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Randomized Controlled Trial
. 2024 Sep 6:46:e-rbgo39i.
doi: 10.61622/rbgo/2024rbgo39i. eCollection 2024.

A new screening of preterm birth in gestation with short cervix after pessary plus progesterone

Marcelo Santucci França  1 , Valter Lacerda de Andrade Jr  2 , Alan Roberto Hatanaka  1 , Roberto Santos  2 , Francisco Herlanio Costa Carvalho  3 , Maria Laura Costa  4 , Gabriela Ubeda Santucci França  1 , Rosiane Mattar  1 , Ben Willem Mol  5 , Antonio Fernandes Moron  1 , Rodolfo de Carvalho Pacagnella  3
Affiliations
Randomized Controlled Trial

A new screening of preterm birth in gestation with short cervix after pessary plus progesterone

Marcelo Santucci França et al. Rev Bras Ginecol Obstet. .

Abstract

Objective: This study aims to create a new screening for preterm birth < 34 weeks after gestation with a cervical length (CL) ≤ 30 mm, based on clinical, demographic, and sonographic characteristics.

Methods: This is a post hoc analysis of a randomized clinical trial (RCT), which included pregnancies, in middle-gestation, screened with transvaginal ultrasound. After observing inclusion criteria, the patient was invited to compare pessary plus progesterone (PP) versus progesterone only (P) (1:1). The objective was to determine which variables were associated with severe preterm birth using logistic regression (LR). The area under the curve (AUC), sensitivity, specificity, and positive predictive value (PPV) and negative predictive value (NPV) were calculated for both groups after applying LR, with a false positive rate (FPR) set at 10%.

Results: The RCT included 936 patients, 475 in PP and 461 in P. The LR selected: ethnics white, absence of previous curettage, previous preterm birth, singleton gestation, precocious identification of short cervix, CL < 14.7 mm, CL in curve > 21.0 mm. The AUC (CI95%), sensitivity, specificity, PPV, and PNV, with 10% of FPR, were respectively 0.978 (0.961-0.995), 83.4%, 98.1%, 83.4% and 98.1% for PP < 34 weeks; and 0.765 (0.665-0.864), 38.7%, 92.1%, 26.1% and 95.4%, for P < 28 weeks.

Conclusion: Logistic regression can be effective to screen preterm birth < 34 weeks in patients in the PP Group and all pregnancies with CL ≤ 30 mm.

Keywords: Cervix uteri; Logistic models; Pessaries; Preterm birth; Progesterone; Screening; Ultrasonography.

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Conflict of interest statement

Conflicts to interest: none to declare.

Figures

Figure 1
Figure 1. Patient selection process
Figure 2
Figure 2. ROC curve of Logistic Regression and Cervical length< 15 mm (Group PP) targeting preterm birth < 34
Figure 3
Figure 3. ROC curves of Logistic Regression for preterm birth < 34 weeks (left) and preterm birth and perinatal death < 28 weeks (right) in the Progesterone Group
See this image and copyright information in PMC

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