized allocation will be kept in opaque sealed envelopes, with enrollment numbers written on the envelopes. the envelopes will contain a card on with the designated study group will be written. after enrollment of the patients in the study , the envelopes marked with study number will be unsealed and the patients allocated to either groups
Intervention model description
200 pregnant women will be included in this study, will be divided into two groups Group 1 IUCD will be inserted immediate post-placental removal and include 100 pregnant women Group2 IUCD will be inserted 6 weeks postpartum and include 100 pregnant women.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expulsion | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Displacement | 3 months | The displacement is diagnosed by doing trans-vaginal ultrasound that showed IUCD that displaced up or down word |
| Infection | 3 months | The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study. |
| Bleeding | 3 months | Irregular bleeding (including spotting, light bleeding, heavy or longer menstrual period) are common in the first 3 months and may persist. |
| Perforation | 3 months | 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. |
Countries
Egypt
Outcome results
None listed