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RD21/0012/0024 (Primary Care Interventions to Prevent Maternal and Child Chronic Diseases of Perinatal and Developmental Origin: RICORS network) and co- funded by the European Union (European Regional Development Fund).RD21/0012/0024 (Primary Care Interventions to Prevent Maternal and Child Chronic Diseases of Perinatal and Developmental Origin: RICORS network) and co- funded by the European Union (European Regional Development Fund).

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Cook's balloon versus dinoprostone for Labour induction of term pregnancies with fetal GROWth restriction: study protocol for a randomised controlled trial in tertiary maternity hospitals in Spain (COLIGROW study)

Publicat a:Bmj Open. 14 (9): e089628- - 2024-09-30 14(9), DOI: 10.1136/bmjopen-2024-089628

Autors: Herraiz, I; Villalain, C; Galindo, A; Barbero, P; Meler, E; Peguero, A; Figueras, F; Mazarico, E; Barberá, A; Bonacina, E; Blanco, JE; Sánchez, ML; Muñoz, IL; Pablos, DL

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Introduction Fetal growth restriction (FGR) affects about 3%-5% of term pregnancies. If prenatally detected and anterograde umbilical artery flow is preserved (stage I), it is recommended to deliver at term (>= 37+0 weeks). In the absence of contraindications, the vaginal route is preferred, and labour induction is usually required. It has been postulated that mechanical methods for cervical ripening may have an optimal profile for the induction of term FGR fetuses since they are associated with less uterine stimulation than the standard pharmacological methods, and therefore, could be better tolerated by fetuses with reduced placental reserve. This study aims to evaluate whether cervical ripening with a Cook's balloon for the induction of labour from 37+0 weeks of gestation in the stage I FGR manages to increase the rate of vaginal delivery compared with vaginal dinoprostone. Methods and analysis This will be an open-labelled, randomised, parallel-group clinical trial to be held in five Spanish maternities. Women aged >= 18 years with singleton pregnancies complicated with stage I FGR (defined as the presence of at least one of these two criteria: (1) estimated fetal weight (EFW)

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