Sildenafil Citrate and Intrapartum Fetal Distress

NCT04325243 | Completed Phase 4

• 1 other identifier: SC-IPFD
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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

Conditions

Fetal Distress

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

study group

EXPERIMENTAL

50 mg oral sildenafil citrate tablet

Drug: Sildenafil 50 mg

placebo group

PLACEBO COMPARATOR

placebo tablets of the same shape, color and size of sildenafil citrate tablets

Drug: Placebo oral tablet

Interventions

Sildenafil 50 mg DRUG

50 mg oral Sildenafil tablet

study group

Placebo oral tablet DRUG

placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy

placebo group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy.
• Pregnant ≥ 37 weeks gestation.
• Fetus with longitudinal lie and vertex presentation.
• Healthy fetus with EFW\>2500 gm

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Fetal Distress

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 27, 2020
• Study Start: September 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: July 31, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

EG (1)