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Sixty six women who plan to deliver a live birth singleton via cesarean delivery who desire a Copper IUD for postpartum contraception will be approached for study participation thenvwill be randomized equally into two groups using computer generated numbers.
Group (A): (n=33) women IUD insertion post placental delivery (within 10mins) Group (B): (n=33) women IUD insertion post puerperal ( 6 to 8 weeks postpartum). Primary outcome will include IUD expulsion rate in both groups. Secondary outcomes will include other complications rates: missed threads (not seen by speculum examination), displaced IUD (more than 2 cm from the fundus in ultrasound), heavy puerperal bleeding, abdominal discomfort), Pregnancy rate, Discontinuation of the IUD usage and Satisfaction rate.
Full history taking including a detailed history including medical and obstetric history, full obstetric examination and ultrasound evaluation to confirm gestational age and to exclude any of the exclusion criteria. Women who plan to deliver a live birth singleton via cesarean delivery at Kasr El-Ainy teaching will be considered for inclusion in the study. Women who desire a Copper IUD for postpartum contraception will be approached for study participation. The postpartum contraception plan will be documented during their prenatal course. It is also addressed by the obstetrical team upon admission to Labor & Delivery at El-Kasr El-Ainy teaching hospital. The obstetrical team will identify subjects who present in labor who meet the criteria and express interest in intrauterine contraception. Immediately after cesarean delivery, consented subjects will be randomized to immediate post placental IUD placement within 10 minutes or IUD placement at their routine standard postpartum visit (6 to 8 weeks postpartum).
For women randomized to the immediate post placental IUD insertion (n=33) the following will be done:
Subjects who are randomized for IUD insertion at their post puerperal visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.
For women randomized for IUD insertion at their postpartum visit (n=33) the following will be done:(n=33):
All women who are going to have their IUD placement in post puerperal visits their contact numbers will be taken.
follow-up visits at 6 weeks ,3 & 6 months post-insertion will be scheduled. At 6 weeks post-insertion visit, participants (will be assessed via ultrasound and (to detect IUD expulsion or displacement) and speculum examination ( to detect presence of IUD threads).
At 3 months post-insertion visit, all subjects will be examined. Examination will include ultrasound (to detect IUD expulsion or displacement) and speculum examination ( to detect presence of IUD threads if not detected at 6 weeks post-insertion visit).
At 6 months post-insertion visit, all subjects will be examined & answering a simple questionnaire. Examination will include ultrasound (to detect IUD expulsion or displacement) and speculum examination ( to detect presence of IUD threads if not detected at 3 months post-insertion visit). The questionnaire will include questions regarding they have had a known expulsion, pregnancy event, or elective IUD removal and about the ease of placement and overall satisfaction with the timing of placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| post placental IUD insertion | Active Comparator | Following placental delivery, uterine cavity will be examined to exclude the presence of malformations or fibroids. Uterus will be stabilized by grasping it at fundus and the copper IUD (CuT 380 IUD) will be placed (within 10 minutes following the placental delivery) through the uterine wall incision high up in the uterine fundus (either by hand or using its applicator). |
|
| post puerperal IUD insertion | Active Comparator | IUD will be inserted 6 - 8 weeks following caesarean delivery (during the post puerperal visit). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrauterine copper device | Device | The obstetrical team will identify subjects who present in labor who meet the criteria and express interest in intrauterine contraception. Immediately after cesarean delivery, consented subjects will be randomized to immediate post placental IUD placement within 10 minutes or IUD placement at their routine standard postpartum visit (6 to 8 weeks postpartum). |
| Measure | Description | Time Frame |
|---|---|---|
| IUD expulsion rate | to measure the frequency of IUD expulsion (IUD not found in ultrasound) following insertion by ultrasound examination. | 6 months (following the insertion) |
| Measure | Description | Time Frame |
|---|---|---|
| Missed threads rate (threads not seen by speculum examination) | to measure the frequency of absent threads (threads not seen by speculum examination) following insertion. | 6 months (following the insertion) |
| displaced IUD rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moutaz M Elsherbini, MD | Contact | 01001588300 | 002 | Mizosherbini@yahoo.com |
| Mirna O Awad, MSc | Contact | 01001401172 | 002 | mirnaawad91.ma@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| moutaz M ELsherbini, MD | assistant professor (faculty of medicine -Cairo University | Principal Investigator |
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| ID | Term |
|---|---|
| D007435 | Intrauterine Devices, Copper |
| ID | Term |
|---|---|
| D007436 | Intrauterine Devices, Medicated |
| D007434 | Intrauterine Devices |
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
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Randomized clinical trial
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to measure the frequency of displaced IUD (IUD more than 2 cm from the uterine fundus in ultrasound) following insertion.
| 6 months (following the insertion) |
| pregnancy rate | occurrence of any pregnancy event | within the 1st 6 months after insertion |
| satisfaction rate | by using questionnaire that include questions regarding they have had a known expulsion, pregnancy event, or elective IUD removal and about the ease of placement and overall satisfaction with the timing of placement. | 6 months after insertion |
| D004864 | Equipment and Supplies |