Sildenafil Citrate and Intrapartum Fetal Distress

Fetal Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325243
• Other study ID #: SC-IPFD
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Fetal Distress

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