Ultrasound assessment of the fetal head position to prevent morbidity at instrumental delivery
| ISRCTN | ISRCTN72230496 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72230496 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/01/2011
- Registration date
- 23/02/2011
- Last edited
- 18/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Meenakshi Ramphul
Scientific
Scientific
The Coombe Women and Infants University Hospital
The Coombe
Dublin
D8
Ireland
Study information
| Study design | Multicentre individually randomised parallel two-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery |
| Study acronym | IDUS - Instrumental Delivery and UltraSound |
| Study objectives | The hypothesis is that an abdominal ultrasound scan performed in addition to routine clinical assessment reduces the incidence of incorrect diagnosis of the fetal head position which will reduce the risk of maternal and perinatal morbidity. |
| Ethics approval(s) | Granted by the Research Ethics Committee of the Coombe Women & Infants University Hospital Dublin on the 5th October 2010 |
| Health condition(s) or problem(s) studied | Fetal head position in labour |
| Intervention | Eligible women who have consented to participate in the trial will be allocated to either the usual care arm or intervention arm. Women allocated to receive usual care will be managed according to RCOG guidelines and the local hospital protocol. Women in the intervention group will be managed in the same way. In addition they will receive an ultrasound scan to assess the position of the fetal head and spine. In both groups, the mother and the neonate will be followed-up until hospital discharge. |
| Intervention type | Other |
| Primary outcome measure | Incorrect diagnosis of the fetal head position |
| Secondary outcome measures | Secondary neonatal outcomes will include trauma, low Apgar scores, low arterial blood gases and admission to the neonatal intensive care unit (NICU). Neonatal trauma will include bruising, laceration, cephalhaematoma, retinal haemorrhage, facial nerve palsy, brachial plexus injury and fractures. Paired cord blood gases will be taken routinely to measure arterial and venous pH and base excess. Arterial pH below 7.10 and base excess greater than -12.0 mmol/l will be used as the threshold to define significant fetal acidosis. Secondary maternal outcomes will include extensive perineal tearing involving the anal sphincter (third or fourth degree tears), postpartum haemorrhage, shoulder dystocia, and length of postnatal hospital stay. Primary post partum haemorrhage is defined as an estimated blood loss at delivery and in the first 24 hours of more than 500mls. Postnatal stay will be considered prolonged if more than 3 days' duration. Maternal and neonatal complications will be defined clinically according to the attending clinicians. |
| Overall study start date | 10/01/2011 |
| Completion date | 30/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 450 |
| Key inclusion criteria | The study will be limited to nulliparous women at term with singleton cephalic pregnancies, aiming to deliver vaginally who require an instrumental delivery in the second stage of labour. |
| Key exclusion criteria | Women with a contraindication to instrumental delivery, or who have a limited understanding of English or are under 18 years of age. |
| Date of first enrolment | 10/01/2011 |
| Date of final enrolment | 30/11/2013 |
Locations
Countries of recruitment
- Ireland
Study participating centre
The Coombe Women and Infants University Hospital
Dublin
D8
Ireland
D8
Ireland
Sponsor information
The Coombe Women and Infants University Hospital (Ireland)
Hospital/treatment centre
Hospital/treatment centre
The Coombe
Dublin
D8
Ireland
| Website | http://www.tcd.ie/ |
|---|---|
"ROR" |
https://ror.org/00bx71042 |
Funders
Funder type
Government
Health Research Board (Ireland)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- HRB
- Location
- Ireland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/09/2012 | Yes | No | |
| Results article | nested observational study results | 01/03/2015 | 18/02/2021 | Yes | No |
Editorial Notes
18/02/2021: Publication reference added.
