Platform trials

Research studies in the field of preterm birth that are being discussed and promoted at the conference. Each platform trial will have a stand and a 10 minute oral presentation where you can find out more. 


ABOVE

Transvaginal cervical cerclage (TVC) reduces risk of spontaneous preterm birth (sPTB) in high-risk
women. However, retrospective studies show that they may not be as effective (ten-fold less) in
women who have had a spontaneous preterm birth following a caesarean section in labour. For these
women, transabdominal cerclage (TAC) may be more effective, although this procedure is more
invasive.

This study will assess whether transvaginal or transabdominal cerclage is more effective in women
who have had a preterm birth (before 30 weeks) or mid-trimester loss (between 14 and 24 weeks)
after a previous caesarean section in labour. Participants will be allocated to either group A or group B
depending on whether they are already pregnant or planning a pregnancy. They will then be
randomised to receive either TVC or TAC.

 

CSTICH 2

CSTICH2 is a randomised controlled trial in women who present with exposed, unruptured membranes in the second trimester of pregnancy. Women are approached to be randomised to either expectant management or emergency cervical cerclage placement.

The project included a 24-month pilot phase with a nested qualitative study designed to explore the feasibility, acceptability, and appropriateness of the intervention for women and health workers. The pilot study ended in January 2021 (delayed due to Covid-19 pandemic) with 24 women recruited and randomised. The qualitative study ended in November 2020. The results from the qualitative study have been incorporated into study plans moving forward. Following  the end of the pilot, the study was adapted to include an observational cohort in addition to the Randomised Controlled Trial (RCT).

The study is open in 34 maternity units across England, Wales and Scotland and recruitment ends on 31st October 2024.

 

Nordic randomized trial on laparoscopic versus vaginal cerclage – NORACT

Both vaginal and abdominal cerclages are procedures that have been used to prevent preterm birth for more than 50 years. However, only one previous study (MAVRIC, Shennan et al. 2020) has compared the two methods in a
randomised trial. Other than evidence from the MAVRIC trial there is uncertainty whether an abdominal cerclage should be preferred over vaginal cerclage, and which women would benefit from it the most.

NORACT is an open, multicenter, superiority, randomized controlled trial with the overall objective to compare laparoscopic versus vaginal cerclage in woman in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth. Participants will be recruited pre-pregnancy or in early pregnancy and randomised to vaginal or laparoscopic cerclage. If randomised to laparoscopic cerclage this will be inserted pre-pregnancy or before 10+0 weeks of gestation. The vaginal cerclage will be inserted during pregnancy, before 16+0 weeks of gestation. A total sample of 188 participants will be included to detect a target difference of 15% in the primary outcome between the two groups. The primary outcome is delivery before 32+0 weeks of gestation and the key secondary outcome is baby death. The study extends from sites in Denmark, Sweden, Norway, Finland, Iceland, and the United Kingdom.

 


PIONEER (Pravastatin tO preveNt prEtErm biRth)

PIONEER (Pravastatin tO preveNt prEtErm biRth) is an NIHR/MRC EME funded multi-site parallel group placebo-controlled RCT to investigate whether Pravastatin reduces the risk for preterm birth (PTB) in those identified as being at moderate or high risk. PIONEER is coordinated by the Bristol Trials Centre and with co-applicants from across the UK Preterm Clinical Network.

Our research questions are:
Is Pravastatin better than placebo at extending gestational length of pregnancy?
If so, does Pravastatin have this effect through changes to the cervicovaginal inflammatory profile, vaginal and gut microbiota or serum lipids?

Our aims and objectives are:
Evaluate the efficacy of Pravastatin versus placebo in reducing PTB in those at risk:
Assess difference between groups in mean GA (days) at birth;
Estimate difference between groups with respect to a range of secondary outcomes.
Investigate mechanisms via which Pravastatin prevents PTB by assessing the effect of Pravastatin vs placebo on maternal:
Cervicovaginal inflammatory profile;
Vaginal and gut microbiota;
Serum lipid profile.

750 participants will be randomised to take either 20mg Pravastatin every day, from the 2nd trimester until 37+0 weeks or birth, or placebo. The primary outcome is gestational age at birth in days, and we will also measure a pre-defined maternal and neonatal core set for evaluation of PTB prevention interventions, and a childhood assessment at 2 years corrected age via the PARCA-R questionnaire.

In addition, for a sub-group of 250 participants, we will assess maternal:
Cervicovaginal fluid inflammatory profile;
Vaginal microbiota profile;
Serum lipid profile;
Stool microbiota profile.

We will start recruitment in April 2024, and will complete recruitment in Spring 2027. We are keen to include recruitment sites from across the UK.

 


STOPPIT 3- A Randomised Placebo-Controlled Trial of Antenatal Corticosteroids for Planned Birth in Twins: STOPPIT-3

This NIHR funded portfolio trial aims to find out if antenatal corticosteroids (ACS) given to women with a twin pregnancy prior to planned birth of twins reduces breathing difficulties in the twin babies.

We are open to new sites and keen to support PIs and research teams in all settings who want to become involved in large scale, practice-shaping research.

Please visit our website for more details: www.stoppitstudy.co.uk