Hyoscine ButylBromide for Intrapartum Analgesia

NCT02557087 | Unknown Phase 2 DMC

• 1 other identifier: IP-HBB
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Analgesia, Obstetrical

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hyoscine

EXPERIMENTAL

Intravenous administration of Hyoscine N-butylbromide diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.

Drug: Hyoscine

Pethidine

ACTIVE COMPARATOR

Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.

Drug: Pethidine

Interventions

Hyoscine DRUG

Hyoscine

Pethidine DRUG

Pethidine

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

MeSH Terms

Conditions

Agnosia

Interventions

Scopolamine; Meperidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: TA

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 23, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 23, 2015

Record last verified: 2015-09