MEDICAL HISTORY | ||
Reproductive/ Gynecological History (5) | Pregnancy History - Number of Previous Pregnancies Pregnancy History - Outcome of Previous Pregnancies (e.g., miscarriage, ectopic, etc.) Currently Breastfeeding? (Y/N) Menstruation History - Regular Cycles? (Y/N) Prior Conditions or Symptoms (specific conditions below) (Y/N)
| Pelvic inflammatory disease (PID) (Y/N) Breast Cancer (Y/N) Anovulatory Condition (Y/N) Cervical Conization (e.g., cone biopsy, LEEP procedure) (Y/N) Prior Sexually Transmitted Disease (STD -e.g., Gonorrhea, Syphilis, Chlamydia, Other prior STD) (Y/N) Gynecological Cancer (e.g., uterine cancer, ovarian cancer, cervical cancer) (Y/N) Acute cervicitis, vaginitis, or other lower genital tract infection (Y/N) Uterine abnormality that distorts cavity (Y/N) Absence of menstrual bleeding (Y/N) |
Surgical History (4) | Any prior intra-abdominal surgery? (Y/N)
| Any prior vaginal/hysteroscopic/cervical surgery? (Y/N)
|
General Medical History (7) | History of chronic pain (e.g., fibromyalgia) (Y/N) Prior Psychiatric Disorders (e.g., Depression, Anxiety, etc.) (Y/N) Autoimmune disease (Y/N) Bleeding disorder (Y/N) | Prior allergic or hypersensitivity reaction possibly or definitely related to materials/ substances used in the index procedure (Y/N)
|
PROCEDURE DATA: Index Procedure, Post-procedure Follow-up | ||
General Encounter Information (16) | On what date was the index procedure performed? During which time period was this performed? (select one of the options indented below) Interval (more than 6 weeks from delivery/abortion or unrelated to delivery) Post-abortal (same day as abortion / confirmation of abortion) Post-partum (if yes, select one of the options indented below)
Encounter Reason (e.g., New Sterilization/LARC Procedure, Post-Procedure Follow-up, etc.) Procedure Performed (e.g., Total Salpingectomy, Partial Salpingectomy, etc.) | Facility where procedure was performed Provider ID Number of Procedures Performed by the Provider in Last Six Months (same procedure performed that was listed above) Pre-procedure imaging? (Y/N)
Inter-procedure imaging? (Y/N)
Post-procedure imaging? (Y/N)
|
Other Procedures Performed in Conjunction with Sterilization Procedure (1) | Concomitant Procedures (e.g., c-section, hysteroscopic myomectomy, hysteroscopic polypectomy, hysteroscopic ablation, D&C, laparoscopic adnexal surgery, other) | |
Procedure Elements (Index Procedure or Follow-up) (7) | Product ID (e.g., Unique Device Identifier (UDI), National Drug Code (NDC)) Placement Success Achieved (Y/N) Fallopian Tube Treated - for hysteroscopic & surgical sterilizations only (e.g., Left, Right, Bilateral) Successful Visualization of Right/Left Tubal Ostia - for hysteroscopic sterilizations only (Y/N) | Primary Reason for Unsuccessful Placement (e.g., Procedure-related adverse event, poor distension, poor visualization, etc.) Intraoperative Findings - for hysteroscopic and surgical sterilizations only (e.g., Adhesions, Adnexal Mass, Fibroids, Endometriosis, etc.) Number of unsuccessful procedure attempts (for each unsuccessful attempt, specify reason) |
Product Removal Procedure-Specific Elements (7) | Unintended Removal by health care provider (e.g., During Dilation and Curettage, etc.) Planned Removal (Y/N) Reason for planned removal (e.g., Unable to rely on device, Pain, Bleeding, etc.) Other procedures performed with removal (e.g., Incisional Sterilization, Hysteroscopy, etc.) | Complete Device Removal (e.g., Intact Device, All Fragments Removed, N/A) Partial Removal (e.g., Device Breakage Prior to Removal, etc.) Any device or implant abnormalities (Y/N) |
MEDICATIONS | ||
Medications (20) | Pre-procedural Medication (Y/N)
Procedural Medication (Y/N)
| Discharge Medication (Y/N)
Follow-up Medication (Y/N)
|
ENDPOINTS DURING AND AFTER TREATMENT | ||
Events or Complications - Permanent Hysteroscopic Sterilization (23) | Hematoma formation (Yes/No | Procedure/Post-procedure | Date) Device expulsion (Yes/No | Procedure/Post-procedure | Date) Device malposition/migration/dislocation (Yes/No | Procedure/Post-procedure | Date) Nerve injury (Yes/No | Procedure/Post-procedure | Date) Thermal injury (Yes/No | Procedure/Post-procedure | Date) Visceral organ injury (Yes/No | Procedure/Post-procedure | Date) Perforation (Yes/No | Procedure/Post-procedure | Date | Specify Organ perforated) Vascular injury (Yes/No | Procedure/Post-procedure | Date) Venous thrombosis within 30 days of procedure (Yes/No | Procedure/Post-procedure | Date) Pulmonary Embolism within 30 days of procedure (Yes/No | Procedure/Post-procedure | Date) Pain requiring prescriptive medication (Yes/No | Procedure/Post-procedure | Date) | Vasovagal syncope or seizure on day of placement (Yes/No | Procedure/Post-procedure | Date) Pelvic inflammatory disease (PID) (Yes/No | Procedure/Post-procedure | Date) Other Infection (Yes/No | Procedure/Post-procedure | Date) Anesthesia-related event (Yes/No | Procedure/Post-procedure | Date) Inability to access fallopian tubes during procedure (Yes/No) Nausea or vomiting (Yes/No | Procedure/Post-procedure | Date) Fainting or dizziness (Yes/No | Procedure/Post-procedure | Date) Surgical hemorrhage (Yes/No) Other medical product related adverse event (AE) (Yes/No | Procedure/Post-procedure | Date) If yes, specify Other procedure related AE (Yes/No | Procedure/Post-procedure | Date) If yes, specify |
