Effