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Trial registered on ANZCTR

Registration number

ACTRN12622000753752

Ethics application status

Approved

Date submitted

5/04/2022

Date registered

26/05/2022

Date last updated

26/05/2022

Date data sharing statement initially provided

26/05/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Viral mitigation measures and preterm birth rate in high risk pregnant women

Scientific title

A pilot feasibility randomised controlled trial investigating the effect of viral transmission mitigation measures on the incidence of preterm birth in high-risk pregnant women.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Rolnik, D.L., Matheson, A., Liu, Y., Chu, S., Mcgannon, C., Mulcahy, B., Malhotra, A., Palmer, K.R., Hodges, R.J. and Mol, B.W. (2021), Impact of COVID-19 pandemic restrictions on pregnancy duration and outcome in Melbourne, Australia. Ultrasound Obstet Gynecol, 58: 677-687. https://doi.org/10.1002/uog.23743

The study was not registered in any trial registries given it was an observational, retrospective study. Our trial is a follow up to this study.

Health condition

Health condition(s) or problem(s) studied:

Preterm birth

COVID-19

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Infection

Other infectious diseases

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The research team alongside research midwives will recruit pregnant women from the antenatal clinic at Monash Medical Centre who are high risk for having a preterm birth, where high risk will be defined as women who have had a previous preterm birth.

We will randomise these women to the 'intervention' and 'control' groups. The control group will undergo standard pregnancy care without any changes.

Women who are randomised to the 'intervention' group will be asked to comply with a set of viral mitigation measures, similar to those introduced in the in the stage 3 and 4 SARS-CoV-2 lockdowns in Melbourne, Australia.

Participants in the intervention group will be asked to comply with the following for the duration of the study:
1. Study participants should attempt to maintain social distancing where possible. They should refrain from leaving their homes unless required to do so,
such as shopping for essentials, to work or study, to seek/give care or for outside exercise. Study participants allocated to the intervention arm should
avoid having visitors to their home, unless it is their intimate partner. Study participants should try to maintain 1.5m distance between themselves and
another party unless in their own home or with an intimate partner.
2. Study participants will be instructed to wear a face mask/covering when outside their home and perform hand hygiene prior to removing their
mask/touching any aspect of their nose or mouth.
3. Study participants should aim to remain at home between the hours of 9pm and 5am unless they are required to leave for work/study or to seek/give
care, and should avoid travelling beyond 5km of their place of residence.

Participants will be recruited two weeks prior to the gestational age at which the study participant’s previous preterm birth occurred (i.e. if someone delivered in her previous pregnancy at 32+3 weeks, the intervention will start at 30+3 weeks). It will be conducted for six weeks (i.e two weeks prior and four weeks post the gestational age of the previous preterm birth) or until 34 weeks of gestation or until birth, whichever comes first.

Participants will be required to complete short surveys (which will be developed through Qualtrics XM) to assess their compliance with viral mitigation measures, activities, mood and quality of life at baseline and then on a fortnightly basis for the duration of the study.

Intervention code [1]

Prevention

Comparator / control treatment

Women randomised to the control group will undergo standard pregnancy care without any changes. The research team will not ask them comply with any viral mitigation measures.

Standard pregnancy care involves between 2-4 weekly antenatal appointments, antenatal screening pathology (e.g serology testing, blood group, iron studies, vitamin D level), ultrasound scans, vaccinations (Pertussis, COVID-19 vaccination), growth scans if indicated in specific patient populations (e.g those with risk factors for fetal growth restriction), vaginal swabs (Group B Strep screening) etc.

We will ask them to complete fortnightly surveys to assess which viral mitigation measures they are still following of their own accord given the SARS-CoV-2 pandemic is still ongoing, mood, quality of life, sleep and other activities.

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome: Feasibility of this study.
We will measure feasibility using the following criteria alongside targets that will establish whether a larger trial would be feasible to conduct:

Patient eligibility rate
o Measured as the proportion of eligible women screened at Monash Medical Centre’s Antenatal Clinics who are expected to consent to taking part in this trial
o We will set a target of at least 50%

Patient recruitment rate
o The proportion of eligible pregnant women who are recruited and randomized
o We will set a target of at least 50%

Compliance rate
o The proportion of participants in the intervention group who are considered to have good compliance with the intervention
o Compliance will be measured using subjective (fortnightly surveys) measures.
o We will set a target of at least 75%.

Data completion rate
o This will be measured as the proportion of final surveys completed (i.e the survey that is conducted after the end of the intervention)
o We will set a target of at least 75%.

Data will be collected from patient's medical recods and via fortnightly surveys conducted throughout the intervention period.

Timepoint [1]

Patient eligibility rate
o This will be measured following the recruitment of 100 women to the study.

Patient recruitment rate
o This will be measured following the recruitment of 100 women to the study.

Compliance rate
o This will be measured via surveys at baseline (i.e before the participant begins the study) and then on a fortnightly basis until the end of the study.

Data completion rate
o This will be measured as the proportion of final surveys completed (i.e the survey that is conducted after the end of the study).

Secondary outcome [1]

Incidence of preterm birth (<34 weeks)

Timepoint [1]

This will be measured when the patient gives birth by accessing their medical records (data-linkage).

Secondary outcome [2]

Maternal quality of life

Timepoint [2]

This will be measured at baseline and then on a fortnightly basis throughout the intervention via surveys. The survey for this study was designed specifically for this study by the research team based on other validated pregnancy questionnaires including the Beck Depression Inventory , Edinburgh Postnatal Depression Scale, QOL GRAV, EQ-5D-3L and the Multidimensional Scale of Perceived Social Support.

Secondary outcome [3]

Pregnancy duration

Timepoint [3]