Postpartum Intrauterine Device Study

Study Overview
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Brief Summary
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The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit. The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.

Detailed Description
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Women will be enrolled into the study during prenatal care. After delivery, if they meet secondary eligibility criteria, they will be randomized to receive the IUD immediately postpartum or at the 6-week postpartum visit. Women will be followed at 4, 8, and 12 weeks after IUD insertion, and be assessed at those time points for satisfaction with the method and IUD expulsion.

Official Title
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A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi

Conditions
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Contraception, Intrauterine Devices, Pilot Study, Africa

Intervention / Treatment
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* Device: Copper T380A Intrauterine Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Inclusion Criteria: Ages 18-45 attending prenatal care Greater than 34 weeks estimated gestational age Desire to use the CuT380A-IUCD for contraception postpartum Plan to stay in the area for at least 5 months postpartum If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport No prior cesarean delivery No treatment for pelvic inflammatory disease within 3 months prior to pregnancy No known uterine anomalies No known pelvic tuberculosis No known genital tract cancer No known allergy to copper No known history of ectopic pregnancy within 3 months prior to pregnancy. No evidence of clinical anemia as assessed by a clinician at enrollment Any other condition a clinician feels should preclude the woman from receiving the IUCD 10-minutes to 48 hours after delivery Secondary Eligibility Criteria Vaginal delivery within the last 48 hours No postpartum hemorrhage documented by the delivering clinician Not known to have ruptured membranes for greater than 24 hours prior to delivery No infection diagnosed by a clinician No fever of greater than 38° during labour or delivery Any other condition which a clinician feels precludes the woman from receiving the IUCD 10 minutes to 48 hours after delivery. Exclusion Criteria: prior cesarean section fever during labor and delivery AIDS, not well on antiretroviral therapy genital tuberculosis known uterine abnormalities or genital tract cancer history of ectopic pregnancy within 3 months of current pregnancy

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate postpartum IUD insertion<br>Women assigned to have the IUD placed 10 minutes to 48 hours postpartum | Device: Copper T380A Intrauterine Device<br>* the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.<br>|
| Experimental: 6 week postpartum IUD insertion<br>Women who receive the IUD at the traditional time frame. | Device: Copper T380A Intrauterine Device<br>* the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | Estimate the time required to enroll 140 women into this study | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion rates | Estimate the expulsion rate of the CuT380A-IUCD | 6 months | 
| Satisfaction | Assess patient and provider satisfaction when the CuT380A-IUCD is placed 10 minutes - 48-hours postpartum. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Contraception, Intrauterine device, feasibility, IUD, Immediate postpartum IUD