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

• ClinicalTrials.gov Identifier: NCT01272960
• Recruitment Status: Completed
• First Posted: January 10, 2011
• Results First Posted: December 2, 2017
• Last Update Posted: December 2, 2017
• Sponsor: Washington University School of Medicine
• Collaborator: Society of Family Planning
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Postpartum Period	Device: Post-Placenta Mirena Insertion; Device: Interval Insertion	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized, Open-label, Controlled Trial of Immediate Postpartum Versus Interval Insertion of Mirena to Increase the Usage at 6 Months After Delivery
• Study Start Date: October 2010
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Mirena in Place [ Time Frame: 6 months ]
   Proportion of women in each arm with Mirena in place at 6 months

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, Missouri

Barnes Jewish Hospital

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Society of Family Planning

Investigators

• Principal Investigator: Lorie M Harper, MD; Washington University School of Medicine

More Information

Publications:

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.

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.

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.

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

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

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.

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.

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.

Eroğlu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taşkin 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.

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.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01272960
• Other Study ID Numbers: SFP4-13
• First Posted: January 10, 2011
• Results First Posted: December 2, 2017
• Last Update Posted: December 2, 2017
• Last Verified: October 2017

Keywords provided by Washington University School of Medicine:

Contraception; Postnatal care

Additional relevant MeSH terms:

Levonorgestrel; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral