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Completed

NCT Number: NCT02941198

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

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

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Key information

Conditions

Intrauterine Systems Postpartum Immediate Contraception

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Gynefix(frameless intrauterine devices)

Cu T380 A

Device

Cu T380 A will be inserted into the uterus

Other names: Copper T 380a

Primary outcomes

  1. expulsion rates

    Time frame: The patients will be seen postoperative 6th week

    expulsion is the major obstacle for intrauterin devices when using immediate postpartum.

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by conventional intrauterine devices (Cu T380 A) and frameless intrauterine devices (GyneFix)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2016
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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