Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial
Sarah C Lassey, Sarah E Little, Michael Saadeh, Nicole Patton, Michaela K Farber, Brian T Bateman, Julian N Robinson, Sarah C Lassey, Sarah E Little, Michael Saadeh, Nicole Patton, Michaela K Farber, Brian T Bateman, Julian N Robinson
Abstract
Objective: A cephalic elevation device is an inflatable device that elevates the fetal head. We sought to evaluate whether such a device reduces time to delivery after hysterotomy and lowers morbidity in cesarean deliveries during the second stage of labor.
Methods: We conducted a double-blind randomized controlled trial among nulliparous, term women aged 18-50 years with vertex singleton pregnancies. Women were eligible if they were to undergo cesarean delivery in the second stage of labor. All participating women had the cephalic elevation device inserted by the delivering provider and were randomly allocated to inflation or noninflation of the device. Inflation was performed in a blinded fashion. The primary outcome was time from hysterotomy to delivery. A sample size of 30 per group (N=60 participants) was planned to detect a 50% decrease in time to delivery after hysterotomy with cephalic elevation device inflation.
Results: From January 2018 through July 2019, 60 women who underwent cesarean delivery in the second stage were randomized. Analysis was by intention to treat. Women in the inflation group were older (33 vs 30.5 years), but the groups were otherwise similar. In both groups, most women had a low-transverse hysterotomy (93%). The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01). There was no significant difference in neonatal outcomes.
Conclusion: Use of the cephalic elevation device during second-stage cesarean delivery led to a 23-second reduction time from hysterotomy to delivery.
Clinical trial registration: ClinicalTrials.gov, NCT03342508.
Funding source: The cephalic elevation devices used in this study were donated by Safe Obstetrics Systems.
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References
- Mancuso MS, Rouse DJ. Cesarean delivery for abnormal labor. Clin Perinatol 2008;35:479–90, ix.
- Cohen WR. Influence of the duration of second stage labor on perinatal outcome and puerperal morbidity. Obstet Gynecol 1977;49:266–9.
- Myles TD, Santolaya J. Maternal and neonatal outcomes in patients with a prolonged second stage of labor. Obstet Gynecol 2003;102:52–8.
- Skajaa K, Hansen ES, Bendix J. Depressed fracture of the skull in a child born by cesarean section. Acta Obstet Gynecol Scand 1987;66:275–6.
- Saunders NG, Paterson CM, Wadsworth J. Neonatal and maternal morbidity in relation to the length of the second stage of labour. Br J Obstet Gynaecol 1992;99:381–5.
- Mufti N, Beaton L. Re-audit of the Fetal Pillow (FP): a novel intervention to reduce maternal and fetal complications at caesarean section at full dilation. BJOG 2015;122:48.
- Safa H, Beckmann M. Comparison of maternal and neonatal outcomes from full-dilation caesarean deliveries using the Fetal Pillow or hand push method. Int J Gynaecol Obstet 2016;135:281–4.
- Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J, Onwude JL. Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation. Int J Gynaecol Obstet 2016;133:178–82.
- Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J. Does elevating the fetal head prior to delivery using a fetal pillow reduce maternal and fetal complications in a full dilatation caesarean section? A prospective study with historical controls. J Obstet Gynaecol 2014;34:241–4.
- Rimsza RR, Perez WM, Babbar S, O'Brien M, Vricella LK. Time from neuraxial anesthesia placement to delivery is inversely proportional to umbilical arterial cord pH at scheduled cesarean delivery. Am J Obstet Gynecol 2019;220:389.e1–9.
Source: PubMed