Postpartum Immediate Contraception in Cesarean Deliveries-Comparison of Two Intrauterine Systems

Not Applicable

Completed

• Conditions: Intrauterine Systems; Postpartum Immediate Contraception

• Registration Number: NCT02941198
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Status Verified: 2017-01
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Last Update Submitted: 2018-01-01
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
expulsion rates	The patients will be seen postoperative 6th week	expulsion is the major obstacle for intrauterin devices when using immediate postpartum.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by conventional intrauterine devices (Cu T380 A) and frameless intrauterine devices (GyneFix)	The patients will be seen postoperative 6th week	there are some effects due to intrauterin devices. we want to compare the differences between two devices

Trial Locations

Locations (1)

Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology; 🇹🇷 Istanbul, Turkey