Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547437
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Effectiveness of Papaverine as an Adjunct to Oxytocin for Labor Induction A Randomized Controlled 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:
This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone
Detailed Description:
Labor induction is a common obstetric procedure aimed at stimulating uterine contractions to initiate labor often due to medical or obstetric indications such as post-term pregnancy preeclampsia or fetal growth restriction The primary objective is to achieve vaginal delivery while minimizing risks to both mother and child Oxytocin a synthetic analog of the natural hormone is the most frequently used pharmacological agent for labor induction due to its effectiveness in promoting uterine contractions However its use is associated with complications including uterine hyperstimulation increased need for epidural analgesia and higher rates of operative deliveries
The potential of antispasmodics to aid in labor induction has been explored with some studies indicating that these agents can reduce the duration of labor and enhance cervical dilation The Cochrane review on antispasmodics for labor highlighted that these drugs such as hyoscine butylbromide and drotaverine could significantly reduce the duration of the first stage of labor and increase the rate of cervical dilation although the overall quality of evidence was low Despite these findings further high-quality studies are recommended to substantiate these benefits and ensure safety
Papaverine a well-known smooth muscle relaxant traditionally used for treating vascular spasms presents a promising adjunctive therapy for labor induction By relaxing the smooth muscles of the cervix and uterus papaverine may facilitate more efficient cervical ripening and enhance the effectiveness of oxytocin-induced contractions Preliminary studies with other antispasmodics such as butylscopolamine have shown reductions in labor duration and improvements in labor progression without significant adverse effects suggesting that papaverine might offer similar benefits
This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone The primary outcome will be the time to onset of active labor with secondary outcomes including total duration of labor rate of cesarean deliveries maternal satisfaction and adverse effects By investigating this novel combination the study seeks to provide new insights into optimizing labor induction protocols ultimately improving maternal and neonatal outcomes
Objective To evaluate if adding papaverine to oxytocin reduces the time to active labor compared to oxytocin alone
Design a randomized controlled study Participants Pregnant women at term requiring labor induction using oxytocin Intervention Group Combined use of papaverine 80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin and oxytocin
Control Group Oxytocin plus 100 mL saline
Primary outcome Time to onset of active labor Secondary outcomes Total duration of labor length of first stage of labor length of second stage of labor rate of cesarean deliveries rate of cervical dilation
The potential of antispasmodics to aid in labor induction has been explored with some studies indicating that these agents can reduce the duration of labor and enhance cervical dilation The Cochrane review on antispasmodics for labor highlighted that these drugs such as hyoscine butylbromide and drotaverine could significantly reduce the duration of the first stage of labor and increase the rate of cervical dilation although the overall quality of evidence was low Despite these findings further high-quality studies are recommended to substantiate these benefits and ensure safety
Papaverine a well-known smooth muscle relaxant traditionally used for treating vascular spasms presents a promising adjunctive therapy for labor induction By relaxing the smooth muscles of the cervix and uterus papaverine may facilitate more efficient cervical ripening and enhance the effectiveness of oxytocin-induced contractions Preliminary studies with other antispasmodics such as butylscopolamine have shown reductions in labor duration and improvements in labor progression without significant adverse effects suggesting that papaverine might offer similar benefits
This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone The primary outcome will be the time to onset of active labor with secondary outcomes including total duration of labor rate of cesarean deliveries maternal satisfaction and adverse effects By investigating this novel combination the study seeks to provide new insights into optimizing labor induction protocols ultimately improving maternal and neonatal outcomes
Objective To evaluate if adding papaverine to oxytocin reduces the time to active labor compared to oxytocin alone
Design a randomized controlled study Participants Pregnant women at term requiring labor induction using oxytocin Intervention Group Combined use of papaverine 80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin and oxytocin
Control Group Oxytocin plus 100 mL saline
Primary outcome Time to onset of active labor Secondary outcomes Total duration of labor length of first stage of labor length of second stage of labor rate of cesarean deliveries rate of cervical dilation
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