None listed
Conditions
Brief summary
This study aims to assess whether sulindac therapy (100mg TWICE daily orally for 14 days) prolongs gestation in women with a cervical length of <15 mm on transvaginal sonography between 18 and 23+6 weeks of pregnancy.
Interventions
The aim of this project is to determine whether a medicine given during pregnancy can help to delay or prevent premature birth. This may reduce health complications in the newborn baby that can occur by being born too early.
Sulindac (Aclin®) is a medicine belonging to a group of medicines called non-steroidal anti-inflammatories (NSAIDS).
Sulindac 100mg will be given orally twice daily for 14 days to prolong gestation in women with a cervical length of <15 mm on transvaginal sonography between
The aim of this project is to determine whether a medicine given during pregnancy can help to delay or prevent premature birth. This may reduce health complications in the newborn baby that can occur by being born too early. Sulindac (Aclin®) is a medicine belonging to a group of medicines called non-steroidal anti-inflammatories (NSAIDS). Sulindac 100mg will be given orally twice daily for 14 days to prolong gestation in women with a cervical length of <15 mm on transvaginal sonography between 18 and 23+6 weeks of pregnancy.
Sponsors
The Royal Women's Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Age 18-45 -Gestation 18+0/40 - 23+6/40 weeks by EDD established according to RWH guidelines -Consent to sonographic estimation of AFI (Amniotic Fluid Index) scores -Cervical length 0-15mm on transvaginal ultrasonography, performed using a standardised technique14 -Singleton pregnancy -Has received treatment with vaginal progesterone pessaries -Has received treatment with cervical cerclage -Has been submitting to recommended ‘bed rest’
Exclusion criteria
-Gestation outside 18+0/40 - 23+6/40 week range -Multiple pregnancy -Cervical length greater than 15mm -Known allergy to sulindac -Pre-existing oligohydramnios / AFI <10 cm -Pre-existing clinical chorioamnionitis -Inability to provide informed consent -History of any contraindications to NSAIDS, including: acute dehydration, NSAID-sensitive asthma, coagulation disorders, heart failure, active peptic ulcer disease or GI bleeding, renal impairment / CrCl<25mL/min.
Outcome results
None listed