Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial (MISTIC)

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Period
• Intervention / Treatment: Device: Interval Insertion; Device: Post-Placenta Mirena Insertion

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interval Insertion; Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.	Device: Interval Insertion; Insertion of Mirena 4-8 weeks post partum after vaginal delivery
Experimental: Post-Placental Mirena Insertion; Will receive Mirena insertion within 10 minutes of delivery of placenta	Device: Post-Placenta Mirena Insertion; Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mirena in Place	Proportion of women in each arm with Mirena in place at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mirena Expulsion	The percentage of patients with post-placental placement of Mirena who experience an expulsion	6 weeks
Uterine Perforation	The proportion of patients in each arm who experience a uterine perforation	6 months
Intrauterine Infection	The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)	6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Lorie M Harper, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1363/psrh.38.090.06.
• 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. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.
• Comparative multicentre trial of three IUDs inserted immediately following delivery of the placenta. Contraception. 1980 Jul;22(1):9-18. doi: 10.1016/0010-7824(80)90112-2.
• Morrison C, Waszak C, Katz K, Diabate F, Mate EM. Clinical outcomes of two early postpartum IUD insertion programs in Africa. Contraception. 1996 Jan;53(1):17-21. doi: 10.1016/0010-7824(95)00254-5.
• 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. doi: 10.1016/s0015-0282(16)56455-3.
• 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. doi: 10.1016/s0015-0282(16)44893-4. No abstract available.
• Thiery M, Van Kets H, Van der Pas H. Immediate post-placental IUD insertion: the expulsion problem. Contraception. 1985 Apr;31(4):331-49. doi: 10.1016/0010-7824(85)90002-2.
• Xu JX, Reusche 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. doi: 10.1007/BF01986532.
• 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. doi: 10.1016/0020-7292(91)90820-u.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 6, 2011
• First Submitted That Met QC Criteria: January 7, 2011
• First Posted (Estimate): January 10, 2011

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Contraception; Postnatal care
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: SFP4-13