Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) |
Pregnancy after sterilization or IUD placement, indicating failure |
Pregnancy rates at 3 months post-procedure |
|
Primary |
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) |
Pregnancy after sterilization or IUD placement, indicating failure |
Pregnancy rates at 6 months post-procedure |
|
Primary |
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) |
Pregnancy after sterilization or IUD placement, indicating failure |
Pregnancy rates at 12 months post-procedure |
|
Primary |
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) |
Pregnancy after sterilization or IUD placement, indicating failure |
Pregnancy rates at 24 months post-procedure |
|
Primary |
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) |
Pregnancy after sterilization or IUD placement, indicating failure |
Pregnancy rates at 36 months post-procedure |
|
Primary |
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) |
Pregnancy after sterilization or IUD placement, indicating failure |
Pregnancy rates at 48 months post-procedure |
|
Primary |
Effectiveness of hysteroscopic compared to laparoscopic sterilization and IUD placement (Aim 1a) |
Pregnancy after sterilization or IUD placement, indicating failure |
Pregnancy rates at 60 months post-procedure |
|
Secondary |
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) |
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs |
3 months post-procedure |
|
Secondary |
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) |
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs |
6 months post-procedure |
|
Secondary |
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) |
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs |
12 months post-procedure |
|
Secondary |
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) |
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs |
24 months post-procedure |
|
Secondary |
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) |
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs |
36 months post-procedure |
|
Secondary |
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) |
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs |
48 months post-procedure |
|
Secondary |
Blocked fallopian tubes on post-procedure hysterosalpingogram test (Aim 1b) |
Ability to rely on sterilization after hysteroscopic sterilization (assessed by having blocked tubes on post-procedure hysterosalpingogram test) compared to laparoscopic sterilization and IUDs |
60 months post-procedure |
|
Secondary |
Reoperation to achieve sterilization or reinsertion to achieve IUD placement |
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement |
3 months post-procedure |
|
Secondary |
Reoperation to achieve sterilization or reinsertion to achieve IUD placement |
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement |
6 months post-procedure |
|
Secondary |
Reoperation to achieve sterilization or reinsertion to achieve IUD placement |
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement |
12 months post-procedure |
|
Secondary |
Reoperation to achieve sterilization or reinsertion to achieve IUD placement |
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement |
24 months post-procedure |
|
Secondary |
Reoperation to achieve sterilization or reinsertion to achieve IUD placement |
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement |
36 months post-procedure |
|
Secondary |
Reoperation to achieve sterilization or reinsertion to achieve IUD placement |
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement |
48 months post-procedure |
|
Secondary |
Reoperation to achieve sterilization or reinsertion to achieve IUD placement |
Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD placement |
60 months post-procedure |
|
Secondary |
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) |
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy |
3 months post-procedure |
|
Secondary |
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) |
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy |
6 months post-procedure |
|
Secondary |
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) |
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy |
12 months post-procedure |
|
Secondary |
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) |
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy |
24 months post-procedure |
|
Secondary |
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) |
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy |
36 months post-procedure |
|
Secondary |
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) |
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy |
48 months post-procedure |
|
Secondary |
Need for subsequent surgery to remove foreign body, remove fallopian tube(s) (salpingectomy), or uterus (hysterectomy) |
Need for surgical procedure after hysteroscopic or laparoscopic sterilization or IUD placement as assessed by surgery to remove foreign body, salpingectomy, or hysterectomy |
60 months post-procedure |
|
Secondary |
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics |
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement |
3 months post-procedure |
|
Secondary |
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics |
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement |
6 months post-procedure |
|
Secondary |
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics |
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement |
12 months post-procedure |
|
Secondary |
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics |
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement |
24 months post-procedure |
|
Secondary |
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics |
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement |
36 months post-procedure |
|
Secondary |
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics |
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement |
48 months post-procedure |
|
Secondary |
Number of participants with new onset chronic pain as assessed by new prescriptions for narcotics |
New prescription for narcotics after hysteroscopic compared to laparoscopic sterilization and IUD placement |
60 months post-procedure |
|
Secondary |
Number of participants with new onset depression as assessed by new prescriptions for antidepressants |
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement |
3 months post-procedure |
|
Secondary |
Number of participants with new onset depression as assessed by new prescriptions for antidepressants |
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement |
6 months post-procedure |
|
Secondary |
Number of participants with new onset depression as assessed by new prescriptions for antidepressants |
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement |
12 months post-procedure |
|
Secondary |
Number of participants with new onset depression as assessed by new prescriptions for antidepressants |
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement |
24 months post-procedure |
|
Secondary |
Number of participants with new onset depression as assessed by new prescriptions for antidepressants |
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement |
36 months post-procedure |
|
Secondary |
Number of participants with new onset depression as assessed by new prescriptions for antidepressants |
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement |
48 months post-procedure |
|
Secondary |
Number of participants with new onset depression as assessed by new prescriptions for antidepressants |
New prescription for anti-depressant medication after hysteroscopic compared to laparoscopic sterilization and IUD placement |
60 months post-procedure |
|
Secondary |
Pre-procedure clinical variables associated with procedural complications |
Identify sociodemographic and pre-procedure clinical variables which may predict complications following hysteroscopic sterilization compared to laparoscopic sterilization and IUD placement |
Up to 1-year pre-procedure |
|