Quick Start Insertion of Mirena and ParaGard

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Paula Castano, Columbia University
ClinicalTrials.gov Identifier:
NCT01730911
First received: November 16, 2012
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Bleeding
Cramping
Pregnancy With IUD in Place
IUD Expulsion
IUD Removal
Other: Text message

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Quick Start Insertion of Mirena and ParaGard Intrauterine Contraceptive Devices

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of bleeding and cramping days [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: August 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ParaGard, paper diaries
Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries on paper.
Active Comparator: ParaGard, text message
Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries via text message.
Other: Text message
Participants will receive daily text messages to report bleeding and cramping experienced, if they are randomized to this arm.
No Intervention: Mirena, paper diaries
Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries on paper.
Active Comparator: Mirena, text message
Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries via text message.
Other: Text message
Participants will receive daily text messages to report bleeding and cramping experienced, if they are randomized to this arm.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730911

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Society of Family Planning
Investigators
Principal Investigator: Paula Castaño, MD, MPH Columbia University
  More Information

Publications:

Responsible Party: Paula Castano, Assistant Clinical Professor of Obstetrics and Gynecology, Columbia University
ClinicalTrials.gov Identifier: NCT01730911     History of Changes
Other Study ID Numbers: AAAJ3059
Study First Received: November 16, 2012
Last Updated: September 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Bleeding
Cramping
Pregnancy with intrauterine device in place
Intrauterine device expulsion
Intrauterine device removal

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014