Hyoscine ButylBromide for Intrapartum Analgesia

Ain Shams Maternity Hospital

Status and phase: Unknown; Phase 2

Conditions: Analgesia, Obstetrical

Treatments: Drug: Pethidine; Drug: Hyoscine

Study type: Interventional

Funder types: Other

Identifiers

NCT02557087

IP-HBB

Details and patient eligibility

About

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

Enrollment: 104 estimated patients

Sex: Female

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Hyoscine

Experimental group

Description:

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.

Treatment:

Drug: Hyoscine

Pethidine

Active Comparator group

Description:

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.

Treatment:

Drug: Pethidine