Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000039785
Ethics application status
Approved
Date submitted
7/11/2021
Date registered
17/01/2022
Date last updated
17/01/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Management of secondary postpartum haemorrhage
Scientific title
Structured guidance in the management of secondary post-partum haemorrhage: A prospective cohort study involving women presenting to a single tertiary Womens' hospital.
Secondary ID [1] 305265 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
secondary post-partum haemorrhage 323548 0
endometritis 323549 0
puerperal fever 323550 0
retained products of conception 323551 0
sub fertility 323552 0
breastfeeding complications 323553 0
Condition category
Condition code
Reproductive Health and Childbirth 321107 321107 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 321108 321108 0 0
Breast feeding
Reproductive Health and Childbirth 321109 321109 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients presenting 24hours - 12 weeks following birth (>20 weeks gestation) with abnormal vaginal bleeding or retained products of conception on ultrasound will be invited to participate in a longitudinal observational study.

The clinician will enter data collected from existing medical records (without active input from participants), as well as prospectively collected data at time of the initial presentation (again without active input from the participant. Participants will then be required to complete a 10 minute online questionnaire on their health and fertility outcomes every 6 months for 36 months.

Exposures of interest:
1. Surgical management of postpartum haemorrhage (PPH)
2. Hysteroscopic treatment of retained products of conception
Intervention code [1] 321662 0
Not applicable
Comparator / control treatment
1. Medical management of secondary PPH (as comparator for surgical management)
2. Traditional curettage (suction curette and/or sharp curette, with or without ultrasound) (comparator for hysteroscopic treatment)

Similar to active participants, the clinician will enter data collected from existing medical records (without active input from participants), as well as prospectively collected data at time of the initial presentation (again without active input from the participant. Participants will then be required to complete a 10 minute online questionnaire on their health and fertility outcomes every 6 months for 36 months.
Control group
Active

Outcomes
Primary outcome [1] 329471 0
Clinical pregnancy rate.
This will be assessed using the specific study questionnaire that asks patients regarding subsequent pregnancy status (YES/NO).
Timepoint [1] 329471 0
Patients will receive the questionnaire every 6 months for 3 years after enrolment.
Primary outcome [2] 329472 0
Live birth rate.
This will be assessed using the specific study questionnaire that asks patients regarding subsequent live birth (YES/NO). (The questionnaire also asks participants to specify location and date of delivery, and consent has already been given to access subsequent pregnancy data. This location and date of delivery are not outcomes, but rather allow us to cross-reference the report of a live-birth and confirm the outcome.)
Timepoint [2] 329472 0
Patients will receive the questionnaire every 6 months for 3 years after enrolment.
Secondary outcome [1] 402727 0
Recurrent secondary PPH in a subsequent pregnancy.
This will be assessed using the specific study questionnaire that asks patients regarding Recurrent secondary PPH in a subsequent pregnancy (YES/NO).
Timepoint [1] 402727 0
Patients will receive the questionnaire every 6 months for 3 years after enrolment.
Secondary outcome [2] 402728 0
Abnormal placentation (placenta praevia, placental adhesive disorder) in a subsequent pregnancy.
This will be assessed using the specific study questionnaire that asks patients regarding abnormal placentation in a subsequent pregnancy (YES/NO). (The questionnaire also asks participants to specify location and date of delivery, and consent has already been given to access subsequent pregnancy data. This location and date of delivery are not outcomes, but rather allow us to cross-reference the report of a placental adhesive disorder and confirm the outcome.)
Timepoint [2] 402728 0
Patients will receive the questionnaire every 6 months for 3 years after enrolment.
Secondary outcome [3] 402729 0
Secondary infertility.
This will be assessed using the specific study questionnaire that asks patients regarding the diagnosis of secondary infertility (YES/NO).
Timepoint [3] 402729 0
Patients will receive the questionnaire every 6 months for 3 years after enrolment.
Secondary outcome [4] 402730 0
Cost of secondary PPH to our single institution.
This data is being assess using an audit of institution finance records coded for postnatal presentations. A case control study method will be utilised.
Timepoint [4] 402730 0
This audit will be conducted after 12months of the study being open for recruitment.
Secondary outcome [5] 402731 0
Rate of failure of initial medical management.
This is defined as representation/readmission requiring further management, with medical or surgical means.
Timepoint [5] 402731 0
An audit will be conducted at 12months, then at 12-monthly intervals until conclusion of recruitment (and 3months after the final participant is recruited).

