Intra-Uterine Growth RetardationIUGRNCT03153215
Sildenafil in Sever Intrauterine Growth Retardation
A study testing treatment in people with Intra-Uterine Growth Retardation, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Intra-Uterine Growth Retardation
- What is being tested?
- treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 6 May 2017to 31 Dec 2017
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnancy complicated by severe IUGR [abdominal circumference (AC)< 5th percentile] the gestational age <25 weeks or an estimate of the fetal weight was <600 gm (excluding known fetal anomaly/syndrome and/or planned termination) ( von Dadelszen.et al;2011).
Who cannot join
- known aneuploid anomaly, syndrome congenital infection.
- If there is a plan to terminate the pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction
Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.
Read the detailed description
The aim of our study is to evaluate the effect of sildenafil citrate therapy on severe early and late onset intrauterine growth retardation.A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a prospective case control study .
Patients will randomly be allocated to two groups with 23 patients in each group.Sildenafil citrate therapy may increase the likelihood of increased growth velocity [measured by abdominal circumference (AC) (ultrasound)] for fetuses of pregnancies complicated by severe early-onset IUGR .Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP which results in increased levels of cGMP, leading to smooth muscle relaxation. Placental disease, consequent on deficient uteroplacental blood flow, includes FGR, pre-eclampsia, and placental abruption and has been implicated in more than 50% of iatrogenic premature births .For this reason, the problem of severe FGR forms a substantial portion of the population that tertiary care centres care.
- Conditions
- Intra-Uterine Growth Retardation
- Being tested
- treatment, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatmentOther
We will offer Sildenafil citrate (20 mg per os three times daily until delivery) as innovative therapy to 23 women with severe IUGR ('Sildenafil-treated') in addition to fish oil and zinc supplementation.
PlaceboOther
Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | women with severe IUGR Receives: Other: treatment |
| Control group | Active comparator | women with severe IUGR Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical artery Pulsatility index
Change in umbilical artery pulsatility index after medication
Measured: between 24 gestational weeks until 36 weeks
Middle cerebral artery Pulsatility index
Change in middle cerebral artery pulsatility index after medication
Measured: between 24 gestational weeks until 36 weeks
fetal abdominal circumference growth velocity
proportion of women in each group for whom fetal AC growth velocity will change post randomization.
Measured: between 24 gestational weeks until 36 weeks
Secondary outcomes (2)
Rate of drug side effects
Women in the Sildenafil-treated group will be also monitored for adverse side-effects, such as flushing, lightheadedness and visual disturbance
Measured: between 24 and 36 gestational weeks
Birth weight
weight of neonate at birth in grams
Measured: between 24 and 36 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start6 May 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intra-Uterine Growth RetardationStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a randomized placebo control controlled study . Patients will randomly be allocated to two groups with 23 patients in each group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
- Investigators
- Nesreen A Shehata, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153215
- Sponsor's protocol ID
- Beni-Suef 12
- Acronym
- IUGR
- Status last verified
- Jul 2018
- First submitted
- 5 May 2017
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ananth CV, Vintzileos AM. Maternal-fetal conditions necessitating a medical intervention resulting in preterm birth. Am J Obstet Gynecol. 2006 Dec;195(6):1557-63. doi: 10.1016/j.ajog.2006.05.021. Epub 2006 Oct 2.
PubMed 17014813Lausman A, Kingdom J; MATERNAL FETAL MEDICINE COMMITTEE. Intrauterine growth restriction: screening, diagnosis, and management. J Obstet Gynaecol Can. 2013 Aug;35(8):741-748. doi: 10.1016/S1701-2163(15)30865-3. English, French.
PubMed 24007710Lee MJ, Conner EL, Charafeddine L, Woods JR Jr, Del Priore G. A critical birth weight and other determinants of survival for infants with severe intrauterine growth restriction. Ann N Y Acad Sci. 2001 Sep;943:326-39. doi: 10.1111/j.1749-6632.2001.tb03813.x.
