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To compare two intrauterine systems in order to avoid complications originating from short pregnancy interval and undesired pregnancies in the early postpartum period.
The patients admitting to Zeynep Kamil Research and Training Hospital for caesarean delivery will be included in the study. There will be two computer based randomized groups. The investigators expect that both groups will have 100 cases. First group will be treated with conventional intrauterine devices (Cu T380 A) while the second group will be treated with frameless intrauterine devices (GyneFix). The participants will be informed about postpartum unplanned pregnancies and the complications of short pregnancy interval. Participants will also be informed about possible complications of having an intrauterine device and that there may be a possibility of failure.The participants who choose to participate in the study will be divided into two groups by computer based randomization and one of the systems will be applied. After the participants read and sign the informed consent form, the intrauterine device will be applied postplacental up to 10 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gynefix | Active Comparator | The GyneFix® 200 IUD(frameless iud) is only 2 cm long. Its small surface area is 1/3 of that of the conventional T-shaped IUDs such as TCu380A |
|
| Cu T380a | Active Comparator | conventional T-shaped IUDs (TCu380A)which has a frame will be placed into the uterus after placental extraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GyneFix | Device | The fiber is fixed to the anchoring thread by means of a stainless steel clip 1 cm from the upper part of the anchoring knot. The anchoring knot is implanted into the myometrium of the uterus thus permanently securing the implant in the uterine cavity |
| Measure | Description | Time Frame |
|---|---|---|
| expulsion rates | expulsion is the major obstacle for intrauterin devices when using immediate postpartum. | The patients will be seen postoperative 6th week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by conventional intrauterine devices (Cu T380 A) and frameless intrauterine devices (GyneFix) | there are some effects due to intrauterin devices. we want to compare the differences between two devices | The patients will be seen postoperative 6th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ceren ünal, m.d. | medical doctor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology | Istanbul | 34000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27631023 | Background | Hooda R, Mann S, Nanda S, Gupta A, More H, Bhutani J. Immediate Postpartum Intrauterine Contraceptive Device Insertions in Caesarean and Vaginal Deliveries: A Comparative Study of Follow-Up Outcomes. Int J Reprod Med. 2016;2016:7695847. doi: 10.1155/2016/7695847. Epub 2016 Aug 17. | |
| 26115018 | Background | Lopez LM, Bernholc A, Hubacher D, Stuart G, Van Vliet HA. Immediate postpartum insertion of intrauterine device for contraception. Cochrane Database Syst Rev. 2015 Jun 26;2015(6):CD003036. doi: 10.1002/14651858.CD003036.pub3. |
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| Cu T380 A | Device | Cu T380 A will be inserted into the uterus |
|
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| 25386484 | Background | Singal S, Bharti R, Dewan R, Divya, Dabral A, Batra A, Sharma M, Mittal P. Clinical Outcome of Postplacental Copper T 380A Insertion in Women Delivering by Caesarean Section. J Clin Diagn Res. 2014 Sep;8(9):OC01-4. doi: 10.7860/JCDR/2014/10274.4786. Epub 2014 Sep 20. |
| 21914407 | Background | Bhutta SZ, Butt IJ, Bano K. Insertion of intrauterine contraceptive device at caesarean section. J Coll Physicians Surg Pak. 2011 Sep;21(9):527-30. |