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

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.

Drug use during pregnancy and its consequences: A nested case control study on severe maternal morbidity / Uso de drogas na gestação e suas consequências: um estudo de caso-controle aninhado sobre morbidade materna grave

Abstract Objective To assess the relationship between the use of psychoactive substances during pregnancy and the occurrence of severe maternal morbidity (SMM), perinatal outcomes and repercussions on the neuropsychomotor development of exposed children. Methods A case-control study nested within a cohort of severe maternal morbidity (COMMAG) was performed. Women with SMM were considered cases. Controls were thosewith low-risk pregnancy,without SMMand admitted during the same time period as the cases. Cohort data were collected retrospectively in hospital records for childbirth. A face-to-face interview was also performed with 638 women (323 without SMM and 315 with SMM) and their children of the index pregnancy between 6 months and 5 years after childbirth. During the interview, substance abuse during pregnancy was assessed by a modified question from the Alcohol, Smoking and Substance Involvement Screening Test 2.0 (ASSIST) and the neuropsychomotor development in the children was assessed by the Denver Developmental Screening Test, 2nd edition. Results The prevalence of licit or illicit drug use during pregnancy was ~ 17%. Among drug users, 63.9% used alcohol, 58.3% used tobacco, 9.2% used cocaine/crack and 4.6% used marijuana. There was no association between drug use during pregnancy and SMM, although tobacco use during pregnancy was associated with bleeding, presence of near-miss clinical criteria (NMCC) and alteration in infant development; alcohol use was associated with neonatal asphyxia; and cocaine/crack use was associated with the occurrence of some clinical complications during pregnancy. Conclusion The use of psychoactive substances during pregnancy is frequent and associated with worse maternal, perinatal and child development outcomes.

Resumo Objetivo Avaliar a relação entre o uso de substâncias psicoativas na gestação e a ocorrência de morbidade materna grave (MMG), resultados perinatais e repercussões no desenvolvimento neuropsicomotor das crianças expostas. Métodos Estudo de caso-controle a partir de uma coorte de morbidade materna grave (COMMAG). Mulheres com MMG foram consideradas casos. Controles foram mulheres com gestação de baixo risco, admitidas no mesmo período que os casos. Os dados da coorte foram coletados retrospectivamente em prontuários de internação para o parto e entrevistas presenciais conduzidas com 638 mulheres e seus filhos da gestação-índice, entre 6 meses e 5 anos após o parto. Na entrevista, o uso de substâncias na gestação foi avaliado com uma pergunta modificada introduzida no questionário para triagem do uso de álcool, tabaco e outras substâncias 2.0 (ASSIST, na sigla em inglês) e o desenvolvimento neuropsicomotor das crianças foi avaliado pelo teste de triagem do desenvolvimento Denver II. Resultados A prevalência do uso de drogas lícitas ou ilícitas na gestação foi de cerca de 17%. Das usuárias, 63,9% usaram álcool, 58,3% usaram tabaco, 9,2% usaram cocaína/crack e 4,6% usaram maconha. Não houve associação entre o uso de drogas na gestação eMMG. Contudo, o uso de tabaco foi associado a hemorragia, presença de critérios clínicos de near miss e alteração no desenvolvimento infantil. O uso de álcool foi associado à asfixia neonatal e o uso de cocaína/crack à ocorrência de alguma complicação clínica na gestação. Conclusão O abuso de substâncias lícitas ou ilícitas na gestação é frequente e associado a piores desfechos maternos, perinatais e do desenvolvimento infantil.

Drug Use during Pregnancy and its Consequences: A Nested Case Control Study on Severe Maternal Morbidity.

OBJECTIVE: To assess the relationship between the use of psychoactive substances during pregnancy and the occurrence of severe maternal morbidity (SMM), perinatal outcomes and repercussions on the neuropsychomotor development of exposed children. METHODS: A case-control study nested within a cohort of severe maternal morbidity (COMMAG) was performed. Women with SMM were considered cases. Controls were those with low-risk pregnancy, without SMM and admitted during the same time period as the cases. Cohort data were collected retrospectively in hospital records for childbirth. A face-to-face interview was also performed with 638 women (323 without SMM and 315 with SMM) and their children of the index pregnancy between 6 months and 5 years after childbirth. During the interview, substance abuse during pregnancy was assessed by a modified question from the Alcohol, Smoking and Substance Involvement Screening Test 2.0 (ASSIST) and the neuropsychomotor development in the children was assessed by the Denver Developmental Screening Test, 2nd edition. RESULTS: The prevalence of licit or illicit drug use during pregnancy was ∼ 17%. Among drug users, 63.9% used alcohol, 58.3% used tobacco, 9.2% used cocaine/crack and 4.6% used marijuana. There was no association between drug use during pregnancy and SMM, although tobacco use during pregnancy was associated with bleeding, presence of near-miss clinical criteria (NMCC) and alteration in infant development; alcohol use was associated with neonatal asphyxia; and cocaine/crack use was associated with the occurrence of some clinical complications during pregnancy. CONCLUSION: The use of psychoactive substances during pregnancy is frequent and associated with worse maternal, perinatal and child development outcomes.

OBJETIVO: Avaliar a relação entre o uso de substâncias psicoativas na gestação e a ocorrência de morbidade materna grave (MMG), resultados perinatais e repercussões no desenvolvimento neuropsicomotor das crianças expostas. MéTODOS: Estudo de caso-controle a partir de uma coorte de morbidade materna grave (COMMAG). Mulheres com MMG foram consideradas casos. Controles foram mulheres com gestação de baixo risco, admitidas no mesmo período que os casos. Os dados da coorte foram coletados retrospectivamente em prontuários de internação para o parto e entrevistas presenciais conduzidas com 638 mulheres e seus filhos da gestação-índice, entre 6 meses e 5 anos após o parto. Na entrevista, o uso de substâncias na gestação foi avaliado com uma pergunta modificada introduzida no questionário para triagem do uso de álcool, tabaco e outras substâncias 2.0 (ASSIST, na sigla em inglês) e o desenvolvimento neuropsicomotor das crianças foi avaliado pelo teste de triagem do desenvolvimento Denver II. RESULTADOS: A prevalência do uso de drogas lícitas ou ilícitas na gestação foi de cerca de 17%. Das usuárias, 63,9% usaram álcool, 58,3% usaram tabaco, 9,2% usaram cocaína/crack e 4,6% usaram maconha. Não houve associação entre o uso de drogas na gestação e MMG. Contudo, o uso de tabaco foi associado a hemorragia, presença de critérios clínicos de near miss e alteração no desenvolvimento infantil. O uso de álcool foi associado à asfixia neonatal e o uso de cocaína/crack à ocorrência de alguma complicação clínica na gestação. CONCLUSãO: O abuso de substâncias lícitas ou ilícitas na gestação é frequente e associado a piores desfechos maternos, perinatais e do desenvolvimento infantil.