Eligibility
Key inclusion criteria
- Delivery occurred at gestation >20.0 weeks
- Presentation to ED with secondary PPH more than 24 hours and less than 12 weeks post-partum
- Competent to provide consent
- Sufficient English language proficiency to provide written consent and complete follow-up questionnaires
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinically unfit (eg unstable) to provide consent
- Insufficient English to consent or complete questionnaires

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be collected at 6-monthly intervals for 3years following the birth complicated by the secondary PPH, with data entered into the confidential REDCap database. We plan statistical analysis to be performed using the STATA Data Analysis and Statistical Software (STATACorp, USA, Version 13). A p-value < 0.05 will be considered statistically significant for all comparisons. Association between variables will be analysed using appropriate correlation tests and logistic regression models.
We anticipate recruiting approximately 10 patients per month. This is the first prospective study examining subsequent pregnancy outcomes after secondary PPH. As such, estimates of effect on our primary outcomes are not available, and thus a sample size has not been calculated. We will recruit for 12months, then follow the cohort for 3 years.
The planned cohort sample size of 120 participants is considered feasible given calculated emergency department numbers. We hope to have follow-up data for at least 60% of these, and anticipate at least 50% will try to conceive within the follow-up time frame. This will provide some meaningful data upon which to plan future prospective studies.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
120
Accrual to date
59
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21044 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 35884 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 309635 0
Hospital
Name [1] 309635 0
Mercy Hospital for Women Ltd
Country [1] 309635 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley Road Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 310654 0
None
Name [1] 310654 0
Address [1] 310654 0
Country [1] 310654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309407 0
Mercy Hospital for Women HREC
Ethics committee address [1] 309407 0
163 Studley Road Heidelberg VIC 3084
Ethics committee country [1] 309407 0
Australia
Date submitted for ethics approval [1] 309407 0
Approval date [1] 309407 0
18/09/2020
Ethics approval number [1] 309407 0
2020-042

Summary
Brief summary
The spectrum of illness in secondary PPH is vast. While some patients experience severe bleeding with haemodynamic instability, or even maternal death, more commonly the vaginal bleeding is less than with a primary PPH. However, the morbidity is still considerable, with many women requiring blood transfusion and surgical interventions such as hysterectomy (Hoveyda & MacKenzie, 2003). Breastfeeding, newborn bonding, and peripartum mental health are also impacted when prolonged inpatient care or repeated outpatient reviews are required.

There are no randomised controlled trials or other high-quality research data to guide best management for women who present with a secondary PPH (Mavrides et al, 2016). With the exception of certain antibiotic regimes for postnatal endometritis, current management options for secondary PPH are, at best, based on Level 3 and Level 4 evidence. As such, most institutions and professional bodies do not have a specific policy or guideline to assist clinicians managing this relatively common complication, nor are there audit systems in place to assess safety and success of management.

This prospective project aims to recruit women attending a single institution for the management of secondary PPH. This women will have baseline antenatal, intrapartum and postnatal data entered and then be invited to participate in a longitudinal study collecting survey-based data every 6months for 36months. A nested cohort study will arise from the patients managed surgically (group managed with traditional suction curette, compared to those managed hysteroscopically).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114050 0
Dr Samantha Mooney
Address 114050 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 114050 0
Australia
Phone 114050 0
+61 3 84584022
Fax 114050 0
+61 3 84584889
Email 114050 0
samantha.mooney39@gmail.com
Contact person for public queries
Name 114051 0
Dr Samantha Mooney
Address 114051 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 114051 0
Australia
Phone 114051 0
+61 3 84584022
Fax 114051 0
Email 114051 0
samantha.mooney39@gmail.com
Contact person for scientific queries
Name 114052 0
Dr Samantha Mooney
Address 114052 0
Mercy Hospital for Women
163 Studley Road
Heidelberg VIC 3084
Country 114052 0
Australia
Phone 114052 0
+61 3 84584022
Fax 114052 0
Email 114052 0
samantha.mooney39@gmail.com

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.