SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02311478

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

(TRIBE) Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users

This study aims to use validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD.

NCT02311478 Intrauterine Devices, Copper Metrorrhagia Menstruation Menstrual Cycle
MeSH: Hemorrhage Metrorrhagia
HPO: Metrorrhagia

1 Interventions

Name: T380A Intrauterine Copper Contraceptive

Description: The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus.

Type: Device

T380A Copper IUD


Primary Outcomes

Description: Women will track bleeding after the insertion of the T380A IUD for 180 days. Participants will be contacted monthly to collect data.

Measure: Evaluate changes in frequency, duration, and quantity of bleeding patterns among women initiating the copper T380 IUD during the 90 days prior to initiation compared to two 90 periods after IUD insertion.

Time: 180 days

Secondary Outcomes

Description: Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.

Measure: Assess the relationship of menstrual cycle changes among women initiating the copper T380 IUD to method satisfaction, acceptability, and continuation at 6 months post insertion.

Time: 180 days

Description: Use reported measures at baseline, 1 month, 3 months, and 6 months to examine the relationship between bleeding patterns and sexual satisfaction.

Measure: Assess the relationship of menstrual cycle changes among women initiating the copper T380 IUD to sexual functioning and satisfaction.

Time: 180 days

Purpose: Supportive Care

Single Group Assignment


There is one SNP

SNPs


1 T380A

Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users This study aims to use validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD. --- T380A ---

Evaluate changes in frequency, duration, and quantity of bleeding patterns among women initiating the copper T380 IUD during the 90 days prior to initiation compared to two 90 periods after IUD insertion.. Women will track bleeding after the insertion of the T380A IUD for 180 days. --- T380A ---

Participants will be contacted monthly to collect data.. Assess the relationship of menstrual cycle changes among women initiating the copper T380 IUD to method satisfaction, acceptability, and continuation at 6 months post insertion.. Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.. Assess the relationship of menstrual cycle changes among women initiating the copper T380 IUD to sexual functioning and satisfaction.. Use reported measures at baseline, 1 month, 3 months, and 6 months to examine the relationship between bleeding patterns and sexual satisfaction.. Inclusion Criteria: - Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD - Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days - Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles) Exclusion Criteria: - Use of any hormonal contraceptive method in the previous 3 months - Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days) - Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles - Contraindication to use of the ParaGard® T380A IUD - Mucopurulent cervicitis at the time of IUD insertion - Unable to speak, read, and write in English - Currently pregnant - Plans for or desire for pregnancy in the next 6 months - Currently breastfeeding - Women who are <6 months postpartum - Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment - Wilson's disease - Known coagulopathy or bleeding disorder Inclusion Criteria: - Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD - Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days - Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles) Exclusion Criteria: - Use of any hormonal contraceptive method in the previous 3 months - Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days) - Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles - Contraindication to use of the ParaGard® T380A IUD - Mucopurulent cervicitis at the time of IUD insertion - Unable to speak, read, and write in English - Currently pregnant - Plans for or desire for pregnancy in the next 6 months - Currently breastfeeding - Women who are <6 months postpartum - Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment - Wilson's disease - Known coagulopathy or bleeding disorder Intrauterine Devices, Copper Metrorrhagia Menstruation Menstrual Cycle Hemorrhage Metrorrhagia New users of the intrauterine device (IUD) are most likely to discontinue use within the first six months after insertion. --- T380A ---

Participants will be contacted monthly to collect data.. Assess the relationship of menstrual cycle changes among women initiating the copper T380 IUD to method satisfaction, acceptability, and continuation at 6 months post insertion.. Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.. Assess the relationship of menstrual cycle changes among women initiating the copper T380 IUD to sexual functioning and satisfaction.. Use reported measures at baseline, 1 month, 3 months, and 6 months to examine the relationship between bleeding patterns and sexual satisfaction.. Inclusion Criteria: - Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD - Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days - Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles) Exclusion Criteria: - Use of any hormonal contraceptive method in the previous 3 months - Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days) - Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles - Contraindication to use of the ParaGard® T380A IUD - Mucopurulent cervicitis at the time of IUD insertion - Unable to speak, read, and write in English - Currently pregnant - Plans for or desire for pregnancy in the next 6 months - Currently breastfeeding - Women who are <6 months postpartum - Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment - Wilson's disease - Known coagulopathy or bleeding disorder Inclusion Criteria: - Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD - Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days - Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles) Exclusion Criteria: - Use of any hormonal contraceptive method in the previous 3 months - Irregular duration of menstrual cycles in the last 3 cycles (<21 or >35 days) - Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles - Contraindication to use of the ParaGard® T380A IUD - Mucopurulent cervicitis at the time of IUD insertion - Unable to speak, read, and write in English - Currently pregnant - Plans for or desire for pregnancy in the next 6 months - Currently breastfeeding - Women who are <6 months postpartum - Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment - Wilson's disease - Known coagulopathy or bleeding disorder Intrauterine Devices, Copper Metrorrhagia Menstruation Menstrual Cycle Hemorrhage Metrorrhagia New users of the intrauterine device (IUD) are most likely to discontinue use within the first six months after insertion. --- T380A --- --- T380A ---

This study aims to incorporate these validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD. --- T380A ---



HPO Nodes


HPO:
Metrorrhagia
Genes 13
NPM1 PRKAR1A TBL1XR1 CDH23 FLI1 FIP1L1 USP8 ZBTB16 STAT5B RARA PML NABP1 NUMA1