High Risk PregnancyNCT04110444
Sildenafil Citrate Added to Low Molecular Weight Heparin and Low Dose Aspirin in High-risk Pregnancy
An observational study of High Risk Pregnancy, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Anticoagulant therapy is indicated during pregnancy for the prevention and treatment of venous thromboembolism, systemic embolism in patients with mechanical heart valves and, in combination with aspirin, for the prevention of recurrent pregnancy loss in women with antiphospholipid antibodies Sildenafil citrate… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk Pregnancy
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: high-risk pregnant women of gestational age 28-37 weeks women with current preeclampsia, IUGR and oligohydramnios
Who may be able to join
- high-risk pregnant women (women with current preeclampsia, IUGR and oligohydramnios)
- gestational age 28-37 weeks
- no major medical illness contraindicating sildenafil use (cardiovascular disease, sickle cell anaemia, retinopathy, hearing loss, liver diseases)
- willingness to sign informed consent for study randomization
Who cannot join
- gestational age less than 28 weeks
- refusal of Doppler studies or sildenafil use
- contraindication or allergy to sildenafil
- those who can't present for monitoring visits or follow medication instructions
- those with major medical illness including cardiovascular disease and diabetes mellitus
- multiple pregnancies
Show all 10Show fewer
- suspected chromosomal or fetal congenital anomalies (documented by level II ultrasound examination)
- users of any vasodilator agents
- those who had maternal or fetal emergencies necessitating delivery at time of recruitment in the study or with diastolic blood pressure more than 110 mmHg
- BMI is more than 34 that would impede accurate measurement of fetal biometry and Doppler parameters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sildenafil Citrate Added to Low Molecular Weight Heparin and Low Dose Aspirin to Improve Uteroplacental Perfusion in High-risk Pregnancy
Anticoagulant therapy is indicated during pregnancy for the prevention and treatment of venous thromboembolism, systemic embolism in patients with mechanical heart valves and, in combination with aspirin, for the prevention of recurrent pregnancy loss in women with antiphospholipid antibodies Sildenafil citrate increases uterine blood flow and potentiates estrogen-induced vasodilatation. Intravaginal administration of Sildenafil in the success of in vitro fertilization describes no deleterious effects on mother and fetus
Read the detailed description
Pregnancy is considered an acquired hypercoagulable state due to increased concentration of coagulation factors, decreased levels of anticoagulants and decreased fibrinolytic capacity. Adverse pregnancy outcomes affect up to 15% of gestations and are the major cause of maternal and fetal morbidity and mortality. A poor perinatal outcome is expected in pregnancies with high vascular resistance in uterine circulation, but the pregnancies in which the resistance values are normalized in the later trimesters have a significantly better outcome.
For the prevention of fetal growth restriction, a recent large-study level meta-analysis and individual patient data meta-analysis confirm that aspirin modestly reduces small-for-gestational-age pregnancy in women at high risk (relative risk, 0.90, 95% confidence interval, 0.81-1.00) and that a dose of ≥100 mg should be recommended and to start at or before 16 weeks of gestation. Moreover, in vitro and in vivo studies suggest that low-molecular-weight heparin may prevent fetal growth restriction; however, evidence from randomized control trials is inconsistent.
In a normal pregnancy, the trophoblast produces nitric oxide (NO) which plays an important role in vasodilatation in the fetoplacental circulation to improve oxygen and nutritional supply to the fetus (9,10). Nitric oxide relaxes arterial and venous smooth muscle potently and might inhibit platelet aggregation and adhesion. Moreover, increased circulating phosphodiesterase (PDE) activity is suspected in women with preeclampsia. In pregnancies with fetal growth restriction and without preeclampsia, a reversible increased myometrial arterial tone by phosphodiesterase inhibition has been reported in vitro.
Phosphodiesterase type 5 inhibitors that potentiate nitric oxide availability such as sildenafil citrate have been extensively researched both in preclinical and clinical studies; Sildenafil citrate is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase (PDE)-5 leading to cyclic guanosine monophosphate (cGMP) accumulation and enhances the relaxation elicited by exogenous and neural-released nitric oxide in corpus cavernous. Sildenafil citrate increases uterine blood flow and potentiates estrogen-induced vasodilatation. Intravaginal administration of Sildenafil in the success of in vitro fertilization describes no deleterious effects on mother and fetus. The Natural Killer Cells activity and endometrial thickness were significantly changed after vaginal Sildenafil therapy so it might be an interesting therapeutic option before conception in women with recurrent reproductive failure.
Reduced flow / increased resistance in uterine and umbilical arteries, indicative of reduced uteroplacental flow in pregnancies with fetal growth restriction, has been documented by non-invasive Doppler ultrasound velocimetry.
