Stillbirth Clinical Trial
— PRISMOfficial title:
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
Verified date | November 2023 |
Source | NICHD Global Network for Women's and Children's Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1017 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Zambia | University Teaching Hospital | Lusaka |
Lead Sponsor | Collaborator |
---|---|
NICHD Global Network for Women's and Children's Health | Global Network for Women's and Children's Health Research, RTI International, University of Alabama at Birmingham, University Teaching Hospital, Lusaka, Zambia |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect size estimate of the intervention on the incidence of the composite neonatal outcome. | The outcome will be measured by overall number of eligible consented participants and incidence of the composite neonatal outcome. | From delivery to 7 days post delivery |
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