Sildenafil therapy in dismal prognosis early-onset intrauterine growth restrictio

Phase 3

Completed

• Conditions: Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth; Pregnancy and Childbirth

• Registration Number: ISRCTN39133303
• Lead Sponsor: iverpool Women's NHS Foundation Trust (UK)

Brief Summary

1. 2014 protocol in https://www.ncbi.nlm.nih.gov/pubmed/24618418 2. 2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/29282009 3. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30169244

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-31
• Study Completion: 2016-07-31
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

1. Women with singleton pregnancy and fetus diagnosed with severe, early onset intrauterine growth restriction (IUGR) between 22+0 and 29+6 weeks of gestation and clinical decision to manage pregnancy expectantly.
2. IUGR is defined as estimated fetal weight or abdominal circumference <10th centile and absent or reversed end diastolic velocity Doppler in the umbilical artery.
3. 16 years of age or older
4. Consent to take part in the trial

Exclusion Criteria

1. Multiple pregnancy
2. Known or suspected structural or chromosomal fetal abnormality
3. Maternal illness (e.g., pre-eclampsia) that is expected to require delivery for maternal reasons within the next 72 hours
4. Maternal wish not to have active management of the pregnancy, or to have pregnancy termination weeks
5. Inability to give informed consent
6. Cocaine use
7. Contraindication to sildenafil therapy, e.g., known maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil

Study & Design

• Study Type: Interventional
• Study Design: Not specified