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Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03230162
Recruitment Status : Unknown
Verified July 2017 by Radwa Rasheedy Ali, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Radwa Rasheedy Ali, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Fetal Growth Abnormality Fetal Growth Restriction Drug: Sildenafil Drug: low molecular weight heparin Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sildenafil citrate
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
sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery
Other Name: Silden EIPICO co.

Experimental: low molecular weight heparin
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
a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery
Other Names:
  • tinzaparin
  • Innohep LEO pharmaceutical products




Primary Outcome Measures :
  1. Neonatal birth weight in grams [ Time Frame: At time of Delivery ]

Secondary Outcome Measures :
  1. The change in Doppler velocity indices, [ Time Frame: 24 week till 35 weeks ]
  2. Fetal growth velocity [ Time Frame: weekly till time of delivery ]
  3. Gestational age at delivery, [ Time Frame: at time of delivery ]
  4. APGAR score [ Time Frame: at 1 and 5 min of life ]
  5. Neonatal complication rates [ Time Frame: The first 28 day of delivery ]
    respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion

  6. Neonatal ICU admission rate [ Time Frame: The first 28 day of delivery ]
  7. the interval between the diagnosis and delivery [ Time Frame: at time of delivery ]


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230162


Contacts
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Contact: Radwa R Ali, MD 01283492979 ext +202 radwaebed@yahoo.com

Locations
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Egypt
AinShams university maternity hospital Recruiting
Cairo, Egypt, 02
Contact: Radwa R Ali, MD         
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Radwa Rasheedy Ali, lecturer of obstetrics and gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03230162    
Other Study ID Numbers: Ain shams university maternity
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Tinzaparin
Sildenafil Citrate
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents