Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001577202
Ethics application status
Approved
Date submitted
17/09/2018
Date registered
21/09/2018
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The post-operative review as an opportunity to intervene for postnatal depression in mothers undergoing Caesarean section
Scientific title
The post-operative review as an opportunity to intervene for postnatal depression in mothers undergoing Caesarean section: A randomised controlled trial performed at North Shore Hospital, Auckland, New Zealand.
Secondary ID [1] 296008 0
Nil known
Universal Trial Number (UTN)
U1111-1219-9639
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
postnatal depression 309544 0
Condition category
Condition code
Reproductive Health and Childbirth 308362 308362 0 0
Childbirth and postnatal care
Mental Health 308517 308517 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• This open-label, two-arm, parallel, active-controlled, randomised superiority study seeks to determine whether a brief, standardised intervention, delivered by a Senior House Officer (SHO) at the post-Caesarean section review, can reduce the rates of undiagnosed and untreated PND in the early postnatal period for mothers undergoing Caesarean section

• Mothers randomised to the intervention group will be educated about PND, and given the resources to conduct their own PND screening using the EPDS which is then linked to local support services with text message reminders over the first 6 weeks postpartum
___________

The education will be part of the one off SHO review. The review lasts anywhere from 10-30 minutes. The time spent discussing PND will be around 2 minutes. In addition to routine post-op advice the SHO will: Explain that PND is a common condition affecting up to 20% of mothers. Explain that early recognition is key and that there is good help available. Provide the information package to mother. Explain that the package contains links to information and advice for where to get help if needed. Encourage her to read the package and complete the relevant sections at the appropriate time. Inform her that if she has any questions about the package, she can ask to speak to the on-call SHO at any time while in hospital.
___________

The specific resource given is a 4 page document. Page One contains an introduction to the prevalence, and symptoms of PND, with an explanation of how to use the EPDS scores in the package to access local supports. There is also a recommendation to download the “Mind the Bump” phone app a free mindfulness mediation program for new parents

___________

Page 2-3: Contain two EPDS, one to be completed while in hosptial after the SHO review, the other at week 6. Each EPDS score channels into three streams of advice, as below.

D1 Score 0-9: This is a low risk score for PND. We encourage you to be mindful of your mental health and wellbeing and remember to repeat this questionnaire in six weeks’ time.


D1 Score 10-12: This predicts mild to moderate risk of significant anxiety and depression. Please discuss this result with your midwife or ask to speak to the on-call Senior House Officer. It may be useful to look at the online resources listed on Page 4.

D1 Score 13 or more OR EPDS Q10 score 2-3: This predicts a high chance of significant anxiety and depression and requires follow up. Our strong advice is talk to a doctor (in hospital or your GP), as well as your midwife. The online resources listed on Page 4 may also be beneficial.

W6 Score 0-9: This is a low risk score for PND. We encourage you to be mindful of your mental health and wellbeing over the coming months and wish you all the best.

W6 Score 10-12: This predicts mild to moderate risk of significant anxiety and depression. It would be a good idea to mention this to your GP when you go for baby’s check-up; they can organise appropriate follow up which may consist of repeat this questionnaire in a few weeks’ time. It may be useful to look into the online resources listed on Page 4 if you have not done so already.

W6 Score 13 or more OR EPDS Q10 score 2-3: This predicts a high chance of significant anxiety and depression and requires follow up. Please take this questionnaire to your doctor when you go for baby’s check-up. It may be useful to look into the online resources listed on Page 4 if you have not done so already.

The Local services linked from these scores include WDHB mental health and crisis teams, PND/Depression/Mindfulness websites, phone numbers of e.g. Lifeline, contacts for WDHB cultural services (Maori, Asian, Pacific), contacts for WDHB social workers, drug and alcohol support groups, and family violence support.
___________

The frequency and content of the text messages are as follows:

Day Two Postnatal: Intervention Group

Hello. This is a friendly reminder from the WDHB Maternity Ward to “check in” with your mental health using our information pack. If you have not done so already, please complete the questionnaire on Page 2. You can find an online copy of the questionnaire by following this link: http://perinatology.com/calculators/Edinburgh%20Depression%20Scale.htm. To receive a copy of the information package electronically, email [email protected]. We wish you all the best until we touch base again in a few weeks. Please do not reply to this text message; if you have any concerns please talk to your GP or midwife. If you are still in hospital, then you can also ask to see the on-call Senior House Officer.


Week Three Postnatal: Intervention Group

Hello from the WDHB Maternity team. It is now about 3 weeks since you gave birth. We hope that the process of adjusting to life at home with your new baby is going well. If you get a moment, we encourage you to look at the mobile app, “Mind the Bump”, which is available on the Google Play Store (Android), and the App Store (Apple). This is a free mindfulness mediation program for parents. If you have downloaded this already, then well done, and we encourage you to continue practicing the techniques and skills it covers. Take care, and we will be in touch again in another few weeks. Please do not reply to this text message; if you have any concerns please talk to your GP or midwife.


