A feasibility study investigating pravastatin for the prevention of preterm birth in wome

Not Applicable

Completed

• Conditions: Preterm labour; Pregnancy and Childbirth

• Registration Number: ISRCTN82984919
• Lead Sponsor: The University of Edinburgh and/or Lothian Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-15
• Study Completion: 2019-11-29
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

Current participant inclusion criteria as of 17/06/2019:
1. Aged 16 years or above
2. Singleton pregnancy
3. Gestation =24+0 and =35+6 weeks (based on dating scan obtained at =16 weeks gestation)
4. Not previously recruited to this study in this pregnancy
5. Intact membranes
6. A positive fetal fibronectin test OR a short cervical length (=15 mm) on ultrasound examination OR cervical dilation =3 cm and less than fully dilated
7. Uterine activity defined as =1 palpable contraction over 20 minutes of CTG monitoring.
8. No major congenital anomalies evident on the 20-week anomaly scan, or any further anomaly scans performed subsequently. If an anomaly is present, this should be classified as per ICD-10 codes and minor anomalies discussed for inclusion on a case by case approach involving the clinical team, the PI and the participant.

Previous participant inclusion criteria:
1. Aged 16 years or above
2. Singleton pregnancy
3. Gestation =28+0 and =35+6 weeks (based on dating scan obtained at =16 weeks gestation)
4. Not previously recruited to this study in this pregnancy
5. Intact membranes
6. A positive fetal fibronectin test OR a short cervical length (=15 mm) on ultrasound examination OR cervical dilation =3 cm and less than fully dilated
7. Uterine activity defined as =1 palpable contraction over 20 minutes of CTG monitoring.
8. No major congenital anomalies evident on the 20-week anomaly scan, or any further anomaly scans performed subsequently. If an anomaly is present, this should be classified as per ICD-10 codes and minor anomalies discussed for inclusion on a case by case approach involving the clinical team, the PI and the participant.

Exclusion Criteria

1. Immediate delivery deemed necessary for fetal or maternal reasons as determined by a senior clinician
2. Pre-labour, preterm rupture of membranes in the index pregnancy
3. Obstetric cholestasis as defined by RCOG (RCOG Green-Top Guideline, Number 43)
4. Established severe pre-eclampsia or HELLP syndrome as defined by NICE guidance (Hypertension in pregnancy: diagnosis and management | Guidance and guidelines | NICE n.d.)
5. Known history of hepatic or renal impairment
6. Ingestion of drugs thought to alter the pharmacokinetics or efficacy of statins, including erythromycin and/or nifedipine
7. Taking any one of the prohibited drugs as listed the SmPC and in 5.7.3
8. Lactose intolerance (due to excipient in pravastatin and placebo tablets)
9. Current or previous alcohol misuse
10. Personal or first degree relative with heritable muscle disorders
11. Participating in another CTIMP trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified