The effect of hyoscine butylbromide for shortening active phase of the first stage of labor : Double blind placebo-controlled trial

Phase 1

• Conditions: Singleton pregnancy in first stage of nplabor that plan vaginal delivery; hyoscine butyl bromide; duration of labor; pregnancy

• Registration Number: TCTR20230411002
• Lead Sponsor: khonkaen hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-04-06
• Study Start: 2023-04-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Singleton pregnant women >18 years old
term pregnancy with a cephalic presentation and planned vaginal delivery

Exclusion Criteria

High risk pregnancy with contraindication to vaginal delivery e.g., placenta previa, Previous uterine surgery, Cephalopelvic disproportion
Pregnancy women who received Epidural anesthesia.
Pregnancy women with high risk for unstable fetal status e.g., Placental abruption, Meconium stained amniotic fluid, Fetal anomaly, Non reassuring fetal status
Pregnancy women with contraindications for hyoscine-N-Butylbromide
Pregnancy women who has infection, chronic disease or pregnancy- induced diseases e.g., Maternal fever (Body temperature more than 37.8 degree celcius), Thyroid disease, cardiovascular disease, Autoimmune disease, Gestational diabetes mellitus, Pregnancy induced hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration in active phase of. 1 stage of labor since intervention/control drug was injected until cervix dilated 10 cm duration time (minute)

Secondary Outcome Measures

Name	Time	Method
Duration in second stage of labor since cervical fully dilate to fetus was deliveried Duration time (minute),duration in third stage of labor since fetus was deliveried until placenta was deliveried dutation time(minute),maternal adverse event since drug was injected until post partum 24 hr have/no have,neonatal outcome at 1,5 min APGAR score ,neonatal birth weight within 30 min after delivery grams,admission rate to nicu since birth until 24 hr post partum have/no have