Transvaginal cervical length scans to prevent prematurity in twins: a randomized controlled trial

Objective: To compare the obstetrics and neonatal outcome of a protocol using the cervical length (CL) measurement with a traditional protocol without CL measurement in the management of threatened preterm labor. Materials and Methods: The present randomized controlled trial was carried out in Udonthani Hospital between November 2018 and August 2019. One hundred sixteen preterm pregnant women randomly allocated into either a CL group (n=58) or a non-CL group (n=58) were included in this study. CL of less than 3 cm and persistent contractions after one to two hours rest were indications for tocolytic treatment. The proportion of preterm births within 48 hours after treatment, the proportion of tocolytic using cases, and the obstetrics and neonatal outcomes were compared between the groups. Results: Out of the 58 women in the CL group, 39.7% had a CL of less than 3 cm. Delivery within 48 hours occurred in 8.6% of the CL group compared with 15.5% in the non-CL group, which was not statistically significant. Tocolytic drug was given to 65.5% in the CL group compared with 94.8% in non-CL group (p<0.01). The participants were followed up until delivery and 55 women in the CL group and 57 women in the non-CL group completed the present study. Preterm delivery rate was 36.4% in the CL group compared with 36.8% in the non-CL group (p>0.05). There was no significant difference for the mean gestational age at delivery and neonatal complications for both groups. Conclusion: CL measurement protocol did not improve the neonatal outcome of threatened preterm labor. However, it reduced unnecessary tocolytic treatment and its associated complication. Keywords: Cervical length, Threatened preterm labor, Preterm labor, Tocolysis, Randomized trial

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A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)

BMC Pregnancy and Childbirth ◽

10.1186/s12884-019-2513-2 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 3

Author(s):

Rodolfo C. Pacagnella ◽

◽

Ben W. Mol ◽

Anderson Borovac-Pinheiro ◽

Renato Passini ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Preterm Birth ◽

Controlled Trial ◽

Transvaginal Ultrasound ◽

Cervical Length ◽

Categorical Variables ◽

Continuous Variables ◽

Short Cervix ◽

Randomized Controlled ◽

Vaginal Progesterone

Abstract Background Preterm birth is the leading cause of mortality and disability in newborn and infants. Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix. Methods This is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0/7 until 22 6/7 weeks of gestational age. Women with a cervical length below or equal to 30 mm will be randomized to the combination of progesterone (200 mg) and pessary or progesterone (200 mg) alone until 36 + 0 weeks. The primary outcome will be a composite of neonatal adverse events, to be collected at 10 weeks after birth. The analysis will be by intention to treat. The sample size is 936 women, and a prespecified subgroup analysis is planned for cervical length (= < or > 25 mm). Categorical variables will be expressed as a percentage and continuous variables as mean with standard deviation. Time to delivery will be assessed with Kaplan-Meier analysis and Cox proportional hazard analysis. Discussion In clinical practice, the combination of progesterone and pessary is common however, few studies have studied this association. The combination of treatment might act in both the biochemical and mechanical routes related to the onset of preterm birth. Trial registration Brazilian Clinical Trial Registry (ReBec) RBR-3t8prz, UTN: U1111–1164-2636, 2014/11/18.

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Pessary Compared With Vaginal Progesterone for the Prevention of Preterm Birth in Women With Twin Pregnancies and Cervical Length Less Than 38 mm: A Randomized Controlled Trial

Obstetrics and Gynecology ◽

10.1097/aog.0000000000003297 ◽

2019 ◽

Vol 133 (6) ◽

pp. 1283-1283

Author(s):

Gowri Dorairajan ◽

Bhabani Pegu

Keyword(s):

Randomized Controlled Trial ◽

Preterm Birth ◽

Controlled Trial ◽

Cervical Length ◽

Randomized Controlled ◽

Vaginal Progesterone ◽

Twin Pregnancies

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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

Acta Obstetricia Et Gynecologica Scandinavica ◽

10.1111/aogs.13545 ◽

2019 ◽

Vol 98 (6) ◽

pp. 761-768 ◽

Cited By ~ 3

Author(s):

Rupsa C. Boelig ◽

Lorraine Dugoff ◽

Amanda Roman ◽

Vincenzo Berghella ◽

Jack Ludmir

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Secondary Analysis ◽

Cervical Length ◽

Cervical Dilation ◽

Randomized Controlled

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838: Randomized controlled trial of progesterone treatment for preterm birth prevention in nulliparous women with cervical length less than 30 mm

American Journal of Obstetrics and Gynecology ◽

10.1016/j.ajog.2011.10.881 ◽

2012 ◽

Vol 206 (1) ◽

pp. S367 ◽

Cited By ~ 11

Author(s):

William Grobman

Keyword(s):

Randomized Controlled Trial ◽

Preterm Birth ◽

Controlled Trial ◽

Cervical Length ◽

Randomized Controlled ◽

Progesterone Treatment ◽

Nulliparous Women

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Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

American Journal of Speech-Language Pathology ◽

10.1044/2019_ajslp-cac48-18-0227 ◽

2020 ◽

Vol 29 (1S) ◽

pp. 412-424

Author(s):

Elissa L. Conlon ◽

Emily J. Braun ◽

Edna M. Babbitt ◽

Leora R. Cherney

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Treatment Protocol ◽

Treatment Fidelity ◽

Protocol Adherence ◽

Study Condition ◽

Randomized Controlled ◽

Aphasia Therapy ◽

Percent Accuracy ◽

Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

Journal of Speech Language and Hearing Research ◽

10.1044/2019_jslhr-l-18-0257 ◽

2019 ◽

Vol 62 (12) ◽

pp. 4464-4482 ◽

Cited By ~ 9

Author(s):

Diane L. Kendall ◽

Megan Oelke Moldestad ◽

Wesley Allen ◽

Janaki Torrence ◽

Stephen E. Nadeau

Keyword(s):

Randomized Controlled Trial ◽

Response Latency ◽

Controlled Trial ◽

Semantic Knowledge ◽

Semantic Feature ◽

Feature Analysis ◽

Group Differences ◽

Randomized Controlled ◽

Confrontation Naming ◽

Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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