Trial registration data for the EOLE study
| Data category | Information |
|---|---|
| Primary registry and trial identifying number | ClinicalTrials.gov NCT02474745 |
| Date of registration in primary registry | 5 June 2015 |
| Secondary identifying numbers | AU 1168, 2014-A01920-47, 150099B-22 |
| Source(s) of monetary or material support | French Ministry of Health (grant number PHRC 2005 05.09) |
| Primary sponsor | Délégation de la Recherche Clinique, Centre Hospitalier Universitaire de Clermont-Ferrand |
| Secondary sponsor(s) | NA |
| Contact for public queries | cbarasinski@chu-clermontferrand.fr |
| Contact for scientific queries | cbarasinski@chu-clermontferrand.fr fvendittelli@chu-clermontferrand.fr |
| Public title | Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial—the EOLE Study |
| Scientific title | Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial—the EOLE Study |
| Countries of recruitment | France |
| Health condition(s) or problem(s) studied | Delivery, 2nd stage of labour |
| Intervention(s) | Intervention group: Directed open-glottis pushing |
| Control group: Directed closed-glottis pushing | |
| Key inclusion and exclusion criteria | Ages eligible for study:≥18 years Sexes eligible for study: Female Accepts healthy volunteers: Yes |
| Inclusion criteria: Women who are nulliparous or multiparous (≥1 previous child), who attended a complete training session about the types of pushing assessed in this trial during prenatal childbirth preparation and parenthood classes (regardless of the type of prenatal preparation), for whom a vaginal delivery was planned at the end of pregnancy, admitted to the maternity ward between 37 and 42 weeks of gestation (≥37 and ≤42 weeks) in spontaneous or induced labour, with cervical dilation ≥7 cm, with a singleton pregnancy in cephalic presentation, who provided informed consent in writing and who speaks and writes French. | |
| Exclusion criteria: Minors or adults incapable of providing consent for the study or with a disorder contraindicating prolonged pushing or with a uterine scar (previous caesarean or other surgery) or with a contraindication to vaginal delivery or a maternal disease that could justify in termination of the pregnancy (hemolysis, elevated liver enzymes and low platelets count syndrome, pre-eclampsia (hypertension with albuminuria >0.3 g per 24 hours), eclampsia, abruptio placentae, etc) or with a major genital haemorrhage or a major fetal malformation and/or hydramnios or oligohydramnios, and/or fetal growth restriction (<5th centile) diagnosed in utero, or with a fetal heart rate anomaly before randomisation or in utero fetal death or multiple pregnancy. | |
| Study type | Interventional |
| Randomised, controlled, non-blinded multicentre superiority trial with 2 parallel groups | |
| Date of first enrolment | July 2015 |
| Target sample size | 250 |
| Recruitment status | Currently recruiting |
| Primary outcome(s) | Composite criterion: spontaneous delivery without perineal lesion (episiotomy, spontaneous second-degree, third-degree or fourth-degree lacerations) |
| Key secondary outcomes | Occurrence of perineal lesions such as episiotomy or a severe perineal laceration Immediate postpartum haemorrhage Effect on pelvic floor and urinary function (POP-Q and ICIQ-SF) Women’s satisfaction, assessed by a validated Swiss questionnaire |
ICIQ-SF, International Consultation on Incontinence modular Questionnaire-Short Form; NA, not applicable; POP-Q, Pelvic Organ Prolapse Quantification System.