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Trial registered on ANZCTR


Registration number
ACTRN12617000509369p
Ethics application status
Submitted, not yet approved
Date submitted
29/03/2017
Date registered
7/04/2017
Date last updated
10/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Uptake of levonorgestrel releasing intrauterine system (LNG-IUS, Mirena 'Registered Trademark') at caesarean section
Scientific title
A study of uptake rate of levonorgestrel releasing system intrauterine system (LNG-IUS) at elective caesarean section
Secondary ID [1] 291529 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fertility 302619 0
caesarean section 302706 0
Condition category
Condition code
Reproductive Health and Childbirth 302142 302142 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Levonorgestrel releasing intrauterine system (LNG-IUS, Mirena 'Registered Trademark") is an intrauterine device that provides contraception for up to five years. It releases levonorgestrel over 5 years, at an initial dose of 20ug over 24 hours. It is usually inserted at least six weeks after delivery. Recent Australian contraception guidelines support its insertion at the time of caesarean section. This study is to investigate how many women choose to have LNG-IUS inserted at caesarean section when it is offered, as well as looking at the reasons that women choose to have the device inserted.
Women who are planning to have an elective caesarean section will have one or more consultations with a doctor to arrange and consent to caesarean section. The treating doctor will discuss LNG-IUS insertion at the time of caesarean, and will provide the women with written information about this.
The women will be asked to consent to answer a few questions about their experience with and attitude to LNG-IUS regardless of whether they choose to have the LNG-IUS inserted at the time of caesarean section.
The device is designed to remain in place for five years, but can be removed earlier if the woman wishes.
Women who have LNG-IUS inserted at the time of caesarean section will be followed up six weeks and one year after delivery.
Intervention code [1] 297598 0
Treatment: Drugs
Intervention code [2] 297689 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301571 0
The primary outcome is whether women choose to have the LNG-IUS inserted at the time of caesarean section.
The women state their choice directly to the doctor arranging the caesarean section, and recorded in the medical record
Timepoint [1] 301571 0
Prior to caesarean section
Secondary outcome [1] 333084 0
LNG-IUS expulsion
Timepoint [1] 333084 0
Assessed by ultrasound at 6 weeks after delivery
Assessed by phone call to patient at 1 year after delivery
Secondary outcome [2] 333085 0
Strings visible in vagina
Timepoint [2] 333085 0
Assessed by speculum examination at 6 weeks postnatal checkup
Secondary outcome [3] 333086 0
patient satisfaction
Timepoint [3] 333086 0
Assessed on 5-point Likert Scale 6 weeks and 1 year after LNG-IUS inserted
Secondary outcome [4] 333087 0
vaginal bleeding pattern using a simple questionnaire designed for this study

Timepoint [4] 333087 0
Assessed by patient questionnaire 6 weeks and 1 year after LNG-IUS insertion
Secondary outcome [5] 333088 0
continuing LNG-IUS use
Timepoint [5] 333088 0
Assessed by phone call to woman 1 year after LNG-IUS insertion

Eligibility
Key inclusion criteria
Women who are planning an elective caesarean section will be eligible for the study of the primary outcome, which is whether or not they choose to have immediate insertion of LNG-IUS at the time of surgery.




Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy to LNG-IUS
Prolonged rupture of membranes
Suspected chorioamnionitis or pelvic infection
Uterine anomaly (bicornuate or septate uterus)
Abnormal cervical cytology requiring follow-up
Planning to have another pregnancy within 12 months
Unable to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not relevant
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study is examining women's choice of contraception, therefore there will be no allocation, blinding or assignment
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to analyse the uptake rate of LNG-IUS at caesarean as well as secondary outcomes. A multivariate model using binomial regression will be used to analyse factors predicting uptake of LNG-IUS at caesarean.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
HREC approval not received
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7727 0
Mackay Base Hospital - Mackay
Recruitment hospital [2] 7728 0
Proserpine Hospital - Proserpine
Recruitment postcode(s) [1] 15651 0
4740 - Mackay
Recruitment postcode(s) [2] 15652 0
4800 - Proserpine

Funding & Sponsors
Funding source category [1] 296016 0
Other Collaborative groups
Name [1] 296016 0
Mackay Institute of Research and Innovation
Address [1] 296016 0
Mackay Base Hospital
Bridge Road
Mackay
Qld
4740
Country [1] 296016 0
Australia
Primary sponsor type
Hospital
Name
Mackay Hospital and Health Service
Address
Mackay Base Hospital
Bridge Road
Mackay
Qld
4740
Country
Australia
Secondary sponsor category [1] 294906 0
None
Name [1] 294906 0
Address [1] 294906 0
Country [1] 294906 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297278 0
Townsville Human Research Ethics Committee
Ethics committee address [1] 297278 0
Level 1
JCU Clinical School
The Townsville Hospital
100 Angus Smith Drive
Townsville
QLD
4814
Ethics committee country [1] 297278 0
Australia
Date submitted for ethics approval [1] 297278 0
27/03/2017
Approval date [1] 297278 0
Ethics approval number [1] 297278 0

Summary
Brief summary
Initiating long acting reversible contraception at the time of delivery has several advantages that include high patient motivation, convenience, access to trained professionals, no need for an outpatient insertion (which may be uncomfortable)
and immediate contraception prior to the resumption of ovulation(1, 2) . Levonorgestrel releasing intrauterine system (LNGIUS, Mirena, Bayer Healthcare), is an intrauterine long acting reversible contraceptive that provides contraception for 5 years(3). In Australia its use almost always involves insertion through the vagina 6 weeks or more after childbirth (standard insertion). The 2016 Australian contraception guidelines rate immediate insertion of LNGIUS at delivery including caesarean section as category 1 (that is no restrictions placed on use) (4). Mwalwanda and Black (2013) note that, “No studies have specifically examined the uptake rate, long term continuation rates, acceptability or effectiveness” (of LNG-IUS in the immediate postpartum period) (2).

Intrauterine device (IUD) insertion has low rates of adverse events such as pain and infection, regardless of timing or route of insertion(1, 5).

Expulsion rates following device insertion at the time of caesarean may be higher than following standard insertion but more research is required to quantify the risk. Expulsion of IUDs including LNG-IUS following standard insertion is reported to occur in approximately 1 in 20 women(2). Three studies have been examined expulsion rates of LNG-IUS inserted at caesarean section. Expulsion rates were 0%(6, 7) and 20% (8).

IUDs including LNGIUS have nylon strings attached. The strings are useful because they can be seen or felt to check that the device is still present, and they can be pulled to remove the device when this is desired. When devices are inserted through the vagina into the uterus the strings are always visible in the vagina initially, and the chance of strings not being visible in the cervix at follow up visits is 5%(9). When IUDs are inserted at caesarean section the chance of the strings not being in the vagina at followup is 8%(10).

Patient satisfaction with LNG-IUS insertion at caesarean section has been found to be high, and not different to standard insertion(7).

Continued use of LNGIUS inserted at caesarean for 12 months after delivery has been found to be higher than following standard insertion but this difference was not statistically significant (60.0% vs 40.9%, p=0.35)(8).

LNG-IUS contains the hormone levonorgestrel, which is a progestogen. Studies of use of various types of progestogen containing contraceptives early in the neonatal period have not show a consistent adverse effect on breastfeeding initiation or continuation, or on neonatal outcomes such as growth and development(11).

LNGIUS insertion at the time of caesarean section is associated with reduced postpartum bleeding compared with insertion of copper-containing IUD at caesarean section or no device insertion at caesarean section(12).

There is some evidence that the theoretical advantages of LNGIUS insertion at caesarean encourage higher patient uptake. Two studies of immediate LNGIUS insertion at the time of caesarean section compared to standard insertion showed that more women had the procedure done in the immediate insertion group (19/20 vs 18/22)(8) and 25/25 vs 19/23(7) .

