Vaginal progesterone preterm birth

OBJECTIVES: Primary outcomes were to determine; 1) the desire for more patient information from healthcare professionals on preterm birth (PTB) prevention 2) the desire for PTB screening surveillance or participation in research or 3) the acceptability of transvaginal ultrasound (TVUS) or vaginal examinations to predict spontaneous PTB. METHODS: A 19-question, piloted, self-administered survey was completed by unselected pregnant women in a tertiary maternity hospital in Dublin, Ireland...

After the FDA pulled 17-hydroxyprogesterone caproate from the market for its use in prevention of recurrent spontaneous preterm birth, national societies have had mixed recommendations regarding the management of patients with a singleton pregnancy and prior spontaneous preterm birth. Here we highlight the randomized trial data and translational evidence supporting the use of vaginal progesterone for prevention of recurrent spontaneous preterm birth in singleton pregnancies. Prophylactic vaginal progesterone starting at 16 week 0 days every night should be offered to singletons with prior singleton spontaneous preterm birth regardless of cervical length, and continued along with placement of cerclage if a transvaginal ultrasound cervical length ≤25mm is detected at < 24 weeks...

Objective: To evaluate the effectiveness of vaginal progesterone in preventing preterm birth in women with a singleton gestation and short cervical length and to determine which of the two formulations, micronized progesterone vaginal capsule versus vaginal gel containing micronized progesterone, is more effective for preventing preterm birth. Data sources: A systematic search was performed in the following databases: EMBASE, PubMed (MEDLINE), The Cochrane Library, and the Clinical Trials Registry (clinicaltrials...

UNLABELLED: The occurrence of vaginal bleeding in early neonatal life has been observed for centuries and was considered a consequence of the sudden drop in circulating hormones following birth. As such, neonatal uterine bleeding was dismissed as having no clinical significance. Interest in the phenomenon was renewed when a new theory suggested a link between neonatal uterine bleeding (NUB) and accelerated endometrial maturation. This theory was based on the observation of a higher incidence of NUB in babies born post-term or after pregnancies complicated by intrauterine growth restriction, preeclampsia, or blood group incompatibility...

IMPORTANCE: A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting. OBJECTIVE: To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix. DESIGN, SETTING, AND PARTICIPANTS: We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US...

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BACKGROUND: There are few medicines in clinical use for managing preterm labor or preventing spontaneous preterm birth from occurring. We previously developed two target product profiles (TPPs) for medicines to prevent spontaneous preterm birth and manage preterm labor. The objectives of this study were to 1) analyse the research and development pipeline of medicines for preterm birth and 2) compare these medicines to target product profiles for spontaneous preterm birth to identify the most promising candidates...

The U.S. Food and Drug Administration has recently withdrawn approval for 17-α hydroxyprogesterone caproate for prevention of recurrent preterm birth, and recent studies have called into question benefits of the pessary in the setting of a short cervix. Obstetric health care professionals are once again left with limited remaining options for preterm birth prevention. This narrative review summarizes the best current evidence on the use of vaginal progesterone, low-dose aspirin, and cerclage for the prevention of preterm birth; attempts to distill possible lessons learned from studies of progesterone and pessary, as well as their implementation into practice; and highlights areas where inroads into preterm birth prevention may be possible outside of the progesterone-aspirin-cerclage paradigm...

INTRODUCTION: Cervical insufficiency accounts for 15% of recurrent pregnancy losses between 16 and 28 weeks of gestation. The aim of the study is to verify the effectiveness of emergency double-level cerclage with vaginal progesterone in cervical insufficiency treatment in terms of the prevention of preterm delivery before 34 weeks of gestation. METHODS AND ANALYSIS: This trial is a multicentre, non-blinded, randomised study with 1:1 allocation ratio. The study is conducted at tertiary perinatal care departments in Poland...

OBJECTIVE:  To describe a reference curve for cervical length (CL) in mid-trimester twin gestations using transvaginal ultrasound (TVU) and to investigate whether short CL increases spontaneous preterm birth (sPTB) in asymptomatic twin pregnancies. METHODS:  This was a prospective cohort study performed at 17 outpatient antenatal facilities of Brazil with women at 18 0/7 to 22 6/7 weeks of gestation who participated in a randomized clinical trial screening phase (P5 trial) between July 2015 and March 2019...

OBJECTIVE: Vaginal progesterone and cervical cerclage are both effective interventions for reducing preterm birth. It is currently unclear whether combined therapy offers superior effectiveness than single therapy. This study aimed to determine the efficacy of combining cervical cerclage and vaginal progesterone in the prevention of preterm birth. DATA SOURCES: We searched Medline (Ovid), EMBASE (Ovid), PsycINFO (Ovid), CINAHL (EBSCOhost), Cochrane Library (Wiley), and Scopus (from their inception to 2020)...

