Obstetrics and gynecology · 2019
Expedited Scheduling of Interval Tubal Ligation: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Mercier Rebecca J, Perriera Lisa, Godcharles Cheryl, Shaber Allison
Аннотация
OBJECTIVE: To assess whether expedited scheduling for permanent contraception increases the proportion of patients completing interval tubal ligation within 6 months of delivery.
METHODS: We randomly assigned patients with unfulfilled immediate postpartum tubal ligation requests to standard scheduling after a postpartum office visit or an expedited process in which we scheduled the interval tubal ligation surgery before discharge from the hospital. The primary outcome was proportion of participants undergoing tubal contraceptive procedures within 6 months of delivery. Secondary outcomes included patient satisfaction with the scheduling process, repeat pregnancy rates, and surgical outcomes. We estimated that 122 patients (61 per group) would provide greater than 80% power to identify a 25% difference favoring expedited scheduling in the primary outcome (one-sided α of 0.05).
RESULTS: Between September 2016 and June 2018, 239 patients requested tubal ligation at the time of delivery; 155 were not completed. Of these, 126 patients were eligible for the study. We stopped the study at the prespecified 50% enrollment point after 67 patients enrolled, with 34 and 33 assigned to the standard and expedited arms, respectively. Fifteen participants in the expedited group, and two in the standard group completed tubal ligation within 6 months (50% vs 9%; odds ratio 10.0, CI 2.0-50.2). Delivery-to-surgery interval was 49 days in the expedited group, compared with 121 days in the standard group (P=.05). Seventeen participants in the expedited group and three in the standard group reported being very satisfied with the scheduling process (57% vs 13%, P=.03). The only two interim pregnancies both occurred in the standard group (P=.09). There were no surgical complications in any of the 17 completed tubal procedures.
CONCLUSION: Expedited scheduling significantly improves tubal contraceptive surgery completion and patient satisfaction. Laparoscopic or hysteroscopic tubal ligation or salpingectomy can be performed 4-6 weeks after delivery with minimal interval outpatient follow-up.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02875483.
METHODS: We randomly assigned patients with unfulfilled immediate postpartum tubal ligation requests to standard scheduling after a postpartum office visit or an expedited process in which we scheduled the interval tubal ligation surgery before discharge from the hospital. The primary outcome was proportion of participants undergoing tubal contraceptive procedures within 6 months of delivery. Secondary outcomes included patient satisfaction with the scheduling process, repeat pregnancy rates, and surgical outcomes. We estimated that 122 patients (61 per group) would provide greater than 80% power to identify a 25% difference favoring expedited scheduling in the primary outcome (one-sided α of 0.05).
RESULTS: Between September 2016 and June 2018, 239 patients requested tubal ligation at the time of delivery; 155 were not completed. Of these, 126 patients were eligible for the study. We stopped the study at the prespecified 50% enrollment point after 67 patients enrolled, with 34 and 33 assigned to the standard and expedited arms, respectively. Fifteen participants in the expedited group, and two in the standard group completed tubal ligation within 6 months (50% vs 9%; odds ratio 10.0, CI 2.0-50.2). Delivery-to-surgery interval was 49 days in the expedited group, compared with 121 days in the standard group (P=.05). Seventeen participants in the expedited group and three in the standard group reported being very satisfied with the scheduling process (57% vs 13%, P=.03). The only two interim pregnancies both occurred in the standard group (P=.09). There were no surgical complications in any of the 17 completed tubal procedures.
CONCLUSION: Expedited scheduling significantly improves tubal contraceptive surgery completion and patient satisfaction. Laparoscopic or hysteroscopic tubal ligation or salpingectomy can be performed 4-6 weeks after delivery with minimal interval outpatient follow-up.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02875483.