Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial

Postpartum Period Clinical Trial

— MISTIC  

Official title:

Randomized, Open-label, Controlled Trial of Immediate Postpartum Versus Interval Insertion of Mirena to Increase the Usage at 6 Months After Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272960
• Other study ID #: SFP4-13
• Status: Completed
• Phase: N/A
• First received: January 6, 2011
• Last updated: October 24, 2017
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized to receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms experienced by participants. This is a sub-study of the Contraceptive Choice Project, a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers which has already enrolled over 5,000 patients. Association of this study with CHOICE offers unique advantages including infrastructure to support subject recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS devices.

We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS immediately after placenta delivery will have higher rates of LNG-IUS continuation due to poor rates of follow up in the interval insertion group. This is likely to be particularly noticeable in our patient population, which is largely uninsured with poor access to healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping, which may be disguised by the post-partum period. Published reports of immediate post-placenta insertion focus on expulsion rates and do not report on symptoms and satisfaction rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

• 14-45 years

• Vaginal Delivery at Barnes-Jewish Hospital

• Sexually active with male partner

• No tubal ligation/hysterectomy

• Not currently using contraception

• Desire reversible contraception

• Reside in St. Louis City/County

• Requests Mirena(R) intrauterine device for contraception

Exclusion Criteria:

• Allergy to Mirena(R) system

• Cesarean delivery

• Cervical cancer, breast cancer

• Active liver disease

• Untreated cervicitis

• Uterine anomaly/fibroids preventing Mirena(R) placement

• Delivery <36 weeks

• Chorioamnionitis

• Prolonged rupture of membranes (>18 hours)

Related Conditions & MeSH terms

• Postpartum Period

Intervention

Device:
• Post-Placenta Mirena Insertion
Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta
• Interval Insertion
Insertion of Mirena 4-8 weeks post partum after vaginal delivery

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (10)

Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac. — View Citation

Comparative multicentre trial of three IUDs inserted immediately following delivery of the placenta. Contraception. 1980 Jul;22(1):9-18. — View Citation

Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. Epub 2006 Sep 15. — View Citation

Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006 Jun;38(2):90-6. — View Citation

Gillett PG, Lee NH, Yuzpe AA, Cerskus I. A comparison of the efficacy and acceptability of the Copper-7 intrauterine device following immediate or delayed insertion after first-trimester therapeutic abortion. Fertil Steril. 1980 Aug;34(2):121-4. — View Citation

Morrison C, Waszak C, Katz K, Diabaté F, Mate EM. Clinical outcomes of two early postpartum IUD insertion programs in Africa. Contraception. 1996 Jan;53(1):17-21. — View Citation

Sivin I, Stern J. Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive devices: a multicenter study. International Committee for Contraception Research (ICCR). Fertil Steril. 1994 Jan;61(1):70-7. — View Citation

Thiery M, Van Kets H, Van der Pas H. Immediate post-placental IUD insertion: the expulsion problem. Contraception. 1985 Apr;31(4):331-49. — View Citation

Xu JX, Reusché C, Burdan A. Immediate postplacental insertion of the intrauterine device: a review of Chinese and the world's experiences. Adv Contracept. 1994 Mar;10(1):71-82. Review. — View Citation

Zhou SW, Chi IC. Immediate postpartum IUD insertions in a Chinese hospital--a two year follow-up. Int J Gynaecol Obstet. 1991 Jun;35(2):157-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mirena in Place	Proportion of women in each arm with Mirena in place at 6 months	6 months
Secondary	Mirena Expulsion	The percentage of patients with post-placental placement of Mirena who experience an expulsion	6 weeks
Secondary	Uterine Perforation	The proportion of patients in each arm who experience a uterine perforation	6 months
Secondary	Intrauterine Infection	The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)	6 months