Week Six Postnatal: Intervention Group

Hello again from the WDHB Maternity Ward. It is now about 6 weeks since you gave birth. This is a reminder to please complete the questionnaire on Page 3 of the information pack. You can find an online copy of the questionnaire by following this link: http://perinatology.com/calculators/Edinburgh%20Depression%20Scale.htm. To receive an electronic copy of the information package you were given in hospital, email [email protected]. You will soon be seeing your GP for baby’s 6 week examination. This is a great time to touch base with a doctor to discuss any concerns you may have about your mental health. If this marks the end of your contact with WDHB for this pregnancy, then once again, congratulations, and good luck for the months and years ahead. Please do not reply to this text message; if you have any concerns please talk to your GP or midwife.

Week Eight Postnatal Follow Up: Control Group and Intervention Group

Hello from the WDHB Maternity Ward. It is now 8 weeks since you gave birth. While in hospital you met with one of our doctors or midwifes, and kindly agreed to participate in a research project. This study looked at aspects of discharge planning and follow up for mothers whose babies were born by Caesarean section. The key focus of the study was the issue of Postnatal Depression (PND). One of the study authors will call you this evening around 8 pm and ask you some questions that will not take more than 5 minutes. We ask that you please follow this link prior to 8pm, tick the box for each question that is most accurate for you, and remember your total score: http://perinatology.com/calculators/Edinburgh%20Depression%20Scale.htm. If 8pm is not good for you, please reply to this text with a more convenient time. We thank you again for agreeing to participate in this research project aimed at improving health care for mothers in the Waitemata DHB

__________

Adherence and value of the intervention pack will be assessed at the week 8 follow up phone call for those in the intervention group. The questions are listed below. The strategy impolyed to maintain fidelity is the text message reminders discussed above.
1. Did you read through the information package provided when you were at NSH? Please rate its value from 1 (not at all) to 5 (very).
2. Did you receive text messages from us after giving birth? Please rate their value in helping you focus on your mental health and wellbeing from 1 (not at all) to 5 (very).
3. Did you download and use the “Mind the Bump App”? Please rate its value from 1 (not at all) to 5 (very).
4. Did you complete one or both EPDS questionnaires as recommended in the package? If so, can you provide the results
5. Do you have any feedback to improve the information package?
Intervention code [1] 312340 0
Early detection / Screening
Comparator / control treatment
Routine care, defined as the SHO review as outlined below, omitting the statement regarding PND as detailed above:
Operation Details:
- Date and time of operation
- Category and indication
- Complications including estimated blood loss and specific post-operative instructions
- Suitability for VBAC

Patient Background:
- Relevant medical history
- Relevant complications in the pregnancy
- Pre-operative haemoglobin and blood group

Observations:
- Full set of current vitals and any concerning readings or trends

Subjective History:
- Maternal concerns and questions. Debrief and explain operation as indicated
- Check mobility, whether eating and drinking, whether passed urine and flatus, whether pain controlled and if managed to get sleep, whether initiated breastfeeding, whether any concerning vaginal bleeding or vaginal discharge

Objective History:
- General examination as indicated: Checking at least level of distress, level of consciousness, peripheral perfusion, presence of TED stockings, and the presence of any medical devices such as drains, IDCs, and IVLs.
- Abdomen: Inspect, palpate, percuss, auscultate, noting especially location and tone of uterus, whether any abdominal distension or pain, whether bowel sounds are active, and whether there is any excessive ooze or bleeding from wound
- Pad check: Check lochia and vaginal bleeding

Assessment:
- Specific concerns
- Whether or not to remain under obstetric care or if suitable for discharge to midwifery care

Hospital Plan:
- Arrange for operator to review patient as needed
- Assess for MDT involvement, for example social work, physiotherapist.
- VTE prophylaxis
- Analgesia instructions including need for on-going pain team involvement
- Advice regarding mobility, eating and drinking, urine and bowel monitoring
- Assess the need for iron or blood replacement
- Indication of length of stay required in hospital

Discharge Advice:
- Explain indications for return to hospital including increasing pain, increasing bleeding, foul discharge, and symptoms of systemic infection
- Wound cares and follow up required
- No heavy lifting for 6 weeks, initially nothing heavier than baby
- No driving for at least 2 weeks, and up to 6 weeks depending on insurance policy
- Advice regarding suitability for VBAC and least an 18-month interval between pregnancies to allow uterine healing. At same time, provide contraceptive advice, with consideration to breastfeeding
- Advise to breastfeed exclusively for at least 6 months due to maternal and fetal benefits, and mixed feeding up to a year if possible. Explain midwives are available for help and further advice with this.
- Any specific advice due to index pregnancy complications, for example regarding diabetes or hypertensive disorders of pregnancy, their implications for the postnatal period, future pregnancies, and long term maternal health.
Control group
Active

