Sildenafil in Sever Intrauterine Growth Retardation

Intra-Uterine Growth Retardation Clinical Trial

— IUGR  

Official title:

Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153215
• Other study ID #: Beni-Suef 12
• Status: Completed
• Phase: N/A
• Start date: May 6, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2018
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.

Description:

The aim of our study is to evaluate the effect of sildenafil citrate therapy on severe early and late onset intrauterine growth retardation.A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a prospective case control study .

Patients will randomly be allocated to two groups with 23 patients in each group.Sildenafil citrate therapy may increase the likelihood of increased growth velocity [measured by abdominal circumference (AC) (ultrasound)] for fetuses of pregnancies complicated by severe early-onset IUGR .Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP which results in increased levels of cGMP, leading to smooth muscle relaxation. Placental disease, consequent on deficient uteroplacental blood flow, includes FGR, pre-eclampsia, and placental abruption and has been implicated in more than 50% of iatrogenic premature births .For this reason, the problem of severe FGR forms a substantial portion of the population that tertiary care centres care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

• pregnancy complicated by severe IUGR [abdominal circumference (AC)< 5th percentile] the gestational age <25 weeks or an estimate of the fetal weight was <600 gm (excluding known fetal anomaly/syndrome and/or planned termination) ( von Dadelszen.et al;2011).

Exclusion Criteria:

• known aneuploid anomaly, syndrome congenital infection.

• If there is a plan to terminate the pregnancy.

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intra-Uterine Growth Retardation

Intervention

Other:
• treatment
We will offer Sildenafil citrate (20 mg per os three times daily until delivery) as innovative therapy to 23 women with severe IUGR ('Sildenafil-treated') in addition to fish oil and zinc supplementation.
• Placebo
Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Cairo	Beni-Suef

Sponsors (2)

Lead Sponsor	Collaborator
Beni-Suef University	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Ananth CV, Vintzileos AM. Maternal-fetal conditions necessitating a medical intervention resulting in preterm birth. Am J Obstet Gynecol. 2006 Dec;195(6):1557-63. Epub 2006 Oct 2. — View Citation

Lausman A, Kingdom J; MATERNAL FETAL MEDICINE COMMITTEE. Intrauterine growth restriction: screening, diagnosis, and management. J Obstet Gynaecol Can. 2013 Aug;35(8):741-748. doi: 10.1016/S1701-2163(15)30865-3. English, French. — View Citation

Lee MJ, Conner EL, Charafeddine L, Woods JR Jr, Del Priore G. A critical birth weight and other determinants of survival for infants with severe intrauterine growth restriction. Ann N Y Acad Sci. 2001 Sep;943:326-39. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Umbilical artery Pulsatility index	Change in umbilical artery pulsatility index after medication	between 24 gestational weeks until 36 weeks
Primary	Middle cerebral artery Pulsatility index	Change in middle cerebral artery pulsatility index after medication	between 24 gestational weeks until 36 weeks
Primary	fetal abdominal circumference growth velocity	proportion of women in each group for whom fetal AC growth velocity will change post randomization.	between 24 gestational weeks until 36 weeks
Secondary	Rate of drug side effects	Women in the Sildenafil-treated group will be also monitored for adverse side-effects, such as flushing, lightheadedness and visual disturbance	between 24 and 36 gestational weeks
Secondary	Birth weight	weight of neonate at birth in grams	between 24 and 36 gestational weeks