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This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin plus papaverine | Active Comparator | Intervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin. |
|
| oxytocin alone | Placebo Comparator | Control Group: Oxytocin plus 100 mL saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Papaverine | Drug | papaverine a smooth muscle relaxant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| time to active delivery | time from labor induction till dilatation of 6 cm | 24 HOURS AFTER DELIVERY |
| Measure | Description | Time Frame |
|---|---|---|
| vaginal deliveries in 24 hours | rate of vaginal deliveries in 24 hours | 24 HOURS AFTER DELIVERY |
| total length of labor | time for induction to delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| inshirah sgayer | Contact | 0508890662 | inshirah.sg.sh@gmail.com |
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| ID | Term |
|---|---|
| D010208 | Papaverine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D053610 | Opiate Alkaloids |
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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.
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double blinded study
| normal saline |
| Drug |
normal saline 0.9% 100 cc |
|
|
| 24 HOURS AFTER DELIVERY |
| cesarean delivery rate | rate of emergent cesarean delivery during labor | ho24 HOURS AFTER DELIVERY |
| length of second stage of labor | second stage of labor in hours | 24 hours after delivery |
| D007546 |
| Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |