Clinical trial NCT02941198: Postpartum Immediate Contraception in Cesarean Deliveries-Comparison of Two Intrauterine Systems
Official title: Comparative of Two Devices (Conventional Intrauterine Devices (Cu T380 A)/Frameless Intrauterine Devices (GyneFix)) for Postpartum Immediate Contraception in Cesarean Deliveries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Systems
Postpartum Immediate Contraception
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare two intrauterine systems in order to avoid complications originating from short pregnancy interval and undesired pregnancies in the early postpartum period.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The patients who read and sign the informed consent form.

Exclusion Criteria:

* The patient who has more than 6 cm dilatation, prolonged premature rupture of the membranes (more than 12 hours), chorioamnionitis, and kongenital or acquired haemorragic diathesis will be excluded from the study.

Primary outcomes:
measure: expulsion rates
timeFrame: The patients will be seen postoperative 6th week
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by conventional intrauterine devices (Cu T380 A) and frameless intrauterine devices (GyneFix)
timeFrame: The patients will be seen postoperative 6th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology
Study officials:
affiliation: medical doctor
name: ceren ünal, m.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.