Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/19/2018 |
| Start Date: | May 17, 2017 |
| End Date: | October 30, 2019 |
Opportunistic Salpingectomy at the Time of Cesarean Delivery: A Randomized Controlled Trial of the Safety of Salpingectomy vs Tubal Ligation
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.
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.
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.
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.
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
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