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

Z

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status

Completed

Conditions

Postpartum Immediate Contraception
Intrauterine Systems

Treatments

Device: GyneFix
Device: Cu T380 A

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

140 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Gynefix
Active Comparator group
Description:
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
Treatment:
Device: GyneFix
Cu T380a
Active Comparator group
Description:
conventional T-shaped IUDs (TCu380A)which has a frame will be placed into the uterus after placental extraction
Treatment:
Device: Cu T380 A

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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