Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
Study Details
Study Description
Brief Summary
The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization?
The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the investigators will document the natural history of the location of the IUD within the uterus when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks, and 3 months postpartum, to better understand the relationship between position of the IUD and subsequent expulsion.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Mirena Group Women who have a postplacental Mirena IUD placed. (LNG-IUS) |
Drug: Mirena
The IUD will be placed as part of standard clinical care.
Other Names:
|
Paragard Group Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) |
Device: Paragard
The IUD will be placed as part of standard clinical care.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- IUD Expulsion Rate [3 months postpartum]
The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.
Secondary Outcome Measures
- Pregnancy [6 weeks]
A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.
- Pregnancy [3 months]
A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.
- Complications [3 months]
A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported.
- Satisfaction [3 months]
A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of >= 8 are reported by percent of participants.
- Intrauterine Device Expulsion (Day 1) [Day 1]
Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.
- Intrauterine Device Expulsion (6 Weeks) [6 weeks]
Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound.
- Intrauterine Device Expulsion by 12 Weeks Postpartum [12 weeks]
Position of the IUD within the uterus will be documented by ultrasound.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women age ≥ 18
-
Desire for immediate postpartum IUD or postpartum day #1 after a postplacental IUD placement
-
English or Spanish speaking
-
Willing to attend 2 follow-up visits
Exclusion Criteria:
-
Multiple gestations
-
Delivery prior to 35 weeks gestational age
-
Allergy or sensitivity to any component of either IUD (including polyethylene, levonorgestrel or copper)
-
Cesarean delivery
-
Postpartum hemorrhage (estimated blood loss > 500 mL)
-
Chorioamnionitis
-
Abnormal uterine anatomy (including uterine anomaly or large fibroids)
-
Treated for Chlamydia or Gonorrhea during pregnancy without a subsequent negative follow-up test
-
Current cervical cancer or carcinoma in situ
-
Current breast cancer
-
Wilson's disease
-
If enrolling postpartum after IUD has already been placed, women will be excluded if the provider used an insertion technique other than using the ring forceps or the operator's hand
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Colorado Denver | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- Society of Family Planning
Investigators
- Principal Investigator: Stephanie Teal, MD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
- ACOG Practice Bulletin No. 121: Long-acting reversible contraception: Implants and intrauterine devices. Obstet Gynecol. 2011 Jul;118(1):184-196. doi: 10.1097/AOG.0b013e318227f05e.
- Allen RH, Goldberg AB, Grimes DA. Expanding access to intrauterine contraception. Am J Obstet Gynecol. 2009 Nov;201(5):456.e1-5. doi: 10.1016/j.ajog.2009.04.027. Epub 2009 Jun 13.
- Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception. 1994 Jan;49(1):56-72.
- Braaten KP, Benson CB, Maurer R, Goldberg AB. Malpositioned intrauterine contraceptive devices: risk factors, outcomes, and future pregnancies. Obstet Gynecol. 2011 Nov;118(5):1014-1020. doi: 10.1097/AOG.0b013e3182316308.
- Celen S, Möröy P, Sucak A, Aktulay A, Danişman N. Clinical outcomes of early postplacental insertion of intrauterine contraceptive devices. Contraception. 2004 Apr;69(4):279-82.
- Centers for Disease Control and Prevention (CDC). Update to CDC's U.S. Medical Eligibility Criteria for Contraceptive Use, 2010: revised recommendations for the use of contraceptive methods during the postpartum period. MMWR Morb Mortal Wkly Rep. 2011 Jul 8;60(26):878-83.
- 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.
- Chi IC, Wilkens L, Rogers S. Expulsions in immediate postpartum insertions of Lippes Loop D and Copper T IUDs and their counterpart Delta devices--an epidemiological analysis. Contraception. 1985 Aug;32(2):119-34.
- Comparative multicentre trial of three IUDs inserted immediately following delivery of the placenta. Contraception. 1980 Jul;22(1):9-18.
- Conde-Agudelo A, Rosas-Bermúdez A, Kafury-Goeta AC. Birth spacing and risk of adverse perinatal outcomes: a meta-analysis. JAMA. 2006 Apr 19;295(15):1809-23.
