Clinical trial

Efficacy of Sildenafil Citrate to Reduce the Rate of Cesarean Section for Intrapartum Fetal Distress During Induction of Labor

Name
SC-IPFD
Description
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
Trial arms
Trial start
2020-09-01
Estimated PCD
2022-04-30
Trial end
2022-07-31
Status
Completed
Phase
Early phase I
Treatment
Sildenafil 50 mg
50 mg oral Sildenafil tablet
Arms:
study group
Placebo oral tablet
placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy
Arms:
placebo group
Size
410
Primary endpoint
The rate of cesarean section for intrapartum fetal distress
24 hours
Eligibility criteria
Inclusion Criteria: 1. Singleton pregnancy. 2. Pregnant ≥ 37 weeks gestation. 3. Fetus with longitudinal lie and vertex presentation. 4. Healthy fetus with EFW\>2500 gm Exclusion Criteria: 1. Patients with previous cesarean delivery or uterine surgery. 2. Antepartum hemorrhage. 3. Cephalopelvic disproportion. 4. Category II or III non-stress test. 5. Medical disease as hypertension, cardiac, renal and hepatic disorders 6. Intrauterine fetal death. 7. Fetal growth restriction. 8. Fetuses with major congenital malformations. 9. 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. 10. Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 410, 'type': 'ACTUAL'}}
Updated at
2023-01-31

1 organization

2 products

1 indication

Organization
Assiut University
Product
Sildenafil
Indication
fetal distress
Product
Placebo