Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522854
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings a Randomized Pilot Feasibility Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this feasibility pilot clinical trial is to determine if sildenafil citrate 50mg orally up to three times during labor can 1 reduce perinatal mortality andor bag and mask ventilation at birth in planned vaginal delivery and 2 reduce the incidence of operative delivery instrumental vaginal birth or emergency cesarean section for presumed or suspected fetal distress in up to four facilities of different levels of care in low-resource countries
The main questions it aims to answer are
Does sildenafil citrate decrease
1 the incidence of operative delivery instrumental vaginal birth or emergency cesarean section for presumed or suspected fetal distress
2 the incidence of bag and mask ventilation
3 the incidence of perinatal mortality
Researchers will compare sildenafil citrate to a placebo a look-alike substance that contains no drug to see if sildenafil works to prevent fetal distress necessitating operative delivery bag and mask resuscitation at birth and ultimately perinatal mortality
Participants will
1 Take Sildenafil 50 mg or placebo orally every eight hours during labor up to 3 doses
2 Have the mothers and babies medical charts reviewed for outcomes including fetal distress operative delivery maternal side effects neonatal bag mask ventilation Apgar Scores and seizures
3 Have a neonatal neurological assessment prior to discharge
4 Receive telephone call assessments for re-hospitalization or mortality 7 days post delivery
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
Does sildenafil citrate decrease
1 the incidence of operative delivery instrumental vaginal birth or emergency cesarean section for presumed or suspected fetal distress
2 the incidence of bag and mask ventilation
3 the incidence of perinatal mortality
Researchers will compare sildenafil citrate to a placebo a look-alike substance that contains no drug to see if sildenafil works to prevent fetal distress necessitating operative delivery bag and mask resuscitation at birth and ultimately perinatal mortality
Participants will
1 Take Sildenafil 50 mg or placebo orally every eight hours during labor up to 3 doses
2 Have the mothers and babies medical charts reviewed for outcomes including fetal distress operative delivery maternal side effects neonatal bag mask ventilation Apgar Scores and seizures
3 Have a neonatal neurological assessment prior to discharge
4 Receive telephone call assessments for re-hospitalization or mortality 7 days post delivery
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:
Pregnant women with planned vaginal deliveries will be screened for eligibility After informed consent obtained subjects will be randomly assigned using computer generated stratified randomization codes by the pharmacy to either the treatment arm Sildenafil citrate or the placebo concurrent control Clinicians researchers and primary caregivers will be masked Eligible women 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 A neurological examination Sarnat and Thompson will be completed on the infant within 24 hours after birth Neonatal oxygen saturation will be measured by pulse oximetry at 48 hours or discharge whichever comes first Outcomes will be collected following delivery discharge and 7-days post-partum 7-day follow-up for outcomes will be obtained via a telephone call
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None