Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04325243
Other study ID # SC-IPFD
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date July 31, 2022

Study information

Verified date January 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 410
Est. completion date July 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sildenafil 50 mg
50 mg oral Sildenafil tablet
Placebo oral tablet
placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy

Locations

Country Name City State
Egypt Ahmed Abbas Assiut Cairo

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 hours
See also
  Status Clinical Trial Phase
Completed NCT02221440 - Maternal Oxygen Administration for Fetal Distress N/A
Completed NCT03095937 - Evaluation of Fetal Cardiac Function in Rheumatic Heart Disease (RHD) Patients
Completed NCT00185887 - Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation N/A
Completed NCT02862925 - Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings. N/A
Recruiting NCT06186973 - Fetal Assessment of the Myocardium and Evaluation of the Neonate
Recruiting NCT05681624 - Maternal Oxygen Supplementation for Intrauterine Resuscitation N/A
Completed NCT05946681 - Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
Completed NCT03536910 - Evaluation of Copeptin Levels in Elective Cesarean Section With Different Anesthetic Technique N/A
Completed NCT03156608 - Novii External Fetal Monitoring Device N/A
Recruiting NCT00246766 - Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy N/A
Recruiting NCT04043299 - Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes Phase 3
Not yet recruiting NCT03859037 - Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation N/A
Completed NCT03370822 - A Mixed Methods Study to Explore the Feasibility of a Novel Continuous Fetal Monitoring Device
Terminated NCT05147584 - Trans-abdominal Fetal Pulse Oximetry N/A
Not yet recruiting NCT05727241 - Three-dimensional Umbilical Cord Coiling Index
Terminated NCT04081584 - Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
Completed NCT03764696 - Maternal Oxygen Administration for Fetal Distress II N/A
Completed NCT01042262 - Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase N/A
Not yet recruiting NCT04548453 - Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions Early Phase 1
Completed NCT03159234 - Prediction of Fetal Lung Maturity N/A