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Quick Start Insertion of Mirena and ParaGard

Primary Purpose

Bleeding, Cramping, Pregnancy With IUD in Place

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text message
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bleeding focused on measuring Bleeding, Cramping, Pregnancy with intrauterine device in place, Intrauterine device expulsion, Intrauterine device removal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Receiving Mirena or ParaGard intrauterine device for contraception
  • Speak English or Spanish

Exclusion Criteria:

  • Do not use a cell phone
  • Unable/unwilling to fill out daily bleeding diaries

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

No Intervention

Active Comparator

Arm Label

ParaGard, paper diaries

ParaGard, text message

Mirena, paper diaries

Mirena, text message

Arm Description

Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries on paper.

Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries via text message.

Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries on paper.

Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries via text message.

Outcomes

Primary Outcome Measures

Number of bleeding and cramping days

Secondary Outcome Measures

Full Information

First Posted
November 16, 2012
Last Updated
September 22, 2014
Sponsor
Columbia University
Collaborators
Society of Family Planning
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1. Study Identification

Unique Protocol Identification Number
NCT01730911
Brief Title
Quick Start Insertion of Mirena and ParaGard
Official Title
Quick Start Insertion of Mirena and ParaGard Intrauterine Contraceptive Devices
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Society of Family Planning

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Intrauterine devices (IUDs) are an effective form of contraception, but only about 3.4% of women in the US report using them. Women must often wait for their menses to start, or for results of screening for sexually transmitted infections (STIs), before their doctors will place IUDs for them. This is not the case with other birth control methods. Researchers know that it is safe to start oral contraceptive pills, transdermal patches or vaginal rings on the same day of a doctor's visit. In the investigators clinical practice, the investigators often place IUDs on the same day of a woman's visit, but outcomes have not been formally assessed. Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A and the Mirena levonorgestrel intrauterine system (LNG-IUS). The investigators want to know if women who have IUDs placed at any time during their menstrual cycle have different experiences regarding the following, compared to those who have IUDS placed during the first 7 days of their cycle: bleeding or cramping patterns, active pelvic infections, becoming pregnant more often during that first cycle (window pregnancy). Women who come to their provider seeking an IUD for birth control will be asked to participate in this study. The investigators will ask them to keep track of their bleeding and cramping for three subsequent months to see if patterns differ according to the day in their menstrual cycle that the device was inserted. They will be randomly assigned either to record this information on paper, or to send in the information by responding to daily text messages. The investigators want to know if women who have an IUD placed at any time during the menstrual cycle have different outcomes compared to those who have IUDs placed during the first 7 days of their cycle. If the investigators have this information, the investigators can make recommendations to physicians, help counsel patients, and potentially expand access to IUDs.
Detailed Description
1. STUDY PURPOSE AND RATIONALE Intrauterine devices (IUDs) are an effective yet underutilized form of contraception in the United States. Only 5.5% of women age 15-44 reported using them in 2006-2008(Mosher 2010). Due to historical practices or prescribing recommendations, IUD insertion may be delayed if women must wait for results of screening for sexually transmitted infections (STIs) or for the beginning of their menstrual cycle. Such barriers are not as prevalent for other contraceptive methods. Initiation of oral contraceptive pills (OCPs), the vaginal ring, transdermal patches, and depot medroxyprogesterone acetate injection, with emergency contraception (EC) as indicated, is safely done on the same day of a woman's visit to her provider. This "Quick Start" approach improves access to birth control and has been well studied at the Family Planning Clinic at Columbia Presbyterian Medical Center and at other institutions (Westhoff 2002, Schafer 2006, Murthy 2005, Rickert 2007). The investigators providers often extend this practice to IUD insertion, but outcomes have not been formally assessed. If the investigators can show that insertion at any time is safe, the investigators can improve access. There are several concerns surrounding IUD insertion at the time of an initial visit to a health care provider. One problem with insertion outside the first week of the menstrual cycle may be "window" pregnancies those that occur during the first cycle with the IUD in place. For OCPs initiated with the Quick Start protocol, the pregnancy rate is approximately 2% (Westhoff 2007). No data exist for IUDs that insertion during any other part of the cycle differs with regard to number of window pregnancies. Another theoretical drawback to immediate IUD initiation is insertion in the setting of an undiagnosed STI. While the risk of developing pelvic inflammatory disease (PID) is highest in the 20 days postinsertion, the incidence of pelvic inflammatory disease among IUD users is rare and estimated at between 1:100 to 1:1,000 woman-years (Martinez 2009). Evidence does not support routine screening for sexually transmitted infections prior to IUD insertion for women at low risk for STIs, and testing should be done based on local prevalence data (Walsh 1998; Skjeldestad 1996). For women younger than 26 or with multiple sex partners, screening can be done on the same day of insertion. However, variation in individual provider practice patterns can be an additional barrier that delays IUD insertion and puts women at risk for interval pregnancies while awaiting IUD insertion. Alterations in cramping, expulsions, and bleeding patterns may or may not be associated with cycle day of insertion but nonetheless could contribute to satisfaction with and continuation rates of the IUD. In a 60 month study of TCu380A IUDs in Iran, approximately 25% of women discontinued the method due to bleeding and pain (Jenabi 2006). Another study done in Kuwait found that irregular or heavy bleeding was a common complaint (Alnakash 2008). Published data on these issues is sparse. Without evidence that alternatives are safe for the two IUDs that are currently available, physicians may be reluctant to individualize. An accurate assessment of bleeding patterns after IUD insertion rests on the quality of data gathered. In 2005, Mishell issued guidelines for standardization of data collection and analysis of bleeding patterns for combined hormone contraceptive trials, and noted the need for prospective comparative studies of the accuracy of electronic data collection versus paper diaries (Mishell, 2005). There are no published data comparing the quality and quantity of information obtained using these two methods, but text messages are increasingly used to collect data in clinical trials. This study affords us the opportunity to compare this new modality with existing methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Cramping, Pregnancy With IUD in Place, IUD Expulsion, IUD Removal
Keywords
Bleeding, Cramping, Pregnancy with intrauterine device in place, Intrauterine device expulsion, Intrauterine device removal

