Intrauterine SystemsNCT02941198
Postpartum Immediate Contraception in Cesarean Deliveries-Comparison of Two Intrauterine Systems
A study testing GyneFix and Cu T380 A in people with Intrauterine Systems and Postpartum Immediate Contraception, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare two intrauterine systems in order to avoid complications originating from short pregnancy interval and undesired pregnancies in the early postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Systems, Postpartum Immediate Contraception
- What is being tested?
- GyneFix and Cu T380 A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2016to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patients who read and sign the informed consent form.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology
Istanbul, 34000
About this study
Official title: 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.
Read the 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.
- Being tested
- GyneFix, Cu T380 A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GyneFixDevice
Also called Gynefix(frameless intrauterine devices)
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
Cu T380 ADevice
Also called Copper T 380a
Cu T380 A will be inserted into the uterus
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: GyneFix |
| Cu T380a | Active comparator | conventional T-shaped IUDs (TCu380A)which has a frame will be placed into the uterus after placental extraction Receives: Device: Cu T380 A |
What is being measured
The primary outcome is the main question the study is designed to answer.
expulsion rates
expulsion is the major obstacle for intrauterin devices when using immediate postpartum.
Measured: 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)
there are some effects due to intrauterin devices. we want to compare the differences between two devices
Measured: The patients will be seen postoperative 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 Jun 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intrauterine SystemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- ceren ünal, m.d., Principal investigator, medical doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941198
- Sponsor's protocol ID
- 110
- Status last verified
- Jan 2017
- First submitted
- 12 Oct 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 27631023Lopez 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.
PubMed 26115018Singal 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.
PubMed 25386484Bhutta SZ, Butt IJ, Bano K. Insertion of intrauterine contraceptive device at caesarean section. J Coll Physicians Surg Pak. 2011 Sep;21(9):527-30.
PubMed 21914407
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative of Two Devices (Conventional Intrauterine Devices (Cu T380 A)/Frameless Intrauterine Devices (GyneFix)) for Postpartum Immediate Contraception in Cesarean Deliveries
- ClinicalTrials.gov ID
- NCT02941198
- Acronym / sponsor ID
- 110
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gynefix | Active comparator | Device: GyneFixThe 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 |
| Cu T380a | Active comparator | Device: Cu T380 Aconventional T-shaped IUDs (TCu380A)which has a frame will be placed into the uterus after placental extraction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patients who read and sign the informed consent form.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GyneFixAlso: Gynefix(frameless intrauterine devices)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 | Device | Gynefix |
| Cu T380 AAlso: Copper T 380aCu T380 A will be inserted into the uterus | Device | Cu T380a |
Primary outcome
expulsion rates
Time frame: The patients will be seen postoperative 6th week
expulsion is the major obstacle for intrauterin devices when using immediate postpartum.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Background: PubMed 27631023Hooda 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.
- Background: PubMed 26115018Lopez 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.
- Background: PubMed 25386484Singal 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.
- Background: PubMed 21914407Bhutta SZ, Butt IJ, Bano K. Insertion of intrauterine contraceptive device at caesarean section. J Coll Physicians Surg Pak. 2011 Sep;21(9):527-30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ceren ünal, m.d. principal investigator
medical doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GyneFix and Cu T380 A in people with Intrauterine Systems and Postpartum Immediate Contraception, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expulsion rates (time frame: The patients will be seen postoperative 6th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02941198, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.