- Conditions
- High Risk Pregnancy
- Being tested
- Sildenafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
oral sildenafil t.d.s for high-risk pregnancies
| Study group | Role | What they receive |
|---|---|---|
| sildenafile group A | received sildenafil citrate orally 20mg every 8 hours based on previous studies18,21 (Respatio tablet, pharma Egypt group) in addition to low molecular weight heparin daily according to the bodyweight at the booking visit (Clexane 20,40,60 mg, Sanofi eventis company) plus small dose of aspirin 75 mg (Aspocid 75mg tablet, CID pharmaceutical) once daily Receives: Drug: Sildenafil | |
| control group B | received low molecular weight heparin as subcutaneous injection once daily plus low dose aspirin 75mg orally once daily in addition to placebo three times daily prepared by a local pharmacy from a domestic manufacturer |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in abdominal circumference and estimated fetal weight after 2 weeks of therapy
ultrasound assessment of fetal growth
Measured: two weeks
Secondary outcomes (1)
amniotic fluid index 5-15 cm with minimum increase of 2 cm
ultrasound assessment of amniotic fluid
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study startJan 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar MY Elbaradie, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110444
- Sponsor's protocol ID
- SMElbaradie
- Status last verified
- Mar 2022
- First submitted
- 26 Sep 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil Citrate Added to Low Molecular Weight Heparin and Low Dose Aspirin to Improve Uteroplacental Perfusion in High-risk Pregnancy
- ClinicalTrials.gov ID
- NCT04110444
- Acronym / sponsor ID
- SMElbaradie
- Conditions
- High Risk Pregnancy
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anticoagulant therapy is indicated during pregnancy for the prevention and treatment of venous thromboembolism, systemic embolism in patients with mechanical heart valves and, in combination with aspirin, for the prevention of recurrent pregnancy loss in women with antiphospholipid antibodies Sildenafil citrate increases uterine blood flow and potentiates estrogen-induced vasodilatation. Intravaginal administration of Sildenafil in the success of in vitro fertilization describes no deleterious effects on mother and fetus
Detailed description
Pregnancy is considered an acquired hypercoagulable state due to increased concentration of coagulation factors, decreased levels of anticoagulants and decreased fibrinolytic capacity. Adverse pregnancy outcomes affect up to 15% of gestations and are the major cause of maternal and fetal morbidity and mortality. A poor perinatal outcome is expected in pregnancies with high vascular resistance in uterine circulation, but the pregnancies in which the resistance values are normalized in the later trimesters have a significantly better outcome.
For the prevention of fetal growth restriction, a recent large-study level meta-analysis and individual patient data meta-analysis confirm that aspirin modestly reduces small-for-gestational-age pregnancy in women at high risk (relative risk, 0.90, 95% confidence interval, 0.81-1.00) and that a dose of ≥100 mg should be recommended and to start at or before 16 weeks of gestation. Moreover, in vitro and in vivo studies suggest that low-molecular-weight heparin may prevent fetal growth restriction; however, evidence from randomized control trials is inconsistent.
In a normal pregnancy, the trophoblast produces nitric oxide (NO) which plays an important role in vasodilatation in the fetoplacental circulation to improve oxygen and nutritional supply to the fetus (9,10). Nitric oxide relaxes arterial and venous smooth muscle potently and might inhibit platelet aggregation and adhesion. Moreover, increased circulating phosphodiesterase (PDE) activity is suspected in women with preeclampsia. In pregnancies with fetal growth restriction and without preeclampsia, a reversible increased myometrial arterial tone by phosphodiesterase inhibition has been reported in vitro.
Phosphodiesterase type 5 inhibitors that potentiate nitric oxide availability such as sildenafil citrate have been extensively researched both in preclinical and clinical studies; Sildenafil citrate is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase (PDE)-5 leading to cyclic guanosine monophosphate (cGMP) accumulation and enhances the relaxation elicited by exogenous and neural-released nitric oxide in corpus cavernous. Sildenafil citrate increases uterine blood flow and potentiates estrogen-induced vasodilatation. Intravaginal administration of Sildenafil in the success of in vitro fertilization describes no deleterious effects on mother and fetus. The Natural Killer Cells activity and endometrial thickness were significantly changed after vaginal Sildenafil therapy so it might be an interesting therapeutic option before conception in women with recurrent reproductive failure.
Reduced flow / increased resistance in uterine and umbilical arteries, indicative of reduced uteroplacental flow in pregnancies with fetal growth restriction, has been documented by non-invasive Doppler ultrasound velocimetry.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sildenafile group A | – | Drug: Sildenafilreceived sildenafil citrate orally 20mg every 8 hours based on previous studies18,21 (Respatio tablet, pharma Egypt group) in addition to low molecular weight heparin daily according to the bodyweight at the booking visit (Clexane 20,40,60 mg, Sanofi eventis company) plus small dose of aspirin 75 mg (Aspocid 75mg tablet, CID pharmaceutical) once daily |
| control group B | – | –received low molecular weight heparin as subcutaneous injection once daily plus low dose aspirin 75mg orally once daily in addition to placebo three times daily prepared by a local pharmacy from a domestic manufacturer |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- high-risk pregnant women of gestational age 28-37 weeks women with current preeclampsia, IUGR and oligohydramnios
Key inclusion criteria (4 listed)
- high-risk pregnant women (women with current preeclampsia, IUGR and oligohydramnios)
- gestational age 28-37 weeks
- no major medical illness contraindicating sildenafil use (cardiovascular disease, sickle cell anaemia, retinopathy, hearing loss, liver diseases)
- willingness to sign informed consent for study randomization
Key exclusion criteria (10 listed)
- gestational age less than 28 weeks
- refusal of Doppler studies or sildenafil use
- contraindication or allergy to sildenafil
- those who can't present for monitoring visits or follow medication instructions
- those with major medical illness including cardiovascular disease and diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafiloral sildenafil t.d.s for high-risk pregnancies | Drug | sildenafile group A |
Primary outcome
change in abdominal circumference and estimated fetal weight after 2 weeks of therapy
Time frame: two weeks
ultrasound assessment of fetal growth
1 secondary outcome
amniotic fluid index 5-15 cm with minimum increase of 2 cm
Time frame: two weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk Pregnancy, run by Fayoum University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in abdominal circumference and estimated fetal weight after 2 weeks of therapy (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.