NCT02941198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

January 3, 2018

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

October 12, 2016

Last Update Submit

January 1, 2018

Conditions

Intrauterine SystemsPostpartum Immediate Contraception

Outcome Measures

Primary Outcomes (1)

  • expulsion rates

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

    The patients will be seen postoperative 6th week

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)

    The patients will be seen postoperative 6th week

Study Arms (2)

Gynefix

ACTIVE COMPARATOR

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

Cu T380a

ACTIVE COMPARATOR

conventional T-shaped IUDs (TCu380A)which has a frame will be placed into the uterus after placental extraction

Device: Cu T380 A

Interventions

GyneFixDEVICE

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

Also known as: Gynefix(frameless intrauterine devices)
Gynefix
Cu T380 ADEVICE

Cu T380 A will be inserted into the uterus

Also known as: Copper T 380a
Cu T380a

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 27631023BACKGROUND

  • 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.

    PMID: 26115018BACKGROUND

  • 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.

    PMID: 25386484BACKGROUND

  • 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.

    PMID: 21914407BACKGROUND

Study Officials

  • ceren ünal, m.d.

    medical doctor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 21, 2016

Study Start

June 1, 2016

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

January 3, 2018

Record last verified: 2017-01

Locations

TU(1)