Randomised controlled trial of manual versus instrumental rotation of the fetal head in malposition at birth

niversity College London0 个研究点目标入组 5,200 人开始时间: 2022年11月24日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•Main study:
•1. =16 years of age at time of randomisation
•2. Singleton pregnancy
•3. =36 weeks’ gestation with cephalic presentation and persistent malposition of the fetal head occiput between 2 and 10 o’clock (diagnosed clinically or with ultrasound) requiring a rotational operative vaginal birth
•4. Birth conducted or supervised by obstetricians signed off as competent in both manual and instrumental rotation (at least one of forceps/ventouse)
•Qualitative sub-study:
•1. All women eligible for ROTATE and who are approached about the trial, irrespective if they agree to participate or not
•2. All healthcare professionals caring for women in and involved in the delivery of ROTATE
•3. Those able and willing to give informed consent

•Main study:
•1. Women with contraindications for operative birth with either ventouse or forceps
•2. Women with occiput between 11 and 1 o’clock (occipito-anterior).
•3. Brow presentation
•4. Intrauterine fetal death
•Qualitative sub-study:
•1. Participants who would be unable to take part in an interview due to language barriers (interviews will be undertaken in English)

发起方

niversity College London