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

Comparative of Two Devices (Conventional Intrauterine Devices (Cu T380 A)/Frameless Intrauterine Devices (GyneFix)) for Postpartum Immediate Contraception in Cesarean Deliveries

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

Study Overview

• Status: Completed
• Conditions: Intrauterine Systems; Postpartum Immediate Contraception
• Intervention / Treatment: Device: GyneFix; Device: Cu T380 A

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gynefix; 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	Device: GyneFix; 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; Other Names: Gynefix(frameless intrauterine devices)
Active Comparator: Cu T380a; conventional T-shaped IUDs (TCu380A)which has a frame will be placed into the uterus after placental extraction	Device: Cu T380 A; Cu T380 A will be inserted into the uterus; Other Names: Copper T 380a

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Investigators: Principal Investigator: ceren ünal, m.d., Medical doctor

Publications and helpful links

General Publications

• 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.
• 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;(6):CD003036. doi: 10.1002/14651858.CD003036.pub3.
• 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.
• 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. Erratum In: J Coll Physicians Surg Pak. 2011 Nov;21(11):717.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 1, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Copper
• Other Study ID Numbers: 110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided