Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial

NCT01272960 | Completed Results

• 1 other identifier: SFP4-13
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Period

Keywords

Contraception; Postnatal care

Outcome Measures

Primary Outcomes (1)

• Mirena in Place

  Proportion of women in each arm with Mirena in place at 6 months

  6 months

Secondary Outcomes (3)

• Mirena Expulsion

  6 weeks

• Uterine Perforation

  6 months

• Intrauterine Infection

  6 months

Study Arms (2)

Interval Insertion

ACTIVE COMPARATOR

Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.

Device: Interval Insertion

Post-Placental Mirena Insertion

EXPERIMENTAL

Will receive Mirena insertion within 10 minutes of delivery of placenta

Device: Post-Placenta Mirena Insertion

Interventions

Post-Placenta Mirena Insertion DEVICE

Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Post-Placental Mirena Insertion

Interval Insertion DEVICE

Insertion of Mirena 4-8 weeks post partum after vaginal delivery

Interval Insertion

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Society of Family Planning: collaborator

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (10)

• 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.

  PMID: 16772190 BACKGROUND

• 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.

  PMID: 7409230 BACKGROUND

• 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.

  PMID: 8293847 BACKGROUND

• 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.

  PMID: 7418410 BACKGROUND

• 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.

  PMID: 4006467 BACKGROUND

• 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.

  PMID: 8631184 BACKGROUND

• 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.

  PMID: 8030457 BACKGROUND

• 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.

  PMID: 1680090 BACKGROUND

• 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.

  PMID: 17046378 BACKGROUND

• 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.

  PMID: 20966692 BACKGROUND

Limitations and Caveats

Inability to recruit and randomize our target sample size, to detect rare adverse events that may be associated with immediate insertion, women randomized to immediate insertion were more likely to return for their 6-month string check visit.

Results Point of Contact

• Title: Dr. Lorie Harper
• Organization: University of Alabama School of Medicine

lmharper@uabmc.edu

205-975-0515

Study Officials

• Lorie M Harper, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 10, 2011
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-10

Locations

US (1)