This trial aims to offer LNGIUS insertion at elective caesarean section. Uptake rate is the primary endpoint. Device expulsion, string visibility, patient satisfaction, continuing use and bleeding pattern will also be recorded.


REFERENCES
1. Lopez LM. Immediate postpartum insertion of intrauterine device for contraception. Cochrane Database of Systematic Reviews [Internet]. 2015; (6). Available from: http://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,athens&db=edschh&AN=edschh.CD003036&site=eds-live.
2. Mwalwanda C, Black K. Immediate post-partum initiation of intrauterine contraception and implants: a review of the safety and guidelines for use. The Australian & New Zealand Journal Of Obstetrics & Gynaecology. 2013;53(4):331-7.
3. Heinemann K, Reed S, Moehner S, Do Minh T. Original research article: Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices. Contraception. 2015;91:280-3.
4. Family Planning New South Wales FPV, True Relationships and Reproductive Health. Contraception: An Australian Clinical Practice Handbook. Fourth Edition ed. Australia: Family Planning NSW,Family Planning Victoria and True Relationships and Reproductive Health; 2016.
5. Kapp N, Curtis K. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009;80(4):327-36.
6. Puzey M. Mirena at caesarean section. The European Journal Of Contraception & Reproductive Health Care: The Official Journal Of The European Society Of Contraception. 2005;10(3):164-7.
7. Braniff K, Gomez E, Muller R. A randomised clinical trial to assess satisfaction with the levonorgestrel- releasing intrauterine system inserted at caesarean section compared to postpartum placement. The Australian & New Zealand Journal Of Obstetrics & Gynaecology. 2015;55(3):279-83.
8. Whitaker AK, Endres LK, Mistretta SQ, Gilliam ML. Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial. Contraception. 2014;89(6):534-9.
9. Marchi N, Castro S, Hidalgo M, Hidalgo C, Monteiro-Dantas C, Villarroeal M, et al. Management of missing strings in users of intrauterine contraceptives. Contraception. 2012;86(4):354-8.
10. Bhutta S, Butt I, Bano K. Insertion of intrauterine contraceptive device at caesarean section. Journal Of The College Of Physicians And Surgeons Pakistan. 2011;21(9):527-30.
11. FSRH. Clinical Effectiveness Unit Guidance Intrauterine Contraception April 2015 2015 [updated October 2015]. Available from: https://www.fsrh.org/documents/ceuguidanceintrauterinecontraception/.
12. Elsedeek M. Puerperal and menstrual bleeding patterns with different types of contraceptive device fitted during elective cesarean delivery. International Journal Of Gynaecology And Obstetrics. 2012;116(1):31-4.

Trial website
No trial website
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 73558 0
Dr Kathleen Braniff
Address 73558 0
Department of Obstetrics and Gynaecology
Mackay Base Hospital
Bridge Road
Mackay
QLD
4740
Country 73558 0
Australia
Phone 73558 0
+61 748857216
Fax 73558 0
+61 748857989
Email 73558 0
kathleen.braniff@health.qld.gov.au
Contact person for public queries
Name 73559 0
Dr Kathleen Braniff
Address 73559 0
Department of Obstetrics and Gynaecology
Mackay Base Hospital
Bridge Road
Mackay
QLD
4740
Country 73559 0
Australia
Phone 73559 0
+61 748857216
Fax 73559 0
+61 748857989
Email 73559 0
kathleen.braniff@health.qld.gov.au
Contact person for scientific queries
Name 73560 0
Dr Kathleen Braniff
Address 73560 0
Department of Obstetrics and Gynaecology
Mackay Base Hospital
Bridge Road
Mackay
QLD
4740
Country 73560 0
Australia
Phone 73560 0
+61 748857216
Fax 73560 0
+61 748857989
Email 73560 0
kathleen.braniff@health.qld.gov.au

No data has been provided for results reporting
Summary results
Not applicable