Events or Complications - All Other Permanent Surgical Sterilization (24) | Hematoma formation (Yes/No | Procedure/Post-procedure | Date) Device expulsion (Yes/No | Procedure/Post-procedure | Date) Device malposition/migration/dislocation (Yes/No | Procedure/Post-procedure | Date) Nerve injury (Yes/No | Procedure/Post-procedure | Date) Thermal injury (Yes/No | Procedure/Post-procedure | Date) Visceral organ injury (Yes/No | Procedure/Post-procedure | Date) Perforation (Yes/No | Procedure/Post-procedure | Date | Specify Organ perforated) Vascular injury (Yes/No | Procedure/Post-procedure | Date) Venous thrombosis within 30 days of procedure (Yes/No | Procedure/Post-procedure | Date) Pulmonary Embolism within 30 days of procedure (Yes/No | Procedure/Post-procedure | Date) Pain requiring prescriptive medication (Yes/No | Procedure/Post-procedure | Date) | Vasovagal syncope or seizure on day of placement (Yes/No | Procedure/Post-procedure | Date) Subcutaneous emphysema (Yes/No | Procedure/Post-procedure | Date) Pelvic inflammatory disease (PID) (Yes/No | Procedure/Post-procedure | Date) Other Infection (Yes/No | Procedure/Post-procedure | Date) Anesthesia-related event (Yes/No | Procedure/Post-procedure | Date) Inability to access fallopian tubes during procedure (Yes/No) Nausea or vomiting (Yes/No | Procedure/Post-procedure | Date) Fainting or dizziness (Yes/No | Procedure/Post-procedure | Date) Surgical hemorrhage (Yes/No) Other medical product related AE (Yes/No | Procedure/Post-procedure | Date) If yes, specify Other procedure related AE (Yes/No | Procedure/Post-procedure | Date) If yes, specify |
Events or Complications - LARC – Contraceptive Implants (15) | Hematoma formation (Yes/No | Procedure/Post-procedure | Date) Device expulsion (Yes/No | Procedure/Post-procedure | Date) Device malposition/migration/dislocation (Yes/No | Procedure/Post-procedure | Date) Nerve injury (Yes/No | Procedure/Post-procedure | Date) Vascular injury (Yes/No | Procedure/Post-procedure | Date) Venous thrombosis within 30 days of procedure (Yes/No | Procedure/Post-procedure | Date) Pain requiring prescription medication (Yes/No | Procedure/Post-procedure | Date) | Deep placement of implant (Yes/No | Procedure/Post-procedure | Date) Other Infection (Yes/No | Procedure/Post-procedure | Date) Fainting or dizziness (Yes/No | Procedure/Post-procedure | Date) Surgical hemorrhage (Yes/No) Other medical product related AE (Yes/No | Procedure/Post-procedure | Date) If yes, specify Other procedure related AE (Yes/No | Procedure/Post-procedure | Date) If yes, specify |
Events or Complications - LARC – Intrauterine Devices (18) | Hematoma formation (Yes/No | Procedure/Post-procedure | Date) Device expulsion (Yes/No | Procedure/Post-procedure | Date) Device malposition/migration/dislocation (Yes/No | Procedure/Post-procedure | Date) Nerve injury (Yes/No | Procedure/Post-procedure | Date) Visceral organ injury (Yes/No | Procedure/Post-procedure | Date) Perforation (Yes/No | Procedure/Post-procedure | Date | Specify Organ perforated) Vascular injury (Yes/No | Procedure/Post-procedure | Date) Venous thrombosis within 30 days of procedure (Yes/No | Procedure/Post-procedure | Date) Pain requiring prescription medication (Yes/No | Procedure/Post-procedure | Date) | Vasovagal syncope or seizure on day of placement (Yes/No | Procedure/Post-procedure | Date) Pelvic inflammatory disease (PID) (Yes/No | Procedure/Post-procedure | Date) Other Infection (Yes/No | Procedure/Post-procedure | Date) Nausea or vomiting (Yes/No | Procedure/Post-procedure | Date) Fainting or dizziness (Yes/No | Procedure/Post-procedure | Date) Other medical product related AE (Yes/No | Procedure/Post-procedure | Date) If yes, specify Other procedure related AE (Yes/No | Procedure/Post-procedure | Date) If yes, specify |
Pregnancy (20) | Date of confirmation of pregnancy Gestational age at presentation (in weeks) Estimated due date (relatively easy to calculate and can be done at the time of presentation) Pregnancy outcome: Ectopic (Y/N)
Intrauterine (Y/N) (if yes, provide date)
| Termination of pregnancy
Miscarriage/fetal demise (e.g. Intra Uterine Fetal Death (IUFD)
Other abnormal pregnancy (e.g. molar)
Delivery
|
Methods for Evaluations of Endpoints (2) | Did event meet criteria for a serious adverse event? (Y/N - Criteria: Death; Life-Threatening; Hospitalization Required; Prolonged hospitalization; Congenital Anomaly or birth defect; Persistent Disability or Incapacity) | Outcome of Treatment of AE (e.g., Recovered, Recovered with Unresolved Sequelae, etc.) |