Sildenafil in Sever Intrauterine Growth Retardation

NCT03153215 | Completed DMC

• 1 other identifier: Beni-Suef 12
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intra-Uterine Growth Retardation

Outcome Measures

Primary Outcomes (3)

• Umbilical artery Pulsatility index

  Change in umbilical artery pulsatility index after medication

  between 24 gestational weeks until 36 weeks

• Middle cerebral artery Pulsatility index

  Change in middle cerebral artery pulsatility index after medication

  between 24 gestational weeks until 36 weeks

• 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 Outcomes (2)

• Rate of drug side effects

  between 24 and 36 gestational weeks

• Birth weight

  between 24 and 36 gestational weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

women with severe IUGR

Other: treatment

Control group

ACTIVE COMPARATOR

women with severe IUGR

Other: Placebo

Interventions

treatment OTHER

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.

Intervention group

Placebo OTHER

Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.

Control group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• known aneuploid anomaly, syndrome congenital infection.
• If there is a plan to terminate the pregnancy.

Sponsors & Collaborators

• Beni-Suef University: lead
• Cairo University: collaborator

Study Sites (1)

Beni-Suef University

Cairo, Beni Suweif Governorate, 12412, Egypt

Location

Related 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. doi: 10.1016/j.ajog.2006.05.021. Epub 2006 Oct 2.

  PMID: 17014813 BACKGROUND

• 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.

  PMID: 24007710 BACKGROUND

• 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. doi: 10.1111/j.1749-6632.2001.tb03813.x.

  PMID: 11594552 BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

• Nesreen A Shehata, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will randomly be allocated to two groups with 23 patients in each group
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Model Details: A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a randomized placebo control controlled study . Patients will randomly be allocated to two groups with 23 patients in each group

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 15, 2017
• Study Start: May 6, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)