E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To study the effect of Butylscopolamide Bromide on duration of the active phase of first stage of labor in women who cross the alert-line for labor dystocia, according to the WHO partograph. |
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E.1.1.1 | Medical condition in easily understood language |
Slow progress in labor is a common condition in obstetrics, and one of the most common indications for operative deliveries. Oxytocin, with several known side effects, is the only treatment option. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the effect of Butylscopolamide Bromide on duration of the active phase of first stage of labor in first time mothers who cross the alert-line for labor dystocia, according to the WHO partograph. |
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E.2.2 | Secondary objectives of the trial |
Duration of labor from the time when the participant was given IMP to delivery
Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery
Mode of delivery: Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery
Amount of oxytocin given, measured
1. As total time with treatment
2. As International Units (IU). The midwife measures mL of oxytocin solution given during labor. IU are calculated based on standardized concentration of the infusion solution [10 IU oxytocin in 1000 mL NaCl solution].
Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of each dose of IMP
Apgar score at 1 minute, 5 minutes and 10 minutes after delivery
pH levels in umbilical vein and artery after delivery
Admission to the Neonatal Intensive Care Unit
Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All of the following conditions must apply to the prospective patient at screening prior to receiving study agent (e.g.):
• ≥18 years
• Primiparous women
• Spontaneous onset of labor
• Active phase of labor
• ≥37 weeks of gestation
• Vertex position
• Crossing the alert line, i.e.: cervical dilatation of less than one cm per hour in the active phase of first stage of labor (cervix dilation ≥3 - <10 cm)
• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
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E.4 | Principal exclusion criteria |
Patients will be excluded from the study if they meet any of the following criteria:
• Multiple gestation
• Elective cesarean section
• Women in labor already receiving oxytocin when crossing the alert line
• Fully dilated cervix when crossing the alert line
• Preeclampsia defined as blood pressure ≥140/90 and proteinuria (+1 or more on a urine dipstick on more than one occasion) with debut after 20 weeks of pregnancy
• Previous major uterine surgery
• Known intestinal stenosis, ileus or megacolon
• Persisting maternal tachycardia (heart rate >130 beats per minute)
• Known maternal myasthenia gravis
• Persisting fetal tachycardia (fetal heart rate baseline >170 beats per minute)
• Untreated glaucoma
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: Duration from when the participant was given IMP, to 10 cm dilatation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The time from IMP to 10 cm dilatation will be determined when the participant reaches 10 cm dilatation. |
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E.5.2 | Secondary end point(s) |
Duration of labor from the time when the participant was given IMP to delivery
Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery
Mode of delivery: Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery
Amount of oxytocin given, measured
1. As total time with treatment
2. As International Units (IU). The midwife measures mL of oxytocin solution given during labor. IU are calculated based on standardized concentration of the infusion solution [10 IU oxytocin in 1000 mL NaCl solution].
Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of each dose of IMP
Apgar score at 1 minute, 5 minutes and 10 minutes after delivery
pH levels in umbilical vein and artery after delivery
Admission to the Neonatal Intensive Care Unit
Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Duration of labor from IMP to delivery: at delivery
Duration of labor from the onset of active labor to delivery: at delivery
Mode of delivery: Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery: at delivery
Amount of oxytocin given: determined after labor
Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of each dose of IMP
Apgar score at 1 minute, 5 minutes and 10 minutes after delivery
pH levels in umbilical vein and artery after delivery
Admission to the Neonatal Intensive Care Unit: after the hospital stay
Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire: 1-2 months post partum
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |