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Quick Start Insertion of Mirena and ParaGard

NCT01730911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2014-09-25

No results posted yet for this study

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.

Conditions

  • Bleeding
  • Cramping
  • Pregnancy With IUD in Place
  • IUD Expulsion
  • IUD Removal

Interventions

OTHER

Text message

Participants will receive daily text messages to report bleeding and cramping experienced, if they are randomized to this arm.

Sponsors & Collaborators

Principal Investigators

  • Paula Castaño, MD, MPH · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01730911 on ClinicalTrials.gov