Fetal head in malposition at birth Pregnancy and Childbirth
Conditions
Interventions
Interventions (health technologies) being assessed:
INTERVENTION – MANUAL ROTATION: Rotation of the fetal head by manual rotation - followed by direct forceps or direct ventouse or spontaneous effort
and the evidence synthesis by HTA "There was no significant difference in the risk ratio between [rotational] forceps & rotational ventouse in adverse maternal outcomes".
In a national survey (with f
Sponsors
University College London
Eligibility
Sex/Gender
Female
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anal sphincter injury and Caesarean section (co-primary outcomes) measured from data collection on case report forms, including a checklist for the standardisation of perineal assessment, and documentation of the need for caesarean section. Completed immediately after birth. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maternal and neonatal morbidity/mortality collected on a case report form within 48 hours of birth 2. Urinary incontinence measured using the International Consultation on Incontinence Questionnaire within 48 hours of birth and at 3 months after birth 3. Fecal incontinence measured using the Fecal Incontinence Quality of Life Questionnaire within 48 hours of birth and at 3 months after birth 4. Impact on infant feeding measured using the Breastfeeding Questionnaire within 48 hours and at 3 months after birth 5. Birth experience measured using the Childbirth Experience Questionnaire within 48 hours and at 3 months after birth 6. Birth trauma measured using the CITY Birth Trauma scale at 3 months after birth | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Outcome results
None listed