Objective
To evaluate 17-alpha hydroxyprogesterone caproate (17P) for prevention of preterm birth (PTB) in women with prior spontaneous PTB (SPTB) and cervical length (CL) <25mm.
Study Design
Planned secondary analysis of the NICHD-sponsored randomized trial evaluating cerclage for women with singleton gestations, prior SPTB (17-33 6/7weeks), and CL<25mm between 16-22 6/7weeks. Women were stratified at randomization to intent to use or not use 17P. The effect of 17P was analyzed separately for cerclage and no cerclage groups. Primary outcome was PTB<35weeks.
Results
In 300 women, 17P had no effect on PTB<35weeks in either cerclage (p=0.64) or no cerclage (p=0.51) groups. Only PTB<24weeks (OR=0.08) and perinatal death (OR=0.14) were significantly lower for those with 17P in the no cerclage group.
Conclusions
17P had no additional benefit for prevention of PTB in women who have prior spontaneous PTB and get ultrasound-indicated cerclage for CL<25mm. In women who do not get cerclage, 17P reduced previable birth and perinatal mortality.
Objective
To compare the risk of cesarean wound disruption or infection after closure with surgical staples compared with subcuticular suture.
Methods
Women with viable pregnancies at 24 weeks of gestation or greater undergoing scheduled or unscheduled cesarean delivery were randomized to wound closure with surgical staples or absorbable suture. Staples were removed at postoperative days 3-4 for low transverse incisions and days 7-10 for vertical incisions. Standardized wound evaluations were performed at discharge (days 3-4) and 4-6 weeks post-operatively. The primary outcome was a composite of wound disruption or infection within 4-6 weeks. Secondary outcomes included operative time, highest pain score on analog scale, cosmesis score and patient scar satisfaction score. Analyses were by intent-to-treat.
Results
Of 398 patients, 198 were randomized to staples and 200 to suture (but four received staples). Baseline characteristics including body mass index, prior cesarean, labor, and type of skin incision were similar by group. The primary outcome incidence at hospital discharge was 7.1% for staples and 0.5% for suture; P <0.001 (RR 14.1; 95% CI 1.9-106). Of 350 (87.9%) with follow up at 4-6 weeks, the cumulative risk of the primary outcome at 4-6 weeks was 14.5% for staples and 5.9% for suture; P=0.008 (RR 2.5; 95% CI 1.2-5.0). Operative time, pain scores at 72-96 hours and at 6 weeks, cosmesis score, and patient satisfaction score did not differ by group.
Conclusion
Staples closure compared with suture is associated with significantly increased composite wound morbidity after cesarean delivery.
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