Back to resultsSildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
Primary Purpose
Fetal Growth Abnormality, Fetal Growth Restriction
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil
low molecular weight heparin
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Growth Abnormality
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- AinShams university maternity hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
sildenafil citrate
low molecular weight heparin
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Neonatal birth weight in grams
Secondary Outcome Measures
The change in Doppler velocity indices,
Fetal growth velocity
Gestational age at delivery,
APGAR score
Neonatal complication rates
respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion
Neonatal ICU admission rate
the interval between the diagnosis and delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03230162
Brief Title
Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
Official Title
Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Anticipated)
Study Completion Date
May 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due to placental insufficiency
Detailed Description
One hundred pregnant women with documented intrauterine growth restriction due to placental insufficiency at 28-35 weeks of gestation will be distributed into two groups:
Group S: 50 women will receive Sildenafil citrate 25 mg tab 3 times daily.
Group H: 50 women will receive single dose of LMWH subcutaneous daily.
Both groups will undergo strict fetal surveillance in the form of:
Umbilical artery Doppler (UAD) is the primary surveillance tool in the FGR fetus:
middle cerebral artery (MCA) Doppler, ultrasound for (AC, EFW, and deepest vertical pocket (DVP) for amniotic fluid) and non stress test and Biophysical profile (BPP)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Abnormality, Fetal Growth Restriction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sildenafil citrate
Arm Type
Experimental
Arm Description
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.
Arm Title
low molecular weight heparin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Silden EIPICO co.
Intervention Description
sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery
Intervention Type
Drug
Intervention Name(s)
low molecular weight heparin
Other Intervention Name(s)
tinzaparin, Innohep LEO pharmaceutical products
Intervention Description
a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery
Primary Outcome Measure Information:
Title
Neonatal birth weight in grams
Time Frame
At time of Delivery
Secondary Outcome Measure Information:
Title
The change in Doppler velocity indices,
Time Frame
24 week till 35 weeks
Title
Fetal growth velocity
Time Frame
weekly till time of delivery
Title
Gestational age at delivery,
Time Frame
at time of delivery
Title
APGAR score
Time Frame
at 1 and 5 min of life
Title
Neonatal complication rates
Description
respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion
Time Frame
The first 28 day of delivery
Title
Neonatal ICU admission rate
Time Frame
The first 28 day of delivery
Title
the interval between the diagnosis and delivery
Time Frame
at time of delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa R Ali, MD
Phone
01283492979
Ext
+202
Email
radwaebed@yahoo.com
Facility Information:
Facility Name
AinShams university maternity hospital
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radwa R Ali, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
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