A randomised controlled trial of sulindac to delay premature birth in pregnancies complicated by a short cervix
The Royal Women's Hospital
40 participants
Nov 16, 2017
Interventional
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
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 18 and 23+6 weeks of pregnancy.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12617001639314