Hyoscine ButylBromide for Intrapartum Analgesia

Analgesia, Obstetrical Clinical Trial

Official title:

Efficacy of Intravenous Hyoscine ButylBromide as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02557087
• Other study ID #: IP-HBB
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 21, 2015
• Last updated: September 21, 2015
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2015
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess whether hyoscine butylbromide is as effective as pethidine for analgesia during the first stage of labor.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Primiparity

• Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)

• Maternal age between 20-30 years

• Singleton term pregnancy (37-42 weeks of gestation)

• Vertex-presenting fetus

Exclusion Criteria:

• Clinical evidence of cephalopelvic disproportion.

• Scarred uterus; previous cesarean section, hysterotomy or myomectomy.

• Any medical disorders associated with pregnancy.

• Fetal distress

• Receiving any regional or parenteral analgesia before recruitment in the study

• Known hypersensitivity to the drug family

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia, Obstetrical

Intervention

Drug:
• Hyoscine

• Pethidine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale.	Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 [no pain] to 10 [worst possible pain].	4 hours	Yes