NCT03230162

Brief Summary

comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

May 28, 2017

Last Update Submit

July 23, 2017

Conditions

Fetal Growth AbnormalityFetal Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • Neonatal birth weight in grams

    At time of Delivery

Secondary Outcomes (7)

  • The change in Doppler velocity indices,

    24 week till 35 weeks

  • Fetal growth velocity

    weekly till time of delivery

  • Gestational age at delivery,

    at time of delivery

  • APGAR score

    at 1 and 5 min of life

  • Neonatal complication rates

    The first 28 day of delivery

  • +2 more secondary outcomes

Study Arms (2)

sildenafil citrate

EXPERIMENTAL

50 pregnant female will be treated with sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery.

Drug: Sildenafil

low molecular weight heparin

EXPERIMENTAL

50 pregnant female will be treated with a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery according to body weight as follow \< 50 kg 3500 units daily 50-90 kg 4500 units daily 91-130 kg 7000 units daily 131-170 kg 9000 units daily \> 170 kg 75 u/kg/day

Drug: low molecular weight heparin

Interventions

SildenafilDRUG

sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery

Also known as: Silden EIPICO co.
sildenafil citrate
low molecular weight heparinDRUG

a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery

Also known as: tinzaparin, Innohep LEO pharmaceutical products
low molecular weight heparin

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal age between 20-35 years.
  • Being at a gestational age 28-35wks.
  • Singleton pregnancy.
  • Fetal growth restriction diagnosed by ultrasound with estimated fetal weight below the 10th percentile, and/or fetal abdominal circumference at or below the tenth percentile.

You may not qualify if:

  • Maternal age less than 20 years or more than 35 years.
  • Undetermined gestational age.
  • Multiple gestation.
  • Chronic diseases with pregnancy e.g. Chronic hypertension, diabetes type 1 or 2.
  • Etiologies of FGR other than placental insufficiency as fetal malformations, aneuploidy or infections.
  • Suspected fetal compromise requiring emergency delivery.
  • Any contraindication to the use of sildenafil e.g. known significant maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil.
  • Any contraindication to the use of LMWH e.g. known bleeding disorder, active antenatal bleeding or at increased risk of major hemorrhage (e.g. placenta praevia), thrombocytopenia, severe renal or hepatic disease.
  • Drug or alcohol abuse.
  • Patient refusing to participate in the study or unable to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Sildenafil CitrateHeparin, Low-Molecular-WeightTinzaparin

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Radwa R Ali, MD

CONTACT

01283492979radwaebed@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

May 28, 2017

First Posted

July 26, 2017

Study Start

June 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

EG(1)