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To study the effect of Butylscopolamine 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | 1mL 20 mg/mL butylscopolamine bromide i.v. |
|
| Placebo | Placebo Comparator | 1mL 9mg/mL NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butylscopolamine Bromide 20 MG/ML | Drug | 1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of labor from the time when the participant was given IMP to delivery | Time to event variable | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration from when the participant was given IMP, to 10 cm dilatation | Time to event variable | Up to 24 hours |
| Mean cervical dilatation rate, calculated as mean cervical dilatation from IMP is given to 10 cm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trond M Michelsen, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital Rikshospitalet | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38547322 | Derived | Gaudernack LC, Einarsen AES, Sorbye IK, Lukasse M, Gunnes N, Michelsen TM. The effect of intravenous hyoscine butylbromide on slow progress in labor (BUSCLAB): A double-blind randomized placebo-controlled trial. PLoS Med. 2024 Mar 28;21(3):e1004352. doi: 10.1371/journal.pmed.1004352. eCollection 2024 Mar. |
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| ID | Term |
|---|---|
| D002086 | Butylscopolammonium Bromide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
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| Sodium Chloride 9mg/mL | Drug | 1 mL Sodium Chloride 9 mg/mL i.v. Single dose. |
|
Continuous variable
| Up to 24 hours |
| Duration of labor from the onset of active labor (at least 3 cm dilatation) to delivery | Time to event variable | Up to 24 hours |
| Spontaneous vaginal delivery vs operative delivery (vacuum, forceps or cesarean delivery) | Categorical variable, fraction of all deliveries | At birth |
| Vaginal delivery vs cesarean delivery | Categorical variable, fraction of all deliveries | At birth |
| Spontaneous vaginal delivery, vacuum delivery, forceps delivery, or emergency cesarean delivery | Categorical variable, fraction of all deliveries | At birth |
| Amount of oxytocin given, measured 1. As total time with treatment | Continuous variable, minutes | Up to 24 hours |
| Amount of oxytocin given, measured 2. As International Units (IU) | Continuous variable | At birth |
| Pain scores using a Visual Analogue Scale at baseline and 30 minutes after administration of IMP | Continuous variable, scale 1 to 9, where 9 is most severe pain | up to 30 minutes |
| Postpartum hemorrhage (mL) | Continuous variable | 2 hours after birth |
| Urinary retention, defined as need for urinary catheter before the participants leave the delivery ward | Categorical variable, fraction of women with urinary retention | 24 hours after birth |
| Anal sphincter injury | Categorical variable, fraction of all deliveries and fraction of all vaginal deliveries | At birth |
| Apgar score at 5 minutes and 10 minutes after delivery | Ordinal variable, score 0 to 10 where 10 is highest score indicating most vital neonate | 5 and 10 minutes after birth |
| pH levels in umbilical vein and artery after delivery | Continuous variable | At birth |
| Admission to the Neonatal Intensive Care Unit | Categorical variable, fraction of deliveries | Within 2 hours after birth |
| Birth experience measured by the validated questionnaire Child Birth Experience Questionnaire | Continuous variable for each category | 4 weeks after birth |
| D014326 |
| Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |