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| Name | Class |
|---|---|
| Mulago Hospital, Uganda | OTHER |
| Brigham and Women's Hospital | OTHER |
| Society of Family Planning | OTHER |
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The purpose of this study is to determine, in a pilot setting, if this study is feasible in terms of recruitment, willingness to be randomized, provision of contraceptive methods, and follow-up. The investigators hypothesize that this pilot study will be feasible in terms of recruitment, provision of care, and follow-up.
The study will be a pilot randomized controlled trial comparing outcomes of immediate post-placental insertion of the Copper T 380A (Group 1) to outcomes of interval insertion of the Copper T 380A performed 6 weeks after delivery (Group 2) for patients undergoing scheduled cesarean delivery at Mulago Hospital in Kampala, Uganda. This study will not be powered to detect a difference, but rather the investigators will enroll all eligible and interested women during the three-month enrollment period. Potential participants who do not choose an IUD or who choose not to participate will be offered an anonymous opt-out survey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 weeks interval insertion | Other | IUD is inserted 6 weeks following c-section delivery of baby and placenta |
|
| Immediate insertion | Experimental | IUD is inserted immediately following c-section delivery of baby and placenta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate insertion | Other | Insertion of Copper T 380A immediately after c-section delivery of baby and placenta |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 month IUD usage rates | The number of participants enrolled who are using the Copper T 380A at 6 months post-delivery. This will include participants who are excluded at time of delivery or interval insertion and participants who do not follow up for interval Copper T 380A insertion | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| IUD Expulsion | The time until expulsion of the Copper T 380A 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 Copper T 380A 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 |
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Inclusion Criteria:
Exclusion Criteria:
Post enrollment exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | Planned Parenthood League of Massachusetts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago Hospital | Kampala | Uganda |
| 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. | |
| 25499587 | Derived | Lester F, Kakaire O, Byamugisha J, Averbach S, Fortin J, Maurer R, Goldberg A. Intracesarean insertion of the Copper T380A versus 6 weeks postcesarean: a randomized clinical trial. Contraception. 2015 Mar;91(3):198-203. doi: 10.1016/j.contraception.2014.12.002. Epub 2014 Dec 12. |
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| 6 weeks interval insertion | Other | Insertion of Copper T 380A 6 weeks after c-section delivery of baby and placenta |
|
| within 6 months |
| IUD Removal | The proportion of participants who have the Copper T 380A inserted and who deliberately have it removed. We will also analyze the time to removal for these participants | within six months |
| IUD insertion | The proportion of participants receiving a Copper T 380A in each group | within 6 months |
| Pregnancy | Time to pregnancy will be calculated from the date of delivery until the estimated date of conception of a subsequent pregnancy, as based on sonographic dating. If sonographic dating is not available, the date of the last missed menses or three weeks before the first positive urine pregnancy test (if amenorrheic or oligomenorrheic) will be used | within 6 months |
| Infection | The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study | within 6 months |
| Uterine Perforation | The diagnosis of a perforation may be made by a transvaginal sonogram that shows no Copper T 380A within the uterus and an abdominal radiograph that shows a Copper T 380A within the abdominal cavity | within 6 months |