Birth Asphyxia, Fetal Distress, Perinatal Asphyxia, Stillbirth
Conditions
Keywords
Fetal Distress, Perinatal Asphyxia, Sildenafil Citrate, Fetal Heart Rate Monitoring, Zambia
Brief summary
The PRISM pilot feasibility study consists of two phases to determine: 1) to delivery practices, rates of primary and secondary outcomes, and feasibility of enrollment rates, and 2) to assess the feasibility and acceptability of the intervention and expected enrollment rates, and estimate the effect size of sildenafil citrate on maternal and neonatal outcomes in a low resource settings in preparation for the main RCT.
Detailed description
The primary objectives of the PRISM pilot study relate to feasibility of a large randomized controlled trial of intrapartum sildenafil citrate and will aid in design of a definitive trial among pregnant women to day 42 postpartum (pp) and their newborns to day 28 pp. The pilot will help prepare for the main trial by allowing the investigators to: * Determine the rate and indication for fetal heart rate monitoring practices; * Determine the rate and indications for operative delivery; * Inform the rates of relevant primary and secondary outcomes to possibly target in a large randomized controlled trial of intrapartum sildenafil citrate; * Assess the feasibility and acceptability of the intervention and expected enrollment rates; * Estimate the effect size of sildenafil citrate on maternal and neonatal outcomes in a low resource setting.
Interventions
None listed
Sponsors
Global Network for Women's and Children's Health Research
University of Alabama at Birmingham
University Teaching Hospital, Lusaka, Zambia
RTI International
NICHD Global Network for Women's and Children's Health
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Admission to facility with plan for spontaneous or induced vaginal delivery * Early stage of labor (≤ 6 cm cervical dilation per local standard) at ≥ 37 weeks gestation * Age ≥ 18 years of age * Presence of single live fetus confirmed via a fetal heart rate by Doptone in cephalic position * Provision of written informed consent \[Note: if written consent is obtained at an early time, verbal re-confirmation is required at time of enrollment\]
Exclusion criteria
* Non-emancipated minors (as per local regulations) * Plan for Cesarean delivery or history of cesarean section prior to enrollment\* * Unknown gestational age * Advanced stage of labor (\>6 cm or 10 cm cervical dilation per local standards) and pushing or too distressed to understand, confirm, or give informed consent regardless of cervical dilation * Not capable of giving consent due to other health problems such as obstetric emergencies (for example, antepartum hemorrhage) or mental disorder; * Any medical condition considered a contraindication, including contraindication to sildenafil therapy, per the judgement of site investigators * Any maternal medical condition or status that precludes informed consent * Recognized fetal anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect size estimate of the intervention on the incidence of the composite neonatal outcome. | From delivery to 7 days post delivery | The outcome will be measured by overall number of eligible consented participants and incidence of the composite neonatal outcome. |
Countries
Zambia
Outcome results
None listed