Effect of sildenafil versus placebo on prevention and incidence of fetal distress and reduction of emergency cesarean section risk

Effect of sildenafil versus placebo on prevention and incidence of fetal distress and reduction of emergency cesarean section risk: a double-blind randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N435

Enrollment

140

Registered

2022-07-22

Start date

2022-08-06

Completion date

Unknown

Last updated

2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency cesarean section risk. Newborn (suspected to be) affected by Cesarean delivery

Interventions

Intervention 1: Intervention group: Sildenafil tablet (manufactured by Farma Shimi Co.) 50 mg every 8 hours up to three tablets. Intervention 2: Control group: Placebo tablet (manufactured by Farma Sh

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 50 years Gestational age of 37 to 42 weeks Singleton pregnancy Fetus with cephalic presentation Candidate for normal delivery

Exclusion criteria

Exclusion criteria: Fetal anomaly Chronic diseases such as cardiovascular, renal, liver or hypertension

Design outcomes

Primary

Measure	Time frame
Need for emergency cesarean section. Timepoint: Within 24 hours after the intervention. Method of measurement: Based on clinical observation.	—

Secondary

Measure	Time frame
Fetal distress. Timepoint: Within two weeks after the intervention. Method of measurement: Based on clinical observation.;Neonatal or maternal mortality. Timepoint: Within two weeks after the intervention. Method of measurement: Based on clinical observation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mahdieh Sadat Mirahmadi Nayeri

Hamedan University of Medical Sciences

m.mahdie@putlook.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026