Contraception
Conditions
Brief summary
The purpose of this study is to compare the safety of performing a bilateral tubal ligation vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the time of cesarean delivery. The investigators want to determine if performing bilateral salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as compared to a bilateral tubal ligation.
Detailed description
A non-inferiority, two-arm randomized controlled trial to evaluate the safety and feasibility of prophylactic salpingectomy at the time of a cesarean delivery will be conducted as an initiative to avoid a missed opportunity in the primary prevention of ovarian cancer. Once enrolled and consented, women will be randomized using a stratified block randomization algorithm according to number of prior cesarean deliveries and BMI to either salpingectomy or bilateral tubal ligation. The data collection will include preoperative CBC, time of procedure, postoperative CBC at 24 hours, standard patient demographics, procedural complications, estimated blood loss, return to the OR, length of stay, pain scores, and postoperative complications, including readmission within 6 weeks.
Interventions
PROCEDUREBilateral Salpingectomy
Surgical removal of entire fallopian tubes
PROCEDUREBilateral Tubal Ligation
Surgical tying, cutting, or removal of a portion of the fallopian tubes
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women * 21 years of age or older * Desire permanent sterilization * Scheduled for a Cesarean delivery
Exclusion criteria
* Body Mass Index \> 50 * Emergent, 'alpha' Cesarean delivery * Single ovary/fallopian tube complex
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference Between Pre and Postoperative Hemoglobin (g/dl) | At least 24 but not greater than 48 hours after surgery | Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Day of surgery | Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery. |
| Estimated Blood Loss | Day of surgery | Identify mean difference in estimated total blood loss as a result of standard bilateral tubal ligation surgical procedure and bilateral salpingectomy procedure, following cesarean delivery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Salpingectomy Bilateral salpingectomy following cesarean delivery
Bilateral Salpingectomy: Surgical removal of entire fallopian tubes | 18 |
| Tubal Ligation Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.
Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes | 20 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Surgeon not available | 2 | 0 |
Baseline characteristics
| Characteristic | Salpingectomy | Total | Tubal Ligation |
|---|---|---|---|
| Age, Continuous | 32.7 years STANDARD_DEVIATION 4.8 | 33.6 years STANDARD_DEVIATION 4.4 | 34.4 years STANDARD_DEVIATION 4.1 |
| Education 4 year or professional degree | 5 Participants | 17 Participants | 12 Participants |
| Education High school or some High School | 2 Participants | 4 Participants | 2 Participants |
| Education Missing | 0 Participants | 1 Participants | 1 Participants |
| Education Some College | 11 Participants | 16 Participants | 5 Participants |
| Gestational Age | 38.0 weeks STANDARD_DEVIATION 2.4 | 37.8 weeks STANDARD_DEVIATION 2.5 | 37.6 weeks STANDARD_DEVIATION 2.6 |
| Gravity | 3 Pregnancies | 4 Pregnancies | 4 Pregnancies |
| Parity | 1.5 viable pregnancies | 2 viable pregnancies | 2 viable pregnancies |
| Race/Ethnicity, Customized Race Hispanic and/or Latino | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 17 Participants | 37 Participants | 20 Participants |
| Region of Enrollment United States | 18 participants | 38 participants | 20 participants |
| Repeat Cesarean First Cesarean | 2 Participants | 5 Participants | 3 Participants |
| Repeat Cesarean Repeat Cesarean | 16 Participants | 33 Participants | 17 Participants |
| Sex: Female, Male Female | 18 Participants | 38 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking Status Current | 5 Participants | 8 Participants | 3 Participants |
| Smoking Status Former | 1 Participants | 8 Participants | 7 Participants |
| Smoking Status Never | 12 Participants | 22 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 20 |
| other Total, other adverse events | 1 / 18 | 2 / 20 |
| serious Total, serious adverse events | 3 / 18 | 0 / 20 |
Outcome results
Primary
Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)
Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery.
Time frame: At least 24 but not greater than 48 hours after surgery
Population: One patient in the Salpingectomy group is was missing post operation hemoglobin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Salpingectomy | Mean Difference Between Pre and Postoperative Hemoglobin (g/dl) | 1.4 g/dL | Standard Deviation 0.7 |
| Tubal Ligation | Mean Difference Between Pre and Postoperative Hemoglobin (g/dl) | 1.8 g/dL | Standard Deviation 1 |
Comparison: Assuming that a difference of 0.5 g/dl in the drop in hemoglobin between study arms would be considered as equivalent, and assuming a common standard deviation of 1.1 based on previous studies of cesarean deliveries deliveries , the study would have 80% power to test for non-inferiority with 60 participants in each arm (120 total).p-value: 0.08t-test, 1 sided
Secondary
Estimated Blood Loss
Identify mean difference in estimated total blood loss as a result of standard bilateral tubal ligation surgical procedure and bilateral salpingectomy procedure, following cesarean delivery.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Salpingectomy | Estimated Blood Loss | 842 mL | Standard Deviation 84.5 |
| Tubal Ligation | Estimated Blood Loss | 833 mL | Standard Deviation 105.5 |
Comparison: Analysis preformed as categorical and categorical variable. Both analyzes had the same conclusion.p-value: 0.7795% CI: [-72.5, 54.17]t-test, 2 sided
Secondary
Operative Time
Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Salpingectomy | Operative Time | 16.3 mins | Standard Deviation 5.6 |
| Tubal Ligation | Operative Time | 5.1 mins | Standard Deviation 1.6 |
95% CI: [-14.1, -8.3]