- d'Arcangues C. Worldwide use of intrauterine devices for contraception. Contraception. 2007 Jun;75(6 Suppl):S2-7. Epub 2007 Apr 19. Review.
- De la Cruz D, Cruz A, Arteaga M, Castillo L, Tovalin H. Blood copper levels in Mexican users of the T380A IUD. Contraception. 2005 Aug;72(2):122-5.
- 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.
- Finer LB, Zolna MR. Unintended pregnancy in the United States: incidence and disparities, 2006. Contraception. 2011 Nov;84(5):478-85. doi: 10.1016/j.contraception.2011.07.013. Epub 2011 Aug 24.
- Grimes DA, Lopez LM, Schulz KF, Van Vliet HA, Stanwood NL. Immediate post-partum insertion of intrauterine devices. Cochrane Database Syst Rev. 2010 May 12;(5):CD003036. doi: 10.1002/14651858.CD003036.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;6:CD003036.
- Hayes JL, Cwiak C, Goedken P, Zieman M. A pilot clinical trial of ultrasound-guided postplacental insertion of a levonorgestrel intrauterine device. Contraception. 2007 Oct;76(4):292-6. Epub 2007 Aug 6.
- Inal MM, Ertopçu K, Ozelmas I. The evaluation of 318 intrauterine pregnancy cases with an intrauterine device. Eur J Contracept Reprod Health Care. 2005 Dec;10(4):266-71.
- Jackson RA, Schwarz EB, Freedman L, Darney P. Advance supply of emergency contraception. effect on use and usual contraception--a randomized trial. Obstet Gynecol. 2003 Jul;102(1):8-16.
- Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009 Oct;80(4):327-36. doi: 10.1016/j.contraception.2009.03.024. Epub 2009 Aug 29. Review.
- Long-term reversible contraception. Twelve years of experience with the TCu380A and TCu220C. Contraception. 1997 Dec;56(6):341-52.
- 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.
- Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.
- Ogburn JA, Espey E, Stonehocker J. Barriers to intrauterine device insertion in postpartum women. Contraception. 2005 Dec;72(6):426-9. Epub 2005 Aug 9.
- Prescott GM, Matthews CM. Long-acting reversible contraception: a review in special populations. Pharmacotherapy. 2014 Jan;34(1):46-59. doi: 10.1002/phar.1358. Epub 2013 Oct 15. Review.
- Sivin I, el Mahgoub S, McCarthy T, Mishell DR Jr, Shoupe D, Alvarez F, Brache V, Jimenez E, Diaz J, Faundes A, et al. Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T 380Ag intrauterine devices: a five-year randomized study. Contraception. 1990 Oct;42(4):361-78. Erratum in: Contraception 1991 Jan;43(1):100.
- 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.
- Speroff L, Mishell DR Jr. The postpartum visit: it's time for a change in order to optimally initiate contraception. Contraception. 2008 Aug;78(2):90-8. doi: 10.1016/j.contraception.2008.04.005. Epub 2008 Jun 12.
- The TCu380A, TCu220C, multiload 250 and Nova T IUDS at 3,5 and 7 years of use--results from three randomized multicentre trials. World Health Organization. Special Programme of Research, Development and Research Training in Human Reproduction: Task Force on the Safety and Efficacy of Fertility Regulating Methods. Contraception. 1990 Aug;42(2):141-58.
- Thonneau PF, Almont T. Contraceptive efficacy of intrauterine devices. Am J Obstet Gynecol. 2008 Mar;198(3):248-53. doi: 10.1016/j.ajog.2007.10.787. Epub 2008 Jan 25. Review. Erratum in: Am J Obstet Gynecol. 2008 Apr;198(4):485. Almont, Thierry E [corrected to Almont, Thierry].
- Winner B, Peipert JF, Zhao Q, Buckel C, Madden T, Allsworth JE, Secura GM. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012 May 24;366(21):1998-2007. doi: 10.1056/NEJMoa1110855.
- Xu JX, Rivera R, Dunson TR, Zhuang LQ, Yang XL, Ma GT, Chi IC. A comparative study of two techniques used in immediate postplacental insertion (IPPI) of the Copper T-380A IUD in Shanghai, People's Republic of China. Contraception. 1996 Jul;54(1):33-8.
- Zhu BP, Rolfs RT, Nangle BE, Horan JM. Effect of the interval between pregnancies on perinatal outcomes. N Engl J Med. 1999 Feb 25;340(8):589-94.
- 13-3264
Study Results
Participant Flow
Recruitment Details | This prospective cohort trial was conducted at 2 affiliated teaching hospitals: University of Colorado Hospital (UCH) in Aurora, CO, and Denver Health Medical Center (DHMC) in Denver, CO. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Mirena Group | Paragard Group |
---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. |
Period Title: Overall Study | ||
STARTED | 68 | 55 |
COMPLETED | 55 | 41 |
NOT COMPLETED | 13 | 14 |
Baseline Characteristics
Arm/Group Title | Mirena Group | Paragard Group | Total |
---|---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. | Total of all reporting groups |
Overall Participants | 68 | 55 | 123 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
26.2
(5.3)
|
27.4
(5.4)
|
26.72
(5.35)
|
Sex: Female, Male (Count of Participants) | |||
Female |
68
100%
|
55
100%
|
123
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
26
38.2%
|
36
65.5%
|
62
50.4%
|
Not Hispanic or Latino |
42
61.8%
|
19
34.5%
|
61
49.6%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
19
27.9%
|
9
16.4%
|
28
22.8%
|
White |
38
55.9%
|
36
65.5%
|
74
60.2%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
11
16.2%
|
10
18.2%
|
21
17.1%
|
Region of Enrollment (participants) [Number] | |||
United States |
68
100%
|
55
100%
|
123
100%
|
Outcome Measures
Title | IUD Expulsion Rate |
---|---|
Description | The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm. |
Time Frame | 3 months postpartum |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Mirena Group | Paragard Group |
---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. |
Measure Participants | 55 | 41 |
Count of Participants [Participants] |
20
29.4%
|
7
12.7%
|
Title | Pregnancy |
---|---|
Description | A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated. |
Time Frame | 6 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Mirena Group | Paragard Group |
---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. |
Measure Participants | 56 | 45 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Pregnancy |
---|---|
Description | A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Mirena Group | Paragard Group |
---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. |
Measure Participants | 56 | 45 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Complications |
---|---|
Description | A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Mirena Group | Paragard Group |
---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. |
Measure Participants | 55 | 41 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Satisfaction |
---|---|
Description | A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of >= 8 are reported by percent of participants. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Mirena Group | Paragard Group |
---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. |
Measure Participants | 35 | 34 |
Number [percent of participants] |
91.4
134.4%
|
94.2
171.3%
|
Title | Intrauterine Device Expulsion (Day 1) |
---|---|
Description | Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound. |
Time Frame | Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Mirena Group | Paragard Group |
---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. |
Measure Participants | 56 | 45 |
Number [participants] |
0
0%
|
0
0%
|
Title | Intrauterine Device Expulsion (6 Weeks) |
---|---|
Description | Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound. |
Time Frame | 6 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Mirena Group | Paragard Group |
---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. |
Measure Participants | 56 | 45 |
Number [participants] |
18
26.5%
|
6
10.9%
|
Title | Intrauterine Device Expulsion by 12 Weeks Postpartum |
---|---|
Description | Position of the IUD within the uterus will be documented by ultrasound. |
Time Frame | 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Mirena Group | Paragard Group |
---|---|---|
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. |
Measure Participants | 55 | 41 |
Count of Participants [Participants] |
21
30.9%
|
8
14.5%
|
Adverse Events
Time Frame | Adverse event information was collected from the time of consent until completion of participation (12 weeks). | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Mirena Group | Paragard Group | ||
Arm/Group Description | Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. | Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. | ||
All Cause Mortality |
||||
Mirena Group | Paragard Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Mirena Group | Paragard Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/68 (0%) | 0/55 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Mirena Group | Paragard Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/68 (0%) | 0/55 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Lisa Goldthwaite |
---|---|
Organization | Stanford University School of Medicine |
Phone | 541-515-1825 |
lgoldthw@stanford.edu |
- 13-3264