PubMed 11594552
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Addition of Sildenafil Citrate for Treatment of Severe Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT03153215
- Acronym / sponsor ID
- IUGR / Beni-Suef 12
- Conditions
- Intra-Uterine Growth Retardation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 6 May 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 15 May 2017 (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.
Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.
Detailed description
The aim of our study is to evaluate the effect of sildenafil citrate therapy on severe early and late onset intrauterine growth retardation.A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a prospective case control study .
Patients will randomly be allocated to two groups with 23 patients in each group.Sildenafil citrate therapy may increase the likelihood of increased growth velocity [measured by abdominal circumference (AC) (ultrasound)] for fetuses of pregnancies complicated by severe early-onset IUGR .Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP which results in increased levels of cGMP, leading to smooth muscle relaxation. Placental disease, consequent on deficient uteroplacental blood flow, includes FGR, pre-eclampsia, and placental abruption and has been implicated in more than 50% of iatrogenic premature births .For this reason, the problem of severe FGR forms a substantial portion of the population that tertiary care centres care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a randomized placebo control controlled study . Patients will randomly be allocated to two groups with 23 patients in each group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: treatmentwomen with severe IUGR |
| Control group | Active comparator | Other: Placebowomen with severe IUGR |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnancy complicated by severe IUGR [abdominal circumference (AC)< 5th percentile] the gestational age <25 weeks or an estimate of the fetal weight was <600 gm (excluding known fetal anomaly/syndrome and/or planned termination) ( von Dadelszen.et al;2011).
Key exclusion criteria (2 listed)
- known aneuploid anomaly, syndrome congenital infection.
- If there is a plan to terminate the pregnancy.
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 |
|---|---|---|
| treatmentWe will offer Sildenafil citrate (20 mg per os three times daily until delivery) as innovative therapy to 23 women with severe IUGR ('Sildenafil-treated') in addition to fish oil and zinc supplementation. | Other | Intervention group |
| PlaceboPlacebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation. | Other | Control group |
Primary outcome
Umbilical artery Pulsatility index
Time frame: between 24 gestational weeks until 36 weeks
Change in umbilical artery pulsatility index after medication
Middle cerebral artery Pulsatility index
Time frame: between 24 gestational weeks until 36 weeks
Change in middle cerebral artery pulsatility index after medication
fetal abdominal circumference growth velocity
Time frame: between 24 gestational weeks until 36 weeks
proportion of women in each group for whom fetal AC growth velocity will change post randomization.
2 secondary outcomes
Rate of drug side effects
Time frame: between 24 and 36 gestational weeks
Birth weight
Time frame: between 24 and 36 gestational weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Background: PubMed 17014813Ananth CV, Vintzileos AM. Maternal-fetal conditions necessitating a medical intervention resulting in preterm birth. Am J Obstet Gynecol. 2006 Dec;195(6):1557-63. doi: 10.1016/j.ajog.2006.05.021. Epub 2006 Oct 2.
- Background: PubMed 24007710Lausman A, Kingdom J; MATERNAL FETAL MEDICINE COMMITTEE. Intrauterine growth restriction: screening, diagnosis, and management. J Obstet Gynaecol Can. 2013 Aug;35(8):741-748. doi: 10.1016/S1701-2163(15)30865-3. English, French.
- Background: PubMed 11594552Lee MJ, Conner EL, Charafeddine L, Woods JR Jr, Del Priore G. A critical birth weight and other determinants of survival for infants with severe intrauterine growth restriction. Ann N Y Acad Sci. 2001 Sep;943:326-39. doi: 10.1111/j.1749-6632.2001.tb03813.x.
- Individual participant dataSharing planned: No
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.
Nesreen A Shehata, MD principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment in people with Intra-Uterine Growth Retardation, run by Beni-Suef University 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jul 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Umbilical artery Pulsatility index (time frame: between 24 gestational weeks until 36 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153215, which also lists 3 linked publications.
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 10 Jul 2018.