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ParaGard, paper diaries
Arm Type
No Intervention
Arm Description
Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries on paper.
Arm Title
ParaGard, text message
Arm Type
Active Comparator
Arm Description
Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries via text message.
Arm Title
Mirena, paper diaries
Arm Type
No Intervention
Arm Description
Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries on paper.
Arm Title
Mirena, text message
Arm Type
Active Comparator
Arm Description
Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries via text message.
Intervention Type
Other
Intervention Name(s)
Text message
Intervention Description
Participants will receive daily text messages to report bleeding and cramping experienced, if they are randomized to this arm.
Primary Outcome Measure Information:
Title
Number of bleeding and cramping days
Time Frame
3 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Receiving Mirena or ParaGard intrauterine device for contraception Speak English or Spanish Exclusion Criteria: Do not use a cell phone Unable/unwilling to fill out daily bleeding diaries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Castaño, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18847576
Citation
Alnakash AH. Influence of IUD perceptions on method discontinuation. Contraception. 2008 Oct;78(4):290-3. doi: 10.1016/j.contraception.2008.05.009. Epub 2008 Jul 30.
Results Reference
background
PubMed Identifier
2052804
Citation
Belsey EM, Carlson N. The description of menstrual bleeding patterns: towards fewer measures. Stat Med. 1991 Feb;10(2):267-84. doi: 10.1002/sim.4780100210.
Results Reference
background
PubMed Identifier
22143257
Citation
Castano PM, Bynum JY, Andres R, Lara M, Westhoff C. Effect of daily text messages on oral contraceptive continuation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):14-20. doi: 10.1097/AOG.0b013e31823d4167.
Results Reference
background
PubMed Identifier
17157106
Citation
Jenabi E, Alizade SM, Baga RI. Continuation rates and reasons for discontinuing TCu380A IUD use in Tabriz, Iran. Contraception. 2006 Dec;74(6):483-6. doi: 10.1016/j.contraception.2006.08.007. Epub 2006 Oct 13.
Results Reference
background
PubMed Identifier
19172421
Citation
Martinez F, Lopez-Arregui E. Infection risk and intrauterine devices. Acta Obstet Gynecol Scand. 2009;88(3):246-50. doi: 10.1080/00016340802707473.
Results Reference
background
PubMed Identifier
17161117
Citation
Mishell DR Jr, Guillebaud J, Westhoff C, Nelson AL, Kaunitz AM, Trussell J, Davis AJ. Recommendations for standardization of data collection and analysis of bleeding in combined hormone contraceptive trials. Contraception. 2007 Jan;75(1):11-5. doi: 10.1016/j.contraception.2006.08.012. Epub 2006 Oct 11.
Results Reference
background
PubMed Identifier
20939159
Citation
Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.
Results Reference
background
PubMed Identifier
16246657
Citation
Murthy AS, Creinin MD, Harwood B, Schreiber CA. Same-day initiation of the transdermal hormonal delivery system (contraceptive patch) versus traditional initiation methods. Contraception. 2005 Nov;72(5):333-6. doi: 10.1016/j.contraception.2005.05.009. Epub 2005 Aug 9.
Results Reference
background
PubMed Identifier
17185202
Citation
Rickert VI, Tiezzi L, Lipshutz J, Leon J, Vaughan RD, Westhoff C. Depo Now: preventing unintended pregnancies among adolescents and young adults. J Adolesc Health. 2007 Jan;40(1):22-8. doi: 10.1016/j.jadohealth.2006.10.018.
Results Reference
background
PubMed Identifier
16627032
Citation
Schafer JE, Osborne LM, Davis AR, Westhoff C. Acceptability and satisfaction using Quick Start with the contraceptive vaginal ring versus an oral contraceptive. Contraception. 2006 May;73(5):488-92. doi: 10.1016/j.contraception.2005.11.003. Epub 2006 Jan 3.
Results Reference
background
PubMed Identifier
8922873
Citation
Skjeldestad FE, Halvorsen LE, Kahn H, Nordbo SA, Saake K. IUD users in Norway are at low risk for genital C. trachomatis infection. Contraception. 1996 Oct;54(4):209-12. doi: 10.1016/s0010-7824(96)00190-4.
Results Reference
background
PubMed Identifier
9546505
Citation
Walsh T, Grimes D, Frezieres R, Nelson A, Bernstein L, Coulson A, Bernstein G. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Lancet. 1998 Apr 4;351(9108):1005-8. doi: 10.1016/s0140-6736(97)09086-7.
Results Reference
background
PubMed Identifier
12384200
Citation
Westhoff C, Kerns J, Morroni C, Cushman LF, Tiezzi L, Murphy PA. Quick start: novel oral contraceptive initiation method. Contraception. 2002 Sep;66(3):141-5. doi: 10.1016/s0010-7824(02)00351-7.
Results Reference
background
PubMed Identifier
17540797
Citation
Westhoff C, Heartwell S, Edwards S, Zieman M, Cushman L, Robilotto C, Stuart G, Morroni C, Kalmuss D. Initiation of oral contraceptives using a quick start compared with a conventional start: a randomized controlled trial. Obstet Gynecol. 2007 Jun;109(6):1270-6. doi: 10.1097/01.AOG.0000264550.41242.f2.
Results Reference
background

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Quick Start Insertion of Mirena and ParaGard

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