Sildenafil Citrate and Intrapartum Fetal Distress

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04325243
• Collaborator: (none)
• Enrollment: 410
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.9
• Patients Per Site Per Month: 17.9

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Fetal Distress	Drug: Sildenafil 50 mg; Drug: Placebo oral tablet	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 410 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Efficacy of Sildenafil Citrate to Reduce the Rate of Cesarean Section for Intrapartum Fetal Distress During Induction of Labor
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Apr 30, 2022
• Actual Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group 50 mg oral sildenafil citrate tablet	Drug: Sildenafil 50 mg; 50 mg oral Sildenafil tablet
Placebo Comparator: placebo group placebo tablets of the same shape, color and size of sildenafil citrate tablets	Drug: Placebo oral tablet; placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy

Outcome Measures

Primary Outcome Measures

1. The rate of cesarean section for intrapartum fetal distress [24 hours]

   Fetus will be considered to be distressed if Ominous fetal heart rate changes led to cesarean section was present

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

5. Intact membranes.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abbas	Assiut	Cairo	Egypt	002

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04325243
• Other Study ID Numbers: SC-IPFD
• First Posted: Mar 27, 2020
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fetal Distress; Sildenafil Citrate

Study Results

No Results Posted as of Aug 25, 2022