Outcomes
Primary outcome [1] 307461 0
The prevalence of EPDS-PND, defined as a score of 13 or more, in mothers at 8 weeks post-Caesarean section.
Timepoint [1] 307461 0
week 8 post-Caesarean section
Primary outcome [2] 307462 0
The incidence of mothers started on evidence-based treatment for PND, namely appropriate psychological or pharmacological therapy as outlined in the BPAC NZ article “Postnatal Depression”, in the 8 weeks following Caesarean section.
Timepoint [2] 307462 0
week 8 post-Caesarean section
Secondary outcome [1] 351972 0
prevalence of EPDS-PND in the early postnatal period based on the results of the control arm week 8 EPDS.
Timepoint [1] 351972 0
week 8 post-Caesarean section

Eligibility
Key inclusion criteria
The eligible population will be mothers of infants delivered by public Caesarean section identified from the Maternity Ward Clinical Charge Midwife’s (CCM) postnatal register.
Minimum age
16 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria will be: mothers transferred out of NSH (for example to a primary birthing unit) prior to being seen on the maternity ward; mothers not immediately admitted from the operating theatre to the maternity ward (for example those requiring admission to the intensive care unit); mothers unable to sign the operative consent form without use of an interpreter; mothers directly cared for in labour or during delivery by the study authors; mothers currently under the care of WDHB mental health services.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Phase 1 of the RCT: enrolment, recruiter assesses patient for eligibility, and excludes if ineligible. Then seeks consent from the patient to participate in the trial.

Phase 2 of the RCT: allocation, performed in real time by the recruiter after patient gives consent. This will be done using a validated randomisation app with simple randomisation technique, namely a coin toss with heads to the control group, and tails to the intervention group (random.org).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization via random.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Results for the primary outcomes will be presented using Chi-squared analysis. It is likely that this format will also be used for sub-group analysis; however, it may also be possible to use a logistic model which is preferred but cannot be confirmed until data is gathered.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
1/10/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment outside Australia
Country [1] 20850 0
New Zealand
State/province [1] 20850 0
Auckland

Funding & Sponsors
Funding source category [1] 300603 0
Self funded/Unfunded
Name [1] 300603 0
Dr Richard Carpenter
Country [1] 300603 0
New Zealand
Funding source category [2] 300732 0
Hospital
Name [2] 300732 0
North Shore Hospital, WDHB.
Country [2] 300732 0
New Zealand
Primary sponsor type
Individual
Name
Dr Richard Carpenter
Address
Waitemata District Health Board
Department of Women's Health
124 Shakespeare Rd
Takapuna
0620
Country
New Zealand
Secondary sponsor category [1] 300214 0
Hospital
Name [1] 300214 0
North Shore Hospital, WDHB.
Address [1] 300214 0
124 Shakespeare Rd, Takapuna, Auckland 0620
Country [1] 300214 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301390 0
HDEC
Ethics committee address [1] 301390 0
Ethics committee country [1] 301390 0
New Zealand
Date submitted for ethics approval [1] 301390 0
18/09/2018
Approval date [1] 301390 0
12/12/2018
Ethics approval number [1] 301390 0
Number: 18/NTB/162

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3102 3102 0 0
/AnzctrAttachments/375946-7 HDEC Application for Approval.pdf (Ethics approval)
Attachments [2] 3105 3105 0 0
/AnzctrAttachments/375946-4 WDHB Research Management Accountant Approval.pdf (Supplementary information)
Attachments [3] 3106 3106 0 0
/AnzctrAttachments/375946-Proposal 18-9-18.docx (Protocol)

Contacts
Principal investigator
Name 86842 0
Dr Richard Carpenter
Address 86842 0
Waitemata District Health Board
Department of Women's Health
124 Shakespeare Rd
Takapuna
0620
Country 86842 0
New Zealand
Phone 86842 0
+64 21 233 8867
Fax 86842 0
Email 86842 0
[email protected]
Contact person for public queries
Name 86843 0
Richard Carpenter
Address 86843 0
Waitemata District Health Board
Department of Women's Health
124 Shakespeare Rd
Takapuna
0620
Country 86843 0
New Zealand
Phone 86843 0
+64 21 233 8867
Fax 86843 0
Email 86843 0
[email protected]
Contact person for scientific queries
Name 86844 0
Richard Carpenter
Address 86844 0
Waitemata District Health Board
Department of Women's Health
124 Shakespeare Rd
Takapuna
0620
Country 86844 0
New Zealand
Phone 86844 0
+64 21 233 8867
Fax 86844 0
Email 86844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To keep data confidential.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
785Study protocol    Protocol and PIS/consent form. 375946-(Uploaded-14-12-2018-11-29-46)-Study-related document.pdf
786Ethical approval    375946-(Uploaded-14-12-2018-11-30-42)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.