in case of cervix rigidity determination in first stage of labour, pregnant women will be offered to participate and if they accept they´ll be randomised to test or control group. Placebo or treatment will be administrated in 10 min. and the first control for all of them will be 60minutes later. Rest of controls and cares will be as usual in labour process.
Conditions
Interventions
Trade Name: BUSCOPAN
Product Name: BUSCOPAN
Product Code: 0104-752
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: HYOSCINE BUTYLBROMIDE
CAS Number: 149-64-4
Other descriptiv
Sponsors
LAURA TARRATS VELASCO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Detection, by means of vaginal exploration, of cervical rigidity in first stage of labour -18-40 year-old-pregnants -cephalic position of fetus -Term pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 82 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Non-treated glaucoma. -Taquicardia, miastenia gravis, paralitic ilium, mecanical estenose of guts, megacolon, allergy or hipersensitivity to Buscopan. -Treatment with: triciclic antidepressives, antihistamine drugs, quinidina, amantadina, disopiramida, domapine antagonists, betaadrenergics and others sucha as digoxine due to possible drug interaction. -previous cervical surgery -Less than 30 min since last peridural anesthetics dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate effectivity of Buscopan intravenous administration as an easier of cervical conditions in first stage of labour in pregnant women assisted in Hospital Universitari Germans Trias i Pujol from Badalona in 2012-2013;Secondary Objective: -To know if there are any differences in : -first stage of labour duration. -Neonatal results. -cervical conditions -fetus heartbeat rate pre-post administration.;Primary end point(s): -Administration or not administratin of Buscopan 40mg intravenous in first stage of labour.;Timepoint(s) of evaluation of this end point: -when rigid cervix is determined | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): maternal age, race, dilatation number, pregnancy weeks, ovular membranes state, Hodge valoration, cervical conditions, use of occitocine, cervix estimulation, fetal heart rate, Apgar test evaluation, newborn weight.;Timepoint(s) of evaluation of this end point: -ovular membranes state,Hodege valoration and cervical conditions at every cervical valoration. -Cervix estimulation: once, just considering if cervix has been estimulated or not. -use of oxitocine: used in intravenous continuous perfusion. used or not used. -fetal heart rate: pre, meanwhile and post-administration of drug or placebo. -Newborn Apgar test: 1 minute, 5 minutes and 10 minutes post-birth -Newborn weight: once in delivery ward. | — |
Countries
Spain
Contacts
Public ContactLAURA TARRATS VELASCO
LAURA TARRATS VELASCO
Outcome results
None listed