None listed
Conditions
Brief summary
On March 11th, 2020, the World Health Organization declared the outbreak of SARS-CoV-2 to be a pandemic. With case numbers rising sharply, Australian state and territory governments began introducing restriction measures including limitations on social gatherings, closure of non-essential services and social distancing rules with the aim of mitigating spread of the virus. The Victorian state government imposed a less stringent set of restrictions in March 2020, followed by a period of eased restricted and then a second, harsher set of restrictions in July 2020. It has been observed that there has been a reduction in the rate of preterm birth in women exposed to restriction measures implemented to mitigate SARS-CoV-2 transmission; an effect that is more pronounced in women who have previously experienced a preterm birth. We propose a two-arm randomized controlled feasibility clinical trial to be conducted in Monash Medical Centre (Melbourne, Australia). We will study pregnant women who are enrolled in the antenatal clinics and who have previously had a preterm birth (<34 weeks). Eligible participants will be randomized into two groups: the intervention group, where participants will be required to adhere to restriction measures originally imposed to mitigate transmission of the SARS-CoV-2 virus until birth or the control group, where participants will undergo standard pregnancy care. The primary outcome of this trial will be feasibility, which will be assessed by measuring patient eligibility rate, recruitment rate, compliance rate and data completion rate. The secondary outcome measures of this trial will be the rate of preterm birth (<34 weeks), maternal quality of life and pregnancy outcomes. We will aim to recruit up to 100 pregnant women, 50 of whom will be randomized to the intervention and 50 of whom will be randomized to the control group. The aim of this study is to establish feasibility and we acknowledge that the sample size is not significant enough to prove an effect on the rate of preterm birth. This study will establish a foundation upon which to conduct a larger randomized controlled trial, investigating the effects of restriction measures on the reduction of the rate of preterm birth and therefore play a role in preventing the significant health and economic consequences of preterm birth.
Interventions
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 vira
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.
Sponsors
Monash Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pregnant women (singleton or multiple gestation) who are at ‘high risk’ of having a preterm birth where ‘high-risk’ will be defined as pregnant women who have had a previous preterm birth (<34 weeks), either spontaneously or due to iatrogenic delivery.
Exclusion criteria
We will exclude pregnant women carrying a foetus with one or more major congenital abnormalities. We will exclude any pregnant women under the age of 18. We will exclude pregnant women carrying a multiple gestation who have not had a previous preterm birth.
Outcome results
None listed