Introduction: Currently, the majority of women worldwide with threatened preterm birth are treated with tocolytics. Although tocolytics can effectively delay birth for 48 hours, no tocolytic drug has convincingly been shown to improve neonatal outcomes and effects on long-term child development are unknown. The aim of this follow-up study of a placebo controlled randomised trial is to investigate the long-term effects of atosiban administration in case of threatened preterm birth on child's neurodevelopment and behaviour development, overall health and mortality.
Methods And Analysis: This protocol concerns a follow-up study of the multicentre randomised double-blind placebo controlled APOSTEL 8 trial (NL61439.018.17, EudraCT-number 2017-001007-72). In this trial, women with threatened preterm birth (between 30 and 34 weeks of gestation) defined as uterine contractions with (1) a cervical length of <15 mm or (2) a cervical length of 15-30 mm and a positive fibronectin test or (3) in centres where cervical length measurement is not part of the local protocol: a positive fibronectin test or Actim-Partus test or (4) ruptured membranes, are randomised to atosiban or placebo for 48 hours. The primary outcome is a composite of perinatal mortality and severe neonatal morbidity. Children born to mothers who participated in the APOSTEL 8 study (n=760) will be eligible for follow-up at 4 years of corrected age and assessed using four parent-reported questionnaires. Primary outcomes are neurodevelopment and behaviour problems. Secondary outcomes are on child growth and general health. All outcomes will be compared between the atosiban and placebo group with OR and corresponding 95% CI. Analyses will be performed using the intention-to-treat approach.
Ethics And Dissemination: The Medical Research Ethics Committee from Amsterdam UMC confirmed that de Medical Research Involving Human Subjects Act (Dutch WMO-law) did not apply to our study (W21_386 # 21.431). Results will be published in a peer-reviewed journal and shared with stakeholders and participants. This protocol is published before analysis of the results.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11261668 | PMC |
http://dx.doi.org/10.1136/bmjopen-2023-083600 | DOI Listing |
Int J Gynaecol Obstet
December 2024
Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Threatened miscarriage is defined as early vaginal bleeding before 12 weeks of gestational age and can occur in any pregnancy regardless of maternal age, race, comorbidities, lifestyle, or socioeconomic status, and about one-quarter of threatened miscarriages proceed to complete miscarriage. To assess the relative effectiveness and safety of different progestogens in women with first threatened miscarriage, using a network meta-analysis. A systematic search was conducted in PubMed, EMBASE, and Cochrane Library databases from inception to April 2023.
View Article and Find Full Text PDFJ Dtsch Dermatol Ges
December 2024
Department of Dermatology, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan.
Background And Objectives: Studies have identified increased risks of pregnancy complications in expectant mothers with atopic dermatitis (AD). However, the associations between maternal AD and adverse pregnancy or offspring outcomes in Asians remain unexplored. Our aim was to investigate the relationship between maternal AD and adverse pregnancy and offspring outcomes in Taiwan.
View Article and Find Full Text PDFInt J Gynaecol Obstet
December 2024
Service de Gynécologie Obstétrique, CHU Charles-Nicolle, Rouen, France.
Fetal death is defined as the spontaneous cessation of cardiac activity after 14 weeks gestational age (GA). Regarding prevention of fetal death in the general population, it is not recommended to counsel or prescribe rest, aspirin, vitamin A, vitamin D, or micronutrient supplementation; systematically look for nuchal cord during prenatal screening ultrasound; or perform systematic antepartum monitoring by cardiotocography for the sole purpose of reducing the risk of fetal death. It is recommended to offer vaccination against influenza in epidemic periods and against SARS-CoV-2.
View Article and Find Full Text PDFBMC Pregnancy Childbirth
December 2024
Department of Epidemiology and Health Statistics, School of Public Health, Sun Yat-Sen University, Guangzhou, 510080, China.
J Obstet Gynaecol Can
December 2024
La Paz University Hospital Obstetrics and Gynaecology Department, Madrid.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!