OBJECTIVE: To evaluate the efficacy of vaginal progesterone for the prevention of preterm birth and adverse perinatal outcomes in twin gestations. DATA SOURCES: MEDLINE, Embase, LILACS, and CINAHL (from their inception to January 31, 2023), Cochrane databases, Google Scholar, bibliographies, and conference proceedings. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials that compared vaginal progesterone to placebo or no treatment in asymptomatic women with a twin gestation...

OBJECTIVES: To determine if 17α-hydroxyprogesterone caproate (17OHPC) or vaginal progesterone use for patients at risk for preterm birth has changed since the publication of the 17-OHPC to Prevent Recurrent Preterm Birth in Singleton Gestations (PROLONG) trial, and to assess which organizations' (Food and Drug Administration's [FDA], American College of Obstetrics and Gynecology's [ACOG] or Society of Maternal Fetal Medicine's [SMFM]) statements most influenced change. METHODS: Through a vignette-based physician survey, we sought to measure (by Likert scale) how counseling tendencies regarding 17OHPC and vaginal progesterone have changed since the PROLONG trial publication...

OBJECTIVE: To assess the incidence of threatened preterm labor and preterm labor admissions and treatment of women with singleton gestations and no prior preterm birth before and after implementation of the universal mid-trimester transvaginal ultrasound cervical length screening. MATERIALS AND METHODS: A retrospective cohort study included of singleton gestations without a history of preterm birth presenting with threatened preterm labor between 24 0/7 and 36 6/7 gestational week in two study periods: before and after the implementation of the universal cervical length screening...

A package of care for all pregnant women within eight scheduled antenatal care contacts is recommended by WHO. Some interventions for reducing and managing the outcomes for small vulnerable newborns (SVNs) exist within the WHO package and need to be more fully implemented, but additional effective measures are needed. We summarise evidence-based antenatal and intrapartum interventions (up to and including clamping the umbilical cord) to prevent vulnerable births or improve outcomes, informed by systematic reviews...

OBJECTIVE: The frequency of intrahepatic cholestasis of pregnancy (ICP) peaks during the third trimester of pregnancy when plasma progesterone levels are the highest. Furthermore, twin pregnancies are characterized by higher progesterone levels than singletons and have a higher frequency of cholestasis. Therefore, we hypothesized that exogenous progestogens administered for reducing the risk of spontaneous preterm birth may increase the risk of cholestasis. Utilizing the large IBM MarketScan Commercial Claims and Encounters Database, we investigated the frequency of cholestasis in patients treated with vaginal progesterone or intramuscular 17α-hydroxyprogesterone caproate for the prevention of preterm birth...

On April 5, 2023, the US Food and Drug Administration withdrew the approval of 17-alpha hydroxyprogesterone caproate, effective immediately, because of the lack of evidence that it reduces the risk of recurrent spontaneous preterm birth. This decision withdraws approval for all formulations of 17-alpha hydroxyprogesterone caproate (both intramuscular and subcutaneous) and applies to both brand name (Makena) and generic versions of the medication. We agree with the Food and Drug Administration determination and discourage continued prescribing of 17-alpha hydroxyprogesterone caproate, including through compounding pharmacies...

BACKGROUND: Short cervical length measured during the second trimester of pregnancy is an important risk factor for spontaneous preterm birth (sPTB). The aim of this study is to identify the association between mid-pregnancy cervical length (CL) and gestational age at birth in asymptomatic singleton pregnant women. METHODS: This is a prospective cohort study involving singleton pregnant women who participated in the screening phase of a Brazilian multicenter randomized controlled trial (P5 trial) between July 2015 and March 2019...

OBJECTIVE: To assess the impact of progesterone treatment on maternal and neonatal outcomes in women with a history of preterm birth and short cervical length diagnosed after 24 weeks of gestation. METHODS: A retrospective cohort study included women with a history of preterm birth and a transvaginal sonographic cervical length measurement of ≤ 25 mm, diagnosed between 24+0 and 33+6 weeks of gestation. Exclusion criteria included prior progesterone treatment, cervical cerclage, or pessary...

Natural language processing-the branch of artificial intelligence concerned with the interaction between computers and human language-has advanced markedly in recent years with the introduction of sophisticated deep-learning models. Improved performance in natural language processing tasks, such as text and speech processing, have fueled impressive demonstrations of these models' capabilities. Perhaps no demonstration has been more impactful to date than the introduction of the publicly available online chatbot ChatGPT in November 2022 by OpenAI, which is based on a natural language processing model known as a Generative Pretrained Transformer...