Fetal DistressPhase 4NCT04325243
Sildenafil Citrate and Intrapartum Fetal Distress
A Phase 4 study testing Sildenafil 50 mg in people with Fetal Distress, run by Assiut University at 1 site in Egypt.
Trial summary
Induction of labour (IOL) is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean section. The most common causes are failed induction and intrapartum fetal distress. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Distress
- What is being tested?
- Sildenafil 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 31 Jul 2022
- Phase
- Phase 4
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancy.
- Pregnant ≥ 37 weeks gestation.
- Fetus with longitudinal lie and vertex presentation.
- Healthy fetus with EFW>2500 gm
Who cannot join
- Patients with previous cesarean delivery or uterine surgery.
- Antepartum hemorrhage.
- Cephalopelvic disproportion.
- Category II or III non-stress test.
- Medical disease as hypertension, cardiac, renal and hepatic disorders
- Intrauterine fetal death.
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- Fetal growth restriction.
- Fetuses with major congenital malformations.
- Women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), nitrates, medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors.
- Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Sildenafil Citrate to Reduce the Rate of Cesarean Section for Intrapartum Fetal Distress During Induction of Labor
Induction of labour (IOL) is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean section. The most common causes are failed induction and intrapartum fetal distress. In spite of significant advances in methods of IOL and intrapartum fetal monitoring, no interventions are proven to reduce the development of intrapartum fetal distress
- Conditions
- Fetal Distress
- Being tested
- Sildenafil 50 mg, Placebo oral tablet
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 50 mgDrug
50 mg oral Sildenafil tablet
Placebo oral tabletDrug
placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 50 mg oral sildenafil citrate tablet Receives: Drug: Sildenafil 50 mg |
| placebo group | Placebo comparator | placebo tablets of the same shape, color and size of sildenafil citrate tablets Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of cesarean section for intrapartum fetal distress
Fetus will be considered to be distressed if Ominous fetal heart rate changes led to cesarean section was present
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Sep 2020
- Primary completion30 Apr 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325243
- Sponsor's protocol ID
- SC-IPFD
- Status last verified
- Jan 2023
- First submitted
- 26 Mar 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sildenafil Citrate to Reduce the Rate of Cesarean Section for Intrapartum Fetal Distress During Induction of Labor
- ClinicalTrials.gov ID
- NCT04325243
- Acronym / sponsor ID
- SC-IPFD
- Conditions
- Fetal Distress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 27 Mar 2020 (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.
Induction of labour (IOL) is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean section. The most common causes are failed induction and intrapartum fetal distress. In spite of significant advances in methods of IOL and intrapartum fetal monitoring, no interventions are proven to reduce the development of intrapartum fetal distress
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Sildenafil 50 mg50 mg oral sildenafil citrate tablet |
| placebo group | Placebo comparator | Drug: Placebo oral tabletplacebo tablets of the same shape, color and size of sildenafil citrate tablets |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton pregnancy.
- Pregnant ≥ 37 weeks gestation.
- Fetus with longitudinal lie and vertex presentation.
- Healthy fetus with EFW>2500 gm
Key exclusion criteria (10 listed)
- Patients with previous cesarean delivery or uterine surgery.
- Antepartum hemorrhage.
- Cephalopelvic disproportion.
- Category II or III non-stress test.
- Medical disease as hypertension, cardiac, renal and hepatic disorders
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 50 mg50 mg oral Sildenafil tablet | Drug | study group |
| Placebo oral tabletplacebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy | Drug | placebo group |
Primary outcome
The rate of cesarean section for intrapartum fetal distress
Time frame: 24 hours
Fetus will be considered to be distressed if Ominous fetal heart rate changes led to cesarean section was present
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 31 Jan 2023.
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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?
A Phase 4 study testing Sildenafil 50 mg in people with Fetal Distress, run by Assiut 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 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: finished, as of the sponsor's last update on 31 Jan 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The rate of cesarean section for intrapartum fetal distress (time frame: 24 hours). 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 Jan 2023.