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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postplacental IUCD Insertion during Cesarean section | Active Comparator | IUCD inserted postplacental removal |
|
| 6 Week Post-Cesarean Insertion of IUCD | Active Comparator | IUCD inserted after six weeks post Cesarean section delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IUCD | Drug | IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Yasser M Aboutalib, MD | Ain Shams University | Study Director |
| Ahmed S AbdelHamid, MD | Ain Shams University | Study Director |
| ALshaimaa A Ali, MBBch | Ain Shams University | Principal Investigator |
| Haitham Torky, MD | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Maternity Hospital | Cairo | 11311 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36302159 | Derived | Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3. |
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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.
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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
| 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 |