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Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment

Sponsor
Ain Shams University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03230162
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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
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)

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2017
Anticipated Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
May 1, 2018

Arms and Interventions

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 Names:
  • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neonatal birth weight in grams [At time of Delivery]

    Secondary Outcome Measures

    1. The change in Doppler velocity indices, [24 week till 35 weeks]

    2. Fetal growth velocity [weekly till time of delivery]

    3. Gestational age at delivery, [at time of delivery]

    4. APGAR score [at 1 and 5 min of life]

    5. Neonatal complication rates [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 [The first 28 day of delivery]

    7. the interval between the diagnosis and delivery [at time of delivery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AinShams university maternity hospital Cairo Egypt 02

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 26, 2017
    Last Update Posted:
    Jul 26, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fetal Growth Retardation
    Heparin
    Heparin, Low-Molecular-Weight
    Tinzaparin
    Dalteparin
    Sildenafil Citrate

    Study Results

    No Results Posted as of Jul 26, 2017