Maternal and Neonatal Outcomes in Nulliparous Participants Undergoing Labor Induction by Cervical Ripening Method

Maria Andrikopoulou; Elisa T. Bushman; Madeline M. Rice; William A. Grobman; Uma M. Reddy; Robert M. Silver; Yasser Y. El-Sayed; Dwight J. Rouse; George R. Saade; John M. Thorp Jr.; Suneet P. Chauhan; Maged M. Costantine; Edward K. Chien; Brian M. Casey; Sindhu K. Srinivas; Geeta K. Swamy; Hyagriv N. Simhan; for the Eunice Kennedy Shriver National Institute of Child Health Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network

doi:10.1055/s-0041-1732379

American Journal of Perinatology, Inhaltsverzeichnis

Am J Perinatol 2023; 40(10): 1061-1070
DOI: 10.1055/s-0041-1732379

Original Article

Maternal and Neonatal Outcomes in Nulliparous Participants Undergoing Labor Induction by Cervical Ripening Method

Maria Andrikopoulou

¹Department of Obstetrics and Gynecology, Columbia University, New York, New York

,

Elisa T. Bushman

²Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama

,

Madeline M. Rice

³The George Washington University Biostatistics Center, Washington, District of Columbia

,

William A. Grobman

⁴Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois

,

Uma M. Reddy

⁵The Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland

,

Robert M. Silver

⁶Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah

,

Yasser Y. El-Sayed

⁷Department of Obstetrics and Gynecology, Stanford University, Stanford, California

,

Dwight J. Rouse

⁸Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island

,

George R. Saade

⁹Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas

,

John M. Thorp Jr.

¹⁰Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

,

Suneet P. Chauhan

¹¹Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas

,

Maged M. Costantine

¹²Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio

,

Edward K. Chien

¹³Department of Obstetrics and Gynecology, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio

,

Brian M. Casey

¹⁴Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas

,

Sindhu K. Srinivas

¹⁵Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania

,

Geeta K. Swamy

¹⁶Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina

,

Hyagriv N. Simhan

¹⁷Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania

,

for the Eunice Kennedy Shriver National Institute of Child Health Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network

› Institutsangaben

Abstract

Objective This study aimed to evaluate maternal and neonatal outcomes by method of cervical ripening for labor induction among low-risk nulliparous individuals.

Study Design This is a secondary analysis of a multicenter randomized trial of labor induction at 39 weeks versus expectant management in low-risk nulliparous participants. Participants undergoing cervical ripening for labor induction in either group were included. Participants were excluded for preripening membrane rupture, abruption, chorioamnionitis, fetal demise, or cervical dilation ≥3.5 cm. Cervical ripening was defined by the initial method used: prostaglandin only (PGE; referent), Foley with concurrent prostaglandin (Foley-PGE), Foley only (Foley), and Foley with concurrent oxytocin (Foley-oxytocin). Coprimary outcomes were adverse maternal and neonatal composites. Secondary outcomes included cesarean delivery and length of labor and delivery (L&D) stay. Multivariable analysis was used to adjust for patient characteristics.

Results Of 6,106 participants included in the trial, 2,376 (38.9%) met criteria for this analysis. Of these, 1,247 (52.4%) had cervical ripening with PGE, 290 (12.2%) had Foley-PGE, 385 (16.2%) had Foley, and 454 (19.1%) had Foley-oxytocin. The maternal composite outcome was similar among participants who received Foley-PGE (24.1%, adjusted relative risk [aRR] = 1.21, 95% confidence interval [CI]: 0.96–1.52), Foley (21.3%, aRR = 1.16, 95% CI: 0.92–1.45), or Foley-oxytocin (19.4%, aRR = 1.04, 95% CI: 0.83–1.29), compared with PGE (19.7%). The neonatal composite outcome was less frequent in participants who received the Foley-PGE (2.4%, aRR = 0.35, 95% CI: 0.16–0.75) or Foley (3.6%, aRR = 0.51, 95% CI: 0.29–0.89) but did not reach statistical significance for participants who received Foley-oxytocin (4.6%, aRR = 0.63, 95% CI: 0.40–1.01) compared with PGE only (6.8%). Participants who received Foley-PGE or Foley-oxytocin had a shorter L&D stay (adjusted mean difference = −1.97 hours, 95% CI: −3.45 to −0.49 and −5.92 hours, 95% CI: −7.07 to −4.77, respectively), compared with PGE.

Conclusion In term low-risk nulliparous participants, Foley alone or concurrent with PGE is associated with a lower risk of adverse neonatal outcomes than with PGE alone. Length of L&D stay was the shortest with concurrent Foley-oxytocin.

Key Points

Adverse maternal outcomes are similar among different methods of cervical ripening in low-risk women.
Adverse neonatal outcomes are less frequent with use of Foley alone or in combination with PGE.
The use of Foley alone, or in combination with other agents, appears to be beneficial.

Keywords

induction methods - prostaglandin - Foley - oxytocin - nulliparous

Volltext

Referenzen

References
1 Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2011. Natl Vital Stat Rep 2013; 62 (01) 1-69 , 72
2 Grobman WA, Rice MM, Reddy UM. et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med 2018; 379 (06) 513-523
3 Chen W, Xue J, Peprah MK. et al. A systematic review and network meta-analysis comparing the use of Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of labour. BJOG 2016; 123 (03) 346-354
4 Al-Ibraheemi Z, Brustman L, Bimson BE, Porat N, Rosenn B. Misoprostol with Foley bulb compared with misoprostol alone for cervical ripening: a randomized controlled trial. Obstet Gynecol 2018; 131 (01) 23-29
5 Bauer AM, Lappen JR, Gecsi KS, Hackney DN. Cervical ripening balloon with and without oxytocin in multiparas: a randomized controlled trial. Am J Obstet Gynecol 2018; 219 (03) 294.e1-294.e6
6 Kramer RL, Gilson GJ, Morrison DS, Martin D, Gonzales JL, Qualls CR. A randomized trial of misoprostol and oxytocin for induction of labor: safety and efficacy. Obstet Gynecol 1997; 89 (03) 387-391
7 Wing DA, Ortiz-Omphroy G, Paul RH. A comparison of intermittent vaginal administration of misoprostol with continuous dinoprostone for cervical ripening and labor induction. Am J Obstet Gynecol 1997; 177 (03) 612-618
8 Abramovici D, Goldwasser S, Mabie BC, Mercer BM, Goldwasser R, Sibai BM. A randomized comparison of oral misoprostol versus Foley catheter and oxytocin for induction of labor at term. Am J Obstet Gynecol 1999; 181 (5, pt 1): 1108-1112
9 Garry D, Figueroa R, Kalish RB, Catalano CJ, Maulik D. Randomized controlled trial of vaginal misoprostol versus dinoprostone vaginal insert for labor induction. J Matern Fetal Neonatal Med 2003; 13 (04) 254-259
10 de Aquino MM, Cecatti JG. Misoprostol versus oxytocin for labor induction in term and post-term pregnancy: randomized controlled trial. Sao Paulo Med J 2003; 121 (03) 102-106
11 Nigam A, Singh VK, Dubay P, Pandey K, Bhagoliwal A, Prakash A. Misoprostol vs. oxytocin for induction of labor at term. Int J Gynaecol Obstet 2004; 86 (03) 398-400
12 Wing DA, Fassett MJ, Guberman C, Tran S, Parrish A, Guinn D. A comparison of orally administered misoprostol to intravenous oxytocin for labor induction in women with favorable cervical examinations. Am J Obstet Gynecol 2004; 190 (06) 1689-1694 , discussion 1694–1696
13 Fonseca L, Wood HC, Lucas MJ. et al. Randomized trial of preinduction cervical ripening: misoprostol vs oxytocin. Am J Obstet Gynecol 2008; 199 (03) 305.e1-305.e5
14 Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol 2008; 111 (06) 1320-1326
15 Aalami-Harandi R, Karamali M, Moeini A. Induction of labor with titrated oral misoprostol solution versus oxytocin in term pregnancy: randomized controlled trial. Rev Bras Ginecol Obstet 2013; 35 (02) 60-65
16 Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Stat Soc B 1995; 57: 289-300
17 Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev 2012; (03) CD001233
18 Vaknin Z, Kurzweil Y, Sherman D. Foley catheter balloon vs locally applied prostaglandins for cervical ripening and labor induction: a systematic review and metaanalysis. Am J Obstet Gynecol 2010; 203 (05) 418-429
19 Fox NS, Saltzman DH, Roman AS, Klauser CK, Moshier E, Rebarber A. Intravaginal misoprostol versus Foley catheter for labour induction: a meta-analysis. BJOG 2011; 118 (06) 647-654
20 Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and pharmacologic methods of labor induction: a randomized controlled trial. Obstet Gynecol 2016; 128 (06) 1357-1364
21 Sciscione AC, McCullough H, Manley JS, Shlossman PA, Pollock M, Colmorgen GH. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Am J Obstet Gynecol 1999; 180 (1, pt 1): 55-60
22 Jonsson M, Hellgren C, Wiberg-Itzel E, Akerud H. Assessment of pain in women randomly allocated to speculum or digital insertion of the Foley catheter for induction of labor. Acta Obstet Gynecol Scand 2011; 90 (09) 997-1004
23 Maslovitz S, Lessing JB, Many A. Complications of trans-cervical Foley catheter for labor induction among 1,083 women. Arch Gynecol Obstet 2010; 281 (03) 473-477
24 Henry A, Madan A, Reid R. et al. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth 2013; 13 (01) 25

Zusatzmaterial

Supplementary Material