Cervical Pessary versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women with Placenta Previa: A Randomized Controlled Trial

Irene A. Stafford; Thomas J. Garite; Kimberly Maurel; C. Andrew Combs; Kent Heyborne; Richard Porreco; Michael Nageotte; Susan Baker; Sameer Gopalani; Chi Dola; Helen How; Anita F. Das; the Obstetrix Collaborative Research Network

doi:10.1055/s-0039-1687871

American Journal of Perinatology Reports, Inhaltsverzeichnis

CC BY-NC-ND 4.0 · AJP Rep 2019; 09(02): e160-e166
DOI: 10.1055/s-0039-1687871

Original Article

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Cervical Pessary versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women with Placenta Previa: A Randomized Controlled Trial

Irene A. Stafford

¹Department of Obstetrics and Gynecology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas

²Touro Infirmary, Louisiana State University Health Science Center, New Orleans, Louisiana

,

Thomas J. Garite

³University of California, Irvine, Orange, California

⁴The Center for Research, Education, Quality and Safety, Mednax, Inc., Sunrise, Florida

,

Kimberly Maurel

⁴The Center for Research, Education, Quality and Safety, Mednax, Inc., Sunrise, Florida

,

C. Andrew Combs

⁴The Center for Research, Education, Quality and Safety, Mednax, Inc., Sunrise, Florida

⁵Obstetrix Medical Group, San Jose, California

,

Kent Heyborne

⁶Denver Health and Hospital Authority, Denver, Colorado

,

Richard Porreco

⁷Obstetrix Medical Group of Colorado, Denver, Colorado

,

Michael Nageotte

⁸Long Beach Memorial Medical Center, Long Beach, California

,

Susan Baker

⁹University of South Alabama Children's and Women's Hospital, Mobile, Alabama

,

Sameer Gopalani

¹⁰Obstetrix Medical Group of Washington, Seattle, Washington

,

Chi Dola

¹¹Tulane Lakeside Hospital for Women and Children, New Orleans, Louisiana

,

Helen How

¹²Norton Hospital, Louisville, Kentucky

,

Anita F. Das

¹³Das Consulting Group, San Francisco, California

,

the Obstetrix Collaborative Research Network

› Institutsangaben

Abstract

Objective This multicenter randomized controlled trial compared cervical pessary (CP) versus expectant management (EM) in women with placenta previa between 22.0 and 32.0 in prolonging gestation until ≥ 36.0 weeks' gestation.

Study Design This study took place from November 2016 to June 2018. Women were randomized to receive either the Bioteque CP or EM. The pessary was removed at ≥ 36.0 weeks unless indicated. The primary outcome was gestational age (GA) at delivery, with secondary outcomes including need for transfusion, number and duration of antepartum admissions, type of delivery, and neonatal outcomes. A total of 140 patients were needed to show a 3-week prolongation of pregnancy in the pessary group; however, the trial was stopped early due to budgetary issues.

Results Of the 33 eligible women, 17 were enrolled. Although not statistically significant, the mean GA at delivery in the CP group was greater than women in the EM group (36.5 ± 1.23 vs. 36.0 ± 2.0; p = 0.1673). The number and duration of antepartum admissions was greater in the EM group (2.7 ± 0.58 vs. 16.0 ± 22.76 days; p = 0.1264) as well.

Conclusion Although the study was underpowered to determine the primary outcome, safety and feasibility of CP in pregnancies complicated with previa were demonstrated.

