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The effect of sildenafil citrate on cesarean section during labor

The effect of sildenafil citrate on fetal distress during labor and cesarean section - a double-blind clinical trial with placebo

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100303003485N5
Enrollment
104
Registered
2022-07-20
Start date
2022-07-23
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

Fetal distress in pregnancy.

Interventions

Intervention 1: Intervention group: a group of 104 people who received a package containing three oral capsules of sildenafil 50 mg brand Marham Darou (SDF), prepared by the pharmacy, up to a maximum

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age between 18-40 years Single pregnancy Term pregnancy (37-41 weeks) Normal fetal structure and without any anomalies Cephalic presentation Estimated weight above 2500 grams Without CPD Candidate for normal vaginal delivery

Exclusion criteria

Exclusion criteria: Drug reaction to Sildenafil Fetal anomalies Metabolic disorder Cardiac disorders Renal disorders Visual disorders Liver anomalies Previous cesarean Preeclampsia HTN Alcohol Taking medications Nitrate a-blocker

Design outcomes

Primary

MeasureTime frame
Need for cesarean section. Timepoint: The first dose of sildenafil or placebo when the participant is in the active phase of labor. For delivery, she enters the labor department and is given. Sildenafil is given orally 50 mg every 8 hours for a maximum of 3 doses. Method of measurement: The patient's blood pressure is measured every 15-30 minutes. Fetal heart rate is monitored.

Secondary

MeasureTime frame
Type of delivery. Timepoint: Until every stage of childbirth. Method of measurement: Will be recorded in the checklist.;Cesarean section indication. Timepoint: Until every stage of childbirth. Method of measurement: Will be recorded in the checklist.;Labor duration. Timepoint: Until every stage of childbirth. Method of measurement: Will be recorded in the checklist.;Abnormal bleeding during and after delivery. Timepoint: Until after delivery. Method of measurement: Will be recorded in the checklist.;Meconium excretion. Timepoint: Until every stage of childbirth. Method of measurement: Will be recorded in the checklist.;Need for fetal blood sampling. Timepoint: Until every stage of childbirth. Method of measurement: Will be recorded in the checklist.;Fetal distress. Timepoint: Until every stage of childbirth. Method of measurement: Will be recorded in the checklist.;Birth weight. Timepoint: After delivery. Method of measurement: Will be recorded in the checklist.;Neonatal sex. Timepoint: After delivery. Method of measurement: Will be recorded in the checklist.;Apgar scores. Timepoint: After delivery. Method of measurement: Will be recorded in the checklist.;Umbilical artery pH. Timepoint: Until every stage of childbirth. Method of measurement: Will be recorded in the checklist.;Need for neonatal resuscitation. Timepoint: After delivery. Method of measurement: Will be recorded in the checklist.;Length of time in neonatal intensive care unit. Timepoint: After delivery. Method of measurement: Will be recorded in the checklist.;Seizures. Timepoint: After delivery. Method of measurement: Will be recorded in the checklist.;Neonatal encephalopathy. Timepoint: After delivery. Method of measurement: Will be recorded in the checklist.;Fetal and infant death. Timepoint: After delivery. Method of measurement: Will be recorded in the checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh mahmoudi eisa abadi

Rasht University of Medical Sciences

Azade264@gmail.com+98 13 3336 9224

Outcome results

None listed

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