Condition category
Pregnancy and Childbirth
Date applied
06/10/2016
Date assigned
06/12/2016
Last edited
14/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

This research is in 2 phases.

Phase1: Lacking capacity in an obstetric emergency, a retrospective study of maternal capacity.
Phase2: Lacking capacity in an obstetric emergency, a randomized controlled trial investigating whether prior information about obstetric emergencies improves later decision making capacity.

The Mental Capacity Act (MCA) 2005 was introduced to protect patients’ autonomy and to provide for those lacking capacity. It has significant implications for consent in obstetric emergencies.

Due to the nature of obstetric emergencies, informed consent is challenging. Fear of fetal well-being, severe labour pains, strong opiates and emotional (dis)stress all affect capacity. Formal assessment of capacity takes considerable time, which may compromise fetal outcome through undue delay.

We recently conducted an audit and found that the majority of women interviewed within 24 hrs of an obstetric emergency, had no recollection of the consent process or risks of complications. Many admitted to not reading the consent form at all.

In phase1, we assess a mother’s ability to give informed consent in an emergency by conducting interviews within 24 hrs of birth, using a capacity assessment tool designed by us that incorporates basic principles of the MCA, based upon maternal recall of events.

In phase2: we are testing whether written information, supported by verbal counselling, before an emergency has occurred improves women’s decision making ability when an emergency occurs subsequently.

Women admitted for induction of labour or early labour will be randomized to receive additional information (intervention) or not (control). Those women who end up in theatre for an instrumental or caesarean delivery will be interviewed within 24 hrs to assess their capacity at the time of emergency.
Usual practice is to take consent when an emergency arises.

This study will be conducted at Glan Clwyd Hospital and will last approximately 12 months. BCUHB will be the sponsor.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neelam Singh

ORCID ID

Contact details

Maternity Unit
Glan Clwyd Hospital NHS Trust
Rhuddlan Road
Rhyl
LL18 5UJ
United Kingdom
+44 1745 583910 ext. 4657
neelam.singh@wales.nhs.uk

Type

Scientific

Additional contact

Mr Philip Banfield

ORCID ID

Contact details

Maternity Unit
Glan Clwyd Hospital NHS Trust
Rhyl
LL18 5UJ
United Kingdom
+44 1745 583910
philip.banfield@wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS 183899

Study information

Scientific title

Lacking Capacity in Obstetric Emergencies

Acronym

Study hypothesis

A timely intervention in the form of written information supported with verbal counselling improves women's decision making ability.

Ethics approval

Wales REC 4, 27/11/2015, ref: 15/WA/0273

Study design

Phase 1: Observational cross-sectional retrospective case assessment
Phase 2: Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Women's health

Intervention

All women who have been to theatre for an obstetric emergency delivery (code 1 or code 2) are assessed and interviewed using the R-CAT tool to assess their capacity in retrospect. This is done ideally as soon as possible and within 24 hours after the emergency event had happened.
The R-CAT tool involves reviewing patient notes for details about the delivery (such as reason for going to theatre, urgency, and use of pain relief) and an interview with the patient. The interview takes approximately 40 minutes to complete and involves asking questions about the events around the delivery to find out what patient can recall and what she understood at that time.

Phase 2:
Women will be randomized to one of two groups using the online system of randomization facilitated by the R&D department of BCUHB.

Control group: Women will be treated in the routine manner as per national guidelines with no additional information or intervention and if she ends up in theatre for emergency delivery, then will be approached by the research team to make and assessment of her capacity in retrospect, using our specially designed R-CAT tool which combines the principles of Mental Capacity Act 2005 with McArthur’s capacity assessment tool. This assessment will be done within 24 hours of delivery.

Intervention group: Women will receive written information with verbal counselling regarding the possible obstetric emergency procedures. If she continues to deliver normally and does not need to go to theatre, nothing needs to be done, however if she does need to go to theatre as an Obstetric emergency and have delivery in theatre, This patient post delivery will be assessed by using the R-CAT tool to make a retrospective assessment of her capacity at the point she was taken to theatre. This assessment is done as soon as possible after the delivery but within 24 hours of patient having been to theatre.

All participants are interviewed within 24 hours of delivery, otherwise there is no other follow up.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Phase 1 and 2:
Capacity is measured using the R CAT tool within 24 hours of delivery.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

31/12/2015

Overall trial end date

01/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Phase 1:
1. Aged 16 years and over
2. Singleton live pregnancy
3. ≥ 36 weeks pregnancy
4. Those who have been to theatre for an obstetric emergency delivery

Phase 2
1. All women admitted for induction of labour or in very early labour judged not to be under the influence of opiate analgesia
2. Aged 16 years and over
3. Singleton live pregnancy
4. ≥ 36 weeks pregnancy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Phase 1: The sample size will be based on a pilot study that preceded this application such that 90 participants will be recruited to assess their capacity in retrospect after the event. Phase2: 250 control Group and 250 intervention Group.

Participant exclusion criteria

Phase 1 and 2:
1. Under 16 years of age
2. Learning disability
3. Organic mental disorders
4. In significant pain or under the influence of opiate analgesia

Recruitment start date

01/01/2016

Recruitment end date

01/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glan Clwyd Hospital
Glan Clwyd Hospital NHS Trust BCUHB Rhuddlan Road
Rhyl
LL18 5UJ
United Kingdom

Sponsor information

Organisation

Betsi Cadwaladr University Health Board

Sponsor details

Research & Develpoment
Ysbyty Gwynedd Hospital
Bangor
LL57 2PW
United Kingdom
+44 1248 384877
rossela.roberts@wales.nhs.uk

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Betsi Cadwaladr University Health Board

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in the BJOG (British Journal of Obstetrics & Gynaecology).

Intention to publish date

01/09/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes