Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377098
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-12
Brief Title:
Intrapartum Sildenafil in Laboring Mothers
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-Resource Settings a Randomized Pilot Feasibility Trial Pilot Randomized Intrapartum Sildenafil in Mothers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISM
Brief Summary:
The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally up to three times during labor can be appropriately administered with limited clinical side effects to laboring mothers to determine feasibility across a spectrum of available healthcare resources
The main questions it aims to answer are
What are the fetal heart rate monitoring practices in a low-resource setting
What are the indications for operative delivery in a low-resource
What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil
What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting
Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo a look-alike substance that contains no drug to see if procedures are feasible the drug is tolerated the target outcomes are achievable and effect size is as expected
Participants will
Take Sildenafil 50 mgplacebo every eight hours or a placebo every eight hours for up to 24 hours during labor
Have the mothers babies medical charts reviewed for outcomes including fetal distress operative delivery maternal side effects neonatal bag mask ventilation Apgar scores and seizures
Have a neonatal neurological assessment prior to discharge
Have phone call assessments for re-hospitalization or mortality 7 days post-delivery
Receive child development assessments at 1 year 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call
The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate compared to placebo will decrease fetal distress and perinatal asphyxia
The main questions it aims to answer are
What are the fetal heart rate monitoring practices in a low-resource setting
What are the indications for operative delivery in a low-resource
What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil
What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting
Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo a look-alike substance that contains no drug to see if procedures are feasible the drug is tolerated the target outcomes are achievable and effect size is as expected
Participants will
Take Sildenafil 50 mgplacebo every eight hours or a placebo every eight hours for up to 24 hours during labor
Have the mothers babies medical charts reviewed for outcomes including fetal distress operative delivery maternal side effects neonatal bag mask ventilation Apgar scores and seizures
Have a neonatal neurological assessment prior to discharge
Have phone call assessments for re-hospitalization or mortality 7 days post-delivery
Receive child development assessments at 1 year 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call
The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate compared to placebo will decrease fetal distress and perinatal asphyxia
Detailed Description:
After informed consent obtained mother will be randomized using computer-generated stratified randomization codes by the pharmacy Clinicians researcher and primary caregivers will be masked Subjects will be randomly assigned to either the treatment arm or the placebo concurrent control
Eligible women who consent for the study will be randomized to receive sildenafil 50 mg orally every 8 hours up to a total of 3 doses or to receive the placebo every 8 hours up to a total of 3 does during the course of labor Neither medication no placebo will be given following completion of labor All additional care of the mother and infant will be provided according to the local standard of care Outcomes will be collected following delivery discharge and 7-days post-partum 7-day follow-up for outcomes will be obtained per a telephone call One two and three year infant developmental and behavior outcome will be assessed using the Ages and Stages Questionnaire
Eligible women who consent for the study will be randomized to receive sildenafil 50 mg orally every 8 hours up to a total of 3 doses or to receive the placebo every 8 hours up to a total of 3 does during the course of labor Neither medication no placebo will be given following completion of labor All additional care of the mother and infant will be provided according to the local standard of care Outcomes will be collected following delivery discharge and 7-days post-partum 7-day follow-up for outcomes will be obtained per a telephone call One two and three year infant developmental and behavior outcome will be assessed using the Ages and Stages Questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB Dixon Endowed Ch3102800 | OTHER_GRANT | UAB Dixon Endowed Chair | None |