Pregnancy ComplicationNCT02372487
Sildenafil Citrate Therapy for Oligohydramnios
A study testing sildenafil citrate and fluid therapy in people with Pregnancy Complication, run by Al Hayat National Hospital at 3 sites in 2 countries.
Trial summary
The aim of this randomized trial is to detect whether or not the use of Sildenafil citrate therapy will increase the amniotic fluid volume expressed in term of amniotic fluid index measured via ultrasound for fetuses of pregnancies complicated by oligohydramnios, and to compare the outcomes of Sildenafil-treated… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complication
- What is being tested?
- sildenafil citrate and fluid therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2015to Jun 2016
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women will be included if they are of:
- any age, any parity
- carrying a singleton pregnancy
- gestational age (GA) 30 weeks or more (based on the last menstrual period and confirmed by the results of ultrasound or determined through early pregnancy sonography)
- Amniotic fluid index ≤ 5
- no pregnancy complications such as preeclampsia, gestational hypertension, or diabetes
- no prior history of kidney, lung, and heart disease (the use of bolus-fluid therapy is contraindicated in these patients)
- intact fetal membranes.
Who cannot join
- Mothers treated with prostaglandin synthetase inhibitors
- well established labor
- evidence of fetal distress (non-reactive non stress test)
- fetal complications (intrauterine growth retardation or obvious fetal anomalies)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Saudi Arabia2 sites, 2 recruiting
- Recruiting
Alhayah national hospital
Abhā
mohamed maher, +966558198655
tarek sayyed
- Recruiting
Alhayah national hospital
Abhā
mohamed maher, +966558198655
mohamed maher
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University
Shebin Elkom
tarek elsayed, 00201222739097
mohamed maher
About this study
The aim of this randomized trial is to detect whether or not the use of Sildenafil citrate therapy will increase the amniotic fluid volume expressed in term of amniotic fluid index measured via ultrasound for fetuses of pregnancies complicated by oligohydramnios, and to compare the outcomes of Sildenafil-treated pregnancies with similar pregnancies that will remain Sildenafil-naïve.
Read the detailed description
Women who will be referred to the maternity ward of both hospitals for a checkup and have the inclusion criteria will be offered admission for at least 24 hours to have complete rest aiming to increase the placental blood circulation of the uterus, which by itself can improve the amniotic fluid level. Patients will be randomly allocated into two groups according to a trial sequence determined via a computer generated random table. The trial sequence is hidden into opaque sequenced envelopes as each envelope contains an assignment for a single patient. Patients in first group will receive 2 liters of isotonic saline through intravenous infusion over a period of 4 hours using a rate of 250 ml per hour in addition to sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily and the same fluid regimen will be used in control group but without sildenafil citrate treatment. During hospital course maternal monitoring will be done using maternal vital signs for early detection of any manifestations of fluid overload while fetal monitoring will be done using non-stress test and all patients less than 34 completed weeks will receive dexamethasone in a total dose of 24mg to enhance fetal lung maturity in case expedited delivery is needed. Fasting will also be recommended during fluid therapy in case any emergency interference is required then all patients will resume their usual daily diet and fluid intake. All patients will then undergo sonography after 24 hours for reassessment of amniotic fluid index and those who will show an improvement of at least 20% will be discharged home and for those who still show no results the same regimen will be repeated. Discharged patients in first group will be asked to continue sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily plus a daily oral fluid intake of 2 liters while those in the control group will be asked only to have 2 liters daily oral fluid. Outpatient monitoring in both groups will depend on twice weekly non-stress test and once weekly amniotic fluid index and biophysical profile. Readmission and inpatient therapy using same protocol in each group will be indicated at any time if amniotic fluid index reduced to ≤ 5 cm. All patients also will be instructed to undergo periods of bed rest and, also they will be educated to count fetal kicks and to report immediately to the hospital if being unsatisfactory.
Patients in both groups will be monitored till they will go into spontaneous labor or till delivery will be indicated. The primary outcome measure will be the values of amniotic fluid index before and after therapy in each group and between both groups. The secondary outcome measures will be mode of delivery, gestational age at birth, fetal birth weight, and fetal and neonatal outcomes (Apgar scores, umbilical artery acid-base analysis at birth, and the need for transfer to the neonatal intensive care unit) which will be analyzed for the study and control groups.
- Conditions
- Pregnancy Complication
- Being tested
- sildenafil citrate, fluid therapy
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafil citrateDrug
sildenafil citrate 25 mg every 8 hours
fluid therapyDietary supplement
2 liters of fluid per day
| Study group | Role | What they receive |
|---|---|---|
| fluid therapy and sildenafil citrate | Active comparator | Patients in first group will receive 2 liters of isotonic saline through intravenous infusion over a period of 4 hours using a rate of 250 ml per hour in addition to sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily during hospitalization. After discharge patients in first group will be asked to continue sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily plus a daily oral fluid intake of 2 liters Receives: Drug: sildenafil citrate; Dietary Supplement: fluid therapy |
| fluid therapy | Active comparator | Patients in second group will receive 2 liters of isotonic saline through intravenous infusion over a period of 4 hours using a rate of 250 ml per hour. After discharge patients wil be asked to have 2 liters daily oral fluid Receives: Dietary Supplement: fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the values of amniotic fluid index before and after therapy in each group and between both groups
Measured: 9 months
Secondary outcomes (5)
mode of delivery
Measured: 9 months
gestational age at birth
Measured: 9 months
fetal birth weight
Measured: 9 months
Apgar scores
Measured: 9 months
the need for transfer to the neonatal intensive care unit
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayat National Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372487
- Sponsor's protocol ID
- ob/gyn 3
- Status last verified
- Feb 2016
- First submitted
- 10 Feb 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maher MA, Sayyed TM, Elkhouly N. Sildenafil Citrate Therapy for Oligohydramnios: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):615-620. doi: 10.1097/AOG.0000000000001928.
PubMed 28277352
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil Citrate Therapy for Oligohydramnios
- ClinicalTrials.gov ID
- NCT02372487
- Acronym / sponsor ID
- ob/gyn 3
- Conditions
- Pregnancy Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Al Hayat National HospitalUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 26 Feb 2015 (estimated)
- 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.
The aim of this randomized trial is to detect whether or not the use of Sildenafil citrate therapy will increase the amniotic fluid volume expressed in term of amniotic fluid index measured via ultrasound for fetuses of pregnancies complicated by oligohydramnios, and to compare the outcomes of Sildenafil-treated pregnancies with similar pregnancies that will remain Sildenafil-naïve.
Detailed description
Women who will be referred to the maternity ward of both hospitals for a checkup and have the inclusion criteria will be offered admission for at least 24 hours to have complete rest aiming to increase the placental blood circulation of the uterus, which by itself can improve the amniotic fluid level. Patients will be randomly allocated into two groups according to a trial sequence determined via a computer generated random table. The trial sequence is hidden into opaque sequenced envelopes as each envelope contains an assignment for a single patient. Patients in first group will receive 2 liters of isotonic saline through intravenous infusion over a period of 4 hours using a rate of 250 ml per hour in addition to sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily and the same fluid regimen will be used in control group but without sildenafil citrate treatment. During hospital course maternal monitoring will be done using maternal vital signs for early detection of any manifestations of fluid overload while fetal monitoring will be done using non-stress test and all patients less than 34 completed weeks will receive dexamethasone in a total dose of 24mg to enhance fetal lung maturity in case expedited delivery is needed. Fasting will also be recommended during fluid therapy in case any emergency interference is required then all patients will resume their usual daily diet and fluid intake. All patients will then undergo sonography after 24 hours for reassessment of amniotic fluid index and those who will show an improvement of at least 20% will be discharged home and for those who still show no results the same regimen will be repeated. Discharged patients in first group will be asked to continue sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily plus a daily oral fluid intake of 2 liters while those in the control group will be asked only to have 2 liters daily oral fluid. Outpatient monitoring in both groups will depend on twice weekly non-stress test and once weekly amniotic fluid index and biophysical profile. Readmission and inpatient therapy using same protocol in each group will be indicated at any time if amniotic fluid index reduced to ≤ 5 cm. All patients also will be instructed to undergo periods of bed rest and, also they will be educated to count fetal kicks and to report immediately to the hospital if being unsatisfactory.
Patients in both groups will be monitored till they will go into spontaneous labor or till delivery will be indicated. The primary outcome measure will be the values of amniotic fluid index before and after therapy in each group and between both groups. The secondary outcome measures will be mode of delivery, gestational age at birth, fetal birth weight, and fetal and neonatal outcomes (Apgar scores, umbilical artery acid-base analysis at birth, and the need for transfer to the neonatal intensive care unit) which will be analyzed for the study and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluid therapy and sildenafil citrate | Active comparator | Drug: sildenafil citrate, Dietary Supplement: fluid therapyPatients in first group will receive 2 liters of isotonic saline through intravenous infusion over a period of 4 hours using a rate of 250 ml per hour in addition to sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily during hospitalization. After discharge patients in first group will be asked to continue sildenafil citrate therapy (Viagra®) as 25 mg 3 times daily plus a daily oral fluid intake of 2 liters |
| fluid therapy | Active comparator | Dietary Supplement: fluid therapyPatients in second group will receive 2 liters of isotonic saline through intravenous infusion over a period of 4 hours using a rate of 250 ml per hour. After discharge patients wil be asked to have 2 liters daily oral fluid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- any age, any parity
- carrying a singleton pregnancy
- gestational age (GA) 30 weeks or more (based on the last menstrual period and confirmed by the results of ultrasound or determined through early pregnancy sonography)
- Amniotic fluid index ≤ 5
- no pregnancy complications such as preeclampsia, gestational hypertension, or diabetes
Key exclusion criteria (4 listed)
- Mothers treated with prostaglandin synthetase inhibitors
- well established labor
- evidence of fetal distress (non-reactive non stress test)
- fetal complications (intrauterine growth retardation or obvious fetal anomalies)
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 |
|---|---|---|
| sildenafil citratesildenafil citrate 25 mg every 8 hours | Drug | fluid therapy and sildenafil citrate |
| fluid therapy2 liters of fluid per day | Dietary supplement | fluid therapy, fluid therapy and sildenafil citrate |
Primary outcome
the values of amniotic fluid index before and after therapy in each group and between both groups
Time frame: 9 months
5 secondary outcomes
mode of delivery
Time frame: 9 months
gestational age at birth
Time frame: 9 months
fetal birth weight
Time frame: 9 months
Apgar scores
Time frame: 9 months
the need for transfer to the neonatal intensive care unit
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Derived from this study: PubMed 28277352Maher MA, Sayyed TM, Elkhouly N. Sildenafil Citrate Therapy for Oligohydramnios: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):615-620. doi: 10.1097/AOG.0000000000001928.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sildenafil citrate and fluid therapy in people with Pregnancy Complication, run by Al Hayat National Hospital at 3 sites in 2 countries.
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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Saudi Arabia, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the values of amniotic fluid index before and after therapy in each group and between both groups (time frame: 9 months). 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 NCT02372487, which also lists 1 linked publication.
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 3 Feb 2016.