Neonatal Diseases Pregnancy and Childbirth
Conditions
Interventions
Sildenafil citrate
Control
Sponsors
University of Alabama at Birmingman
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: ? Pregnant women presenting in early labor with a term pregnancy (=37 weeks gestation) o Early labor will be defined as cervical dilation less than or equal to 6 cm o Gestational 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As a feasbility trail this study has objectives rather than outcomes. 1) Define the rate of and indication for fetal heart rate monitoring 2) Define the rate of and indication for operative delivery 3) Define the rates of bag and mask ventilation, Apgar score less than 5 at 1 minute, neonatal encephalopathy and perinatal mortality 4) Assess feasibility of drug administration during early labor, patient acceptance of the intervention, and enrollment rates across sites 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| As a feasbility trail this study has objectives rather than outcomes. 1) Define the rate of and indication for fetal heart rate monitoring 2) Define the rate of and indication for operative delivery 3) Define the rates of bag and mask ventilation, Apgar score less than 5 at 1 minute, neonatal encephalopathy and perinatal mortality 4) Assess feasibility of drug administration during early labor, patient acceptance of the intervention, and enrollment rates across sites 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 | — |
Countries
Kenya
Contacts
Public ContactNora Switchenko
Clinical assistant professor
Outcome results
None listed