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
1  Department of Obstetrics and Gynecology, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas
2  Touro Infirmary, Louisiana State University Health Science Center, New Orleans, Louisiana
,
Thomas J. Garite
3  University of California, Irvine, Orange, California
4  The Center for Research, Education, Quality and Safety, Mednax, Inc., Sunrise, Florida
,
Kimberly Maurel
4  The Center for Research, Education, Quality and Safety, Mednax, Inc., Sunrise, Florida
,
C. Andrew Combs
4  The Center for Research, Education, Quality and Safety, Mednax, Inc., Sunrise, Florida
5  Obstetrix Medical Group, San Jose, California
,
Kent Heyborne
6  Denver Health and Hospital Authority, Denver, Colorado
,
Richard Porreco
7  Obstetrix Medical Group of Colorado, Denver, Colorado
,
Michael Nageotte
8  Long Beach Memorial Medical Center, Long Beach, California
,
Susan Baker
9  University of South Alabama Children's and Women's Hospital, Mobile, Alabama
,
Sameer Gopalani
10  Obstetrix Medical Group of Washington, Seattle, Washington
,
Chi Dola
11  Tulane Lakeside Hospital for Women and Children, New Orleans, Louisiana
,
Helen How
12  Norton Hospital, Louisville, Kentucky
,
Anita F. Das
13  Das Consulting Group, San Francisco, California
,
the Obstetrix Collaborative Research Network› Author Affiliations
Further Information

Publication History

04 January 2019

21 February 2019

Publication Date:
30 April 2019 (online)

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.