Prevention of preterm birth with pessary in singletons (PoPPS): randomized controlled trial

Dugoff, Lorraine; Berghella, Vincenzo; Sehdev, Harish M.; Mackeen, A. Dhanya; Goetzl, Laura; Ludmir, Jack

doi:10.1002/uog.18908

Cited by 54 publications

(46 citation statements)

References 16 publications

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“…HIV serostatus has not been assessed as a cofactor in other studies of short cervix, likely because most have been performed in countries where HIV is rare. Prevalence estimates of short cervix have ranged between 1.7% and 2.4% in US and UK trials, compared with 3.3% in our study, although most other studies limit their data to cervical lengths assessed prior to 24 weeks of pregnancy. A higher prevalence of short cervix may also be explained at least partly by self‐selection of higher‐risk women into a prenatal cohort study whose aim is to investigate the predictors of PTB.…”

Section: Discussionmentioning

confidence: 99%

HIV serostatus, viral load, and midtrimester cervical length in a Zambian prenatal cohort

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Vwalika

Winston

et al. 2019

Intl J Gynecology & Obste

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Objective To evaluate whether maternal HIV serostatus and plasma viral load (VL) are associated with midtrimester cervical length (CL). Methods The Zambian Preterm Birth Prevention Study (ZAPPS) is an ongoing prospective cohort that began enrolling in Lusaka in August 2015. Pregnant women undergo ultrasound to determine gestational age and return for CL measurement at 16–28 weeks. We evaluated crude and adjusted associations between dichotomous indicators and short cervix (≤2.5 cm) via logistic regression, and between VL and CL as a continuous variable via linear regression. Results This analysis includes 1171 women enrolled between August 2015 and September 2017. Of 294 (25.1%) HIV‐positive women, 275 (93.5%) had viral load performed close to CL measurement; of these, 148 (53.8%) had undetectable virus. Median CL was 3.6 cm (IQR 3.5–4.0) and was similar in HIV‐infected (3.7 cm, IQR 3.5–4.0) versus uninfected (3.6 cm, IQR 3.5–4.0) participants (P=0.273). The odds of short CL were similar by HIV serostatus (OR 0.64; P=0.298) and detectable VL among those infected (OR 2.37, P=0.323). We observed no association between log VL and CL via linear regression (–0.12 cm; P=0.732). Conclusion We found no evidence of association between HIV infection and short CL.

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Section: Discussionmentioning

confidence: 99%

HIV serostatus, viral load, and midtrimester cervical length in a Zambian prenatal cohort

Price

Vwalika

Winston

et al. 2019

Intl J Gynecology & Obste

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“…This is a planned secondary analysis of the Prevention of Preterm birth with Pessary in Singletons trial (PoPPS trial) which was aimed to determine if pessary use prevents preterm birth in singleton gestations with a short TVU CL and without a prior spontaneous preterm birth . The parent trial was Institutional Review Board approved and only de‐identified data were used in this secondary analysis.…”

Section: Methodsmentioning

confidence: 99%

“…After randomization the women involved in the study underwent a physical manual cervical exam to assess the Bishop score from which cervical dilation was assessed for this secondary analysis. As part of the Bishop score, cervical dilation of the internal os was assigned a value 0‐2, with 0 = closed, 1 = 1‐2 cm dilated, and 2 = 3‐4 cm dilated . Physical exam was performed by selected investigators trained in pessary placement and standardized reporting of cervical exam; examiners were not blinded to the CL result and exam was performed after ultrasound and prior to any treatment initiation.…”

Section: Methodsmentioning

confidence: 99%

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Predicting asymptomatic cervical dilation in pregnant patients with short mid‐trimester cervical length: A secondary analysis of a randomized controlled trial

Boelig

Dugoff

Roman

et al. 2019

Acta Obstet Gynecol Scand

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Introduction: Second trimester asymptomatic cervical dilation is a significant risk factor for early preterm birth. The objective of this study is to evaluate whether transvaginal ultrasound cervical length (CL) predicts asymptomatic cervical dilation on physical exam in women with short cervix (CL ≤25 mm) and no prior preterm birth.Material and methods: Secondary analysis of a randomized trial on pessary in asymptomatic singletons without prior preterm birth diagnosed with CL ≤25 mm between 18 +0/7 and 23 +6/7 weeks. Participants had transvaginal ultrasound and physical cervical exam and were randomized to pessary or no pessary with all patients with cervical length ≤20 mm offered vaginal progesterone. The primary outcome was to determine whether CL was predictive of asymptomatic physical cervical dilation ≥1 cm using receiver operating characteristic curve. Results:In all, 119 women were included. Based on receiver operating characteristic curve, CL ≤11 mm was best predictive of cervical dilation ≥1 cm, with 75% sensitivity, 80% specificity, and area under the curve 0.73 (0.55-0.91), P = 0.009. Cervical length ≤11 mm had increased incidence of cervical dilation ≥1 cm on physical exam (30% vs 3%, odds ratio 12.29 (3.05-49.37) P < 0.001) with a negative predictive value of 97%. Patients with ≥1 cm dilation had increased preterm birth <37 weeks (75% vs 39%, P = 0.03) compared to those not dilated. Women with a CL ≤11 mm had increased preterm birth <37 weeks (77% vs 31%, P < 0.001), preterm birth <34 weeks (63% vs 22%, P < 0.001), and lower birthweight (1552 ± 1047 vs 2560 ± 1072 g, P < 0.001) compared to women with CL >11 mm.Conclusions: Among singletons without prior preterm birth diagnosed with short cervix (≤25 mm), CL ≤11 mm may identify a subgroup of patients at high risk for asymptomatic cervical dilation and poor perinatal outcome. Physical exam should be considered and adjunctive preterm birth prevention measures should be studied in singletons with CL ≤11 mm. K E Y W O R D Sadvanced cervical dilation, cervical length, preterm birth, short cervix, transvaginal ultrasound

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“…Another study in this issue considers the value of pessary placement in low-risk singleton pregnancy (without prior preterm birth). In 122 women with cervical length < 20 mm, those who received a pessary were no more likely to deliver preterm than were those who did not (43% vs 40%; relative risk, 1.09 (95% CI, 0.71-1.68)) 7 . This study confirms that women with a short cervix are at high risk of early delivery but is at variance with other recent low-risk studies suggesting substantial benefit of pessary use 8 .…”

Section: An Economic Evaluation In This Issue Demonstrates Cost Savmentioning

confidence: 97%

Prediction and prevention of preterm birth: a quagmire of evidence

Shennan

2018

Ultrasound in Obstet & Gyne

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Prevention of preterm birth with pessary in singletons (PoPPS): randomized controlled trial

Abstract: Cervical pessary use was not associated with prevention of PTB in women with a singleton pregnancy, short CL on TVS and no prior sPTB in this small, underpowered randomized controlled trial. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Cited by 54 publications

References 16 publications

HIV serostatus, viral load, and midtrimester cervical length in a Zambian prenatal cohort

HIV serostatus, viral load, and midtrimester cervical length in a Zambian prenatal cohort

Predicting asymptomatic cervical dilation in pregnant patients with short mid‐trimester cervical length: A secondary analysis of a randomized controlled trial

Prediction and prevention of preterm birth: a quagmire of evidence

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