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

Study Overview
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Brief Summary
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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
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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.

Official Title
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: Immediate Post-placental Insertion of the Intrauterine Contraceptive Device During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion

Conditions
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Mechanical Complication of Intrauterine Device

Intervention / Treatment
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* Drug: IUCD


Participation Criteria
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Eligibility Criteria
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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: Uterine anomaly that preventing replacement of IUD. Chorioamnionitis (such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C). Puerperal sepsis and unresolved postpartum hemorrhage. IUD allergy (copper). Systemic lupus erythematosus with severe thrombocytopenia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Postplacental IUCD Insertion during Cesarean section<br>IUCD inserted postplacental removal | Drug: IUCD<br>* IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery<br>|
| Active Comparator: 6 Week Post-Cesarean Insertion of IUCD<br>IUCD inserted after six weeks post Cesarean section delivery | Drug: IUCD<br>* IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Displacement | The displacement is diagnosed by doing trans-vaginal ultrasound that showed IUCD that displaced up or down word | 3 months | 
| Infection | The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study. | 3 months | 
| Bleeding | Irregular bleeding (including spotting, light bleeding, heavy or longer menstrual period) are common in the first 3 months and may persist. | 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. | 3 months |