<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01730911</url>
  </required_header>
  <id_info>
    <org_study_id>AAAJ3059</org_study_id>
    <nct_id>NCT01730911</nct_id>
  </id_info>
  <brief_title>Quick Start Insertion of Mirena and ParaGard</brief_title>
  <official_title>Quick Start Insertion of Mirena and ParaGard Intrauterine Contraceptive Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society of Family Planning</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intrauterine devices (IUDs) are an effective form of contraception, but only about 3.4% of&#xD;
      women in the US report using them. Women must often wait for their menses to start, or for&#xD;
      results of screening for sexually transmitted infections (STIs), before their doctors will&#xD;
      place IUDs for them. This is not the case with other birth control methods. Researchers know&#xD;
      that it is safe to start oral contraceptive pills, transdermal patches or vaginal rings on&#xD;
      the same day of a doctor's visit. In the investigators clinical practice, the investigators&#xD;
      often place IUDs on the same day of a woman's visit, but outcomes have not been formally&#xD;
      assessed.&#xD;
&#xD;
      Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A and&#xD;
      the Mirena levonorgestrel intrauterine system (LNG-IUS). The investigators want to know if&#xD;
      women who have IUDs placed at any time during their menstrual cycle have different&#xD;
      experiences regarding the following, compared to those who have IUDS placed during the first&#xD;
      7 days of their cycle: bleeding or cramping patterns, active pelvic infections, becoming&#xD;
      pregnant more often during that first cycle (window pregnancy).&#xD;
&#xD;
      Women who come to their provider seeking an IUD for birth control will be asked to&#xD;
      participate in this study. The investigators will ask them to keep track of their bleeding&#xD;
      and cramping for three subsequent months to see if patterns differ according to the day in&#xD;
      their menstrual cycle that the device was inserted. They will be randomly assigned either to&#xD;
      record this information on paper, or to send in the information by responding to daily text&#xD;
      messages.&#xD;
&#xD;
      The investigators want to know if women who have an IUD placed at any time during the&#xD;
      menstrual cycle have different outcomes compared to those who have IUDs placed during the&#xD;
      first 7 days of their cycle. If the investigators have this information, the investigators&#xD;
      can make recommendations to physicians, help counsel patients, and potentially expand access&#xD;
      to IUDs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. STUDY PURPOSE AND RATIONALE Intrauterine devices (IUDs) are an effective yet underutilized&#xD;
      form of contraception in the United States. Only 5.5% of women age 15-44 reported using them&#xD;
      in 2006-2008(Mosher 2010). Due to historical practices or prescribing recommendations, IUD&#xD;
      insertion may be delayed if women must wait for results of screening for sexually transmitted&#xD;
      infections (STIs) or for the beginning of their menstrual cycle. Such barriers are not as&#xD;
      prevalent for other contraceptive methods. Initiation of oral contraceptive pills (OCPs), the&#xD;
      vaginal ring, transdermal patches, and depot medroxyprogesterone acetate injection, with&#xD;
      emergency contraception (EC) as indicated, is safely done on the same day of a woman's visit&#xD;
      to her provider. This &quot;Quick Start&quot; approach improves access to birth control and has been&#xD;
      well studied at the Family Planning Clinic at Columbia Presbyterian Medical Center and at&#xD;
      other institutions (Westhoff 2002, Schafer 2006, Murthy 2005, Rickert 2007). The&#xD;
      investigators providers often extend this practice to IUD insertion, but outcomes have not&#xD;
      been formally assessed. If the investigators can show that insertion at any time is safe, the&#xD;
      investigators can improve access.&#xD;
&#xD;
      There are several concerns surrounding IUD insertion at the time of an initial visit to a&#xD;
      health care provider. One problem with insertion outside the first week of the menstrual&#xD;
      cycle may be &quot;window&quot; pregnancies those that occur during the first cycle with the IUD in&#xD;
      place. For OCPs initiated with the Quick Start protocol, the pregnancy rate is approximately&#xD;
      2% (Westhoff 2007). No data exist for IUDs that insertion during any other part of the cycle&#xD;
      differs with regard to number of window pregnancies. Another theoretical drawback to&#xD;
      immediate IUD initiation is insertion in the setting of an undiagnosed STI. While the risk of&#xD;
      developing pelvic inflammatory disease (PID) is highest in the 20 days postinsertion, the&#xD;
      incidence of pelvic inflammatory disease among IUD users is rare and estimated at between&#xD;
      1:100 to 1:1,000 woman-years (Martinez 2009). Evidence does not support routine screening for&#xD;
      sexually transmitted infections prior to IUD insertion for women at low risk for STIs, and&#xD;
      testing should be done based on local prevalence data (Walsh 1998; Skjeldestad 1996). For&#xD;
      women younger than 26 or with multiple sex partners, screening can be done on the same day of&#xD;
      insertion. However, variation in individual provider practice patterns can be an additional&#xD;
      barrier that delays IUD insertion and puts women at risk for interval pregnancies while&#xD;
      awaiting IUD insertion.&#xD;
&#xD;
      Alterations in cramping, expulsions, and bleeding patterns may or may not be associated with&#xD;
      cycle day of insertion but nonetheless could contribute to satisfaction with and continuation&#xD;
      rates of the IUD. In a 60 month study of TCu380A IUDs in Iran, approximately 25% of women&#xD;
      discontinued the method due to bleeding and pain (Jenabi 2006). Another study done in Kuwait&#xD;
      found that irregular or heavy bleeding was a common complaint (Alnakash 2008). Published data&#xD;
      on these issues is sparse. Without evidence that alternatives are safe for the two IUDs that&#xD;
      are currently available, physicians may be reluctant to individualize.&#xD;
&#xD;
      An accurate assessment of bleeding patterns after IUD insertion rests on the quality of data&#xD;
      gathered. In 2005, Mishell issued guidelines for standardization of data collection and&#xD;
      analysis of bleeding patterns for combined hormone contraceptive trials, and noted the need&#xD;
      for prospective comparative studies of the accuracy of electronic data collection versus&#xD;
      paper diaries (Mishell, 2005). There are no published data comparing the quality and quantity&#xD;
      of information obtained using these two methods, but text messages are increasingly used to&#xD;
      collect data in clinical trials. This study affords us the opportunity to compare this new&#xD;
      modality with existing methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of bleeding and cramping days</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Bleeding</condition>
  <condition>Cramping</condition>
  <condition>Pregnancy With IUD in Place</condition>
  <condition>IUD Expulsion</condition>
  <condition>IUD Removal</condition>
  <arm_group>
    <arm_group_label>ParaGard, paper diaries</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries on paper.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ParaGard, text message</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries via text message.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirena, paper diaries</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries on paper.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirena, text message</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries via text message.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Text message</intervention_name>
    <description>Participants will receive daily text messages to report bleeding and cramping experienced, if they are randomized to this arm.</description>
    <arm_group_label>Mirena, text message</arm_group_label>
    <arm_group_label>ParaGard, text message</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Receiving Mirena or ParaGard intrauterine device for contraception&#xD;
&#xD;
          -  Speak English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not use a cell phone&#xD;
&#xD;
          -  Unable/unwilling to fill out daily bleeding diaries&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paula Castaño, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>18847576</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>2052804</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22143257</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17157106</PMID>
  </reference>
  <reference>
    <citation>Martinez F, Lopez-Arregui E. Infection risk and intrauterine devices. Acta Obstet Gynecol Scand. 2009;88(3):246-50. doi: 10.1080/00016340802707473.</citation>
    <PMID>19172421</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17161117</PMID>
  </reference>
  <reference>
    <citation>Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.</citation>
    <PMID>20939159</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16246657</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17185202</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16627032</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>8922873</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>9546505</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12384200</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17540797</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Paula Castano</investigator_full_name>
    <investigator_title>Assistant Clinical Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>Bleeding</keyword>
  <keyword>Cramping</keyword>
  <keyword>Pregnancy with intrauterine device in place</keyword>
  <keyword>Intrauterine device expulsion</keyword>
  <keyword>Intrauterine device removal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Cramp</mesh_term>
    <mesh_term>Spasm</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01730911
org study id: AAAJ3059
nct id: NCT01730911
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of bleeding and cramping days
time frame: 3 months
arm group label: ParaGard, paper diaries
arm group type: No Intervention
description: Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries on paper.
arm group label: ParaGard, text message
arm group type: Active Comparator
description: Women who have chosen ParaGard IUDs as their contraception, and randomized to submit bleeding diaries via text message.
arm group label: Mirena, paper diaries
arm group type: No Intervention
description: Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries on paper.
arm group label: Mirena, text message
arm group type: Active Comparator
description: Women who have chosen Mirena IUDs as their contraception, and randomized to submit bleeding diaries via text message.
intervention type: Other
intervention name: Text message
description: Participants will receive daily text messages to report bleeding and cramping experienced, if they are randomized to this arm.
arm group label: Mirena, text message
arm group label: ParaGard, text message
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paula Castaño, MD, MPH
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
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.
PMID: 18847576
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.
PMID: 2052804
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.
PMID: 22143257
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.
PMID: 17157106
citation: Martinez F, Lopez-Arregui E. Infection risk and intrauterine devices. Acta Obstet Gynecol Scand. 2009;88(3):246-50. doi: 10.1080/00016340802707473.
PMID: 19172421
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.
PMID: 17161117
citation: Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.
PMID: 20939159
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.
PMID: 16246657
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.
PMID: 17185202
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.
PMID: 16627032
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.
PMID: 8922873
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.
PMID: 9546505
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responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Paula Castano
investigator title: Assistant Clinical Professor of Obstetrics and Gynecology
mesh term: Muscle Cramp
mesh term: Spasm
mesh term: Hemorrhage