A randomised controlled trial of sulindac to delay premature birth in pregnancies complicated by a short cervix

Recruiting

• Conditions: Short cervix; Premature birth; pregnancy; Reproductive Health and Childbirth - Antenatal care

• Registration Number: ACTRN12617001639314
• Lead Sponsor: The Royal Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-18
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified