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

Phase 2

Not yet recruiting

Conditions: Neonatal Diseases
Pregnancy and Childbirth

Registration Number: PACTR202303797356166

Lead Sponsor: niversity of Alabama at Birmingman

Brief Summary: Not available

Detailed Description: Not available

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