Sildenafil citrate to improve maternal and neonatal outcomes in low-resource settings: a randomized feasibility trial

Phase 2

• Conditions: Neonatal Diseases; Pregnancy and Childbirth

• Registration Number: PACTR202303797356166
• Lead Sponsor: niversity of Alabama at Birmingman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

?Pregnant women presenting in early labor with a term pregnancy (=37 weeks gestation)
oEarly labor will be defined as cervical dilation less than or equal to 6 cm
oGestational age will be calculated from the most reliable variable using the following hierarchy of reliability: 1) gestational dating ultrasound completed at any time during the pregnancy (with preference to the earliest exam), 2) date of last menstrual period if menses are regular
?Planned vaginal delivery
?Maternal age 18-50 years or an emancipated minor according to local standards
?A single, live fetus in cephalic presentation confirmed prior to randomization

Exclusion Criteria

?Unknown gestational age
?Maternal history of caesarian delivery
?Maternal contraindication to sildenafil therapy such as hypersensitivity to nitrates or nitrites
?Recognized fetal anomaly
?Any maternal medical condition or status that precludes informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
As a feasbility trail this study has objectives rather than outcomes. 1) Define the rate of and indication for fetal heart rate monitoring <br>2) Define the rate of and indication for operative delivery <br>3) Define the rates of bag and mask ventilation, Apgar score less than 5 at 1 minute, neonatal encephalopathy and perinatal mortality<br>4) Assess feasibility of drug administration during early labor, patient acceptance of the intervention, and enrollment rates across sites <br>5) Estimate effect size of the intervention on the incidence of the composite neonatal outcome including perinatal mortality and/or bag and mask resuscitation at birth <br>

Secondary Outcome Measures

Name	Time	Method
As a feasbility trail this study has objectives rather than outcomes. 1) Define the rate of and indication for fetal heart rate monitoring <br>2) Define the rate of and indication for operative delivery <br>3) Define the rates of bag and mask ventilation, Apgar score less than 5 at 1 minute, neonatal encephalopathy and perinatal mortality<br>4) Assess feasibility of drug administration during early labor, patient acceptance of the intervention, and enrollment rates across sites <br>5) Estimate effect size of the intervention on the incidence of the composite neonatal outcome including perinatal mortality and/or bag and mask resuscitation at birth