Keywords

placenta previa - pessary - hemorrhage - preterm birth

Volltext

Referenzen

References
1 Silver RM. Abnormal placentation: placenta previa, vasa previa, and placenta accreta. Obstet Gynecol 2015; 126 (03) 654-668
2 Iyasu S, Saftlas AK, Rowley DL, Koonin LM, Lawson HW, Atrash HK. The epidemiology of placenta previa in the United States, 1979 through 1987. Am J Obstet Gynecol 1993; 168 (05) 1424-1429
3 Cresswell JA, Ronsmans C, Calvert C, Filippi V. Prevalence of placenta praevia by world region: a systematic review and meta-analysis. Trop Med Int Health 2013; 18 (06) 712-724
4 Getahun D, Oyelese Y, Salihu HM, Ananth CV. Previous cesarean delivery and risks of placenta previa and placental abruption. Obstet Gynecol 2006; 107 (04) 771-778
5 Ananth CV, Smulian JC, Vintzileos AM. The association of placenta previa with history of cesarean delivery and abortion: a metaanalysis. Am J Obstet Gynecol 1997; 177 (05) 1071-1078
6 Ananth CV, Wilcox AJ, Savitz DA, Bowes Jr WA, Luther ER. Effect of maternal age and parity on the risk of uteroplacental bleeding disorders in pregnancy. Obstet Gynecol 1996; 88 (4 Pt 1): 511-516
7 Macones GA, Sehdev HM, Parry S, Morgan MA, Berlin JA. The association between maternal cocaine use and placenta previa. Am J Obstet Gynecol 1997; 177 (05) 1097-1100
8 Ananth CV, Demissie K, Smulian JC, Vintzileos AM. Placenta previa in singleton and twin births in the United States, 1989 through 1998: a comparison of risk factor profiles and associated conditions. Am J Obstet Gynecol 2003; 188 (01) 275-281
9 Crane JM, Van den Hof MC, Dodds L, Armson BA, Liston R. Maternal complications with placenta previa. Am J Perinatol 2000; 17 (02) 101-105
10 Grobman WA, Gersnoviez R, Landon MB. , et al; National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Pregnancy outcomes for women with placenta previa in relation to the number of prior cesarean deliveries. Obstet Gynecol 2007; 110 (06) 1249-1255
11 Iams JD, Goldenberg RL, Meis PJ. , et al; National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. The length of the cervix and the risk of spontaneous premature delivery. N Engl J Med 1996; 334 (09) 567-572
12 Goldenberg RL, Iams JD, Das A. , et al; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. The Preterm Prediction Study: sequential cervical length and fetal fibronectin testing for the prediction of spontaneous preterm birth. Am J Obstet Gynecol 2000; 182 (03) 636-643
13 Andrews WW, Copper R, Hauth JC, Goldenberg RL, Neely C, Dubard M. Second-trimester cervical ultrasound: associations with increased risk for recurrent early spontaneous delivery. Obstet Gynecol 2000; 95 (02) 222-226
14 Stafford IA, Dashe JS, Shivvers SA, Alexander JM, McIntire DD, Leveno KJ. Ultrasonographic cervical length and risk of hemorrhage in pregnancies with placenta previa. Obstet Gynecol 2010; 116 (03) 595-600
15 Berghella V, Odibo AO, To MS, Rust OA, Althuisius SM. Cerclage for short cervix on ultrasonography: meta-analysis of trials using individual patient-level data. Obstet Gynecol 2005; 106 (01) 181-189
16 Alfirevic Z, Stampalija T, Medley N. Cervical stitch (cerclage) for preventing preterm birth in singleton pregnancy. Cochrane Database Syst Rev 2017; 6: CD008991
17 Enakpene CA, DiGiovanni L, Jones TN, Marshalla M, Mastrogiannis D, Della Torre M. Cervical cerclage for singleton pregnant patients on vaginal progesterone with progressive cervical shortening. Am J Obstet Gynecol 2018; 219 (04) 397.e1-397.e10
18 Liu Y, Ke Z, Liao W. , et al. Pregnancy outcomes and superiorities of prophylactic cervical cerclage and therapeutic cervical cerclage in cervical insufficiency pregnant women. Arch Gynecol Obstet 2018; 297 (06) 1503-1508
19 Berghella V, Ciardulli A, Rust OA. , et al. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol 2017; 50 (05) 569-577
20 Arias F. Cervical cerclage for the temporary treatment of patients with placenta previa. Obstet Gynecol 1988; 71 (04) 545-548
21 Cobo E, Conde-Agudelo A, Delgado J, Canaval H, Congote A. Cervical cerclage: an alternative for the management of placenta previa?. Am J Obstet Gynecol 1998; 179 (01) 122-125
22 Jaswal A, Manaktala U, Sharma JB. Cervical cerclage in expectant management of placenta previa. Int J Gynaecol Obstet 2006; 93 (01) 51-52
23 Arabin B, Alfirevic Z. Cervical pessaries for prevention of spontaneous preterm birth: past, present and future. Ultrasound Obstet Gynecol 2013; 42 (04) 390-399
24 Goya M, Pratcorona L, Merced C. , et al; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet 2012; 379 (9828): 1800-1806
25 Hui SY, Chor CM, Lau TK, Lao TT, Leung TY. Cerclage pessary for preventing preterm birth in women with a singleton pregnancy and a short cervix at 20 to 24 weeks: a randomized controlled trial. Am J Perinatol 2013; 30 (04) 283-288
26 Nicolaides KH, Syngelaki A, Poon LC. , et al. A randomized trial of a cervical pessary to prevent preterm singleton birth. N Engl J Med 2016; 374 (11) 1044-1052
27 Saccone G, Ciardulli A, Xodo S. , et al. Cervical pessary for preventing preterm birth in twin pregnancies with short cervical length: a systematic review and meta-analysis. J Matern Fetal Neonatal Med 2017; 30 (24) 2918-2925
28 Nicolaides KH, Syngelaki A, Poon LC. , et al. Cervical pessary placement for prevention of preterm birth in unselected twin pregnancies: a randomized controlled trial. Am J Obstet Gynecol 2016; 214 (01) 3.e1-3.e9
29 Jarde A, Lutsiv O, Park CK. , et al. Preterm birth prevention in twin pregnancies with progesterone, pessary, or cerclage: a systematic review and meta-analysis. BJOG 2017; 124 (08) 1163-1173
30 Berghella V, Dugoff L, Ludmir J. Prevention of preterm birth with pessary in twins (PoPPT): a randomized controlled trial. Ultrasound Obstet Gynecol 2017; 49 (05) 567-572
31 Saccone G, Ciardulli A, Xodo S. , et al. Cervical pessary for preventing preterm birth in singleton pregnancies with short cervical length: a systematic review and meta-analysis. J Ultrasound Med 2017; 36 (08) 1535-1543
32 Barinov SV, Shamina IV, Di Renzo GC. , et al. The role of cervical pessary and progesterone therapy in the phenomenon of placenta previa migration. J Matern Fetal Neonatal Med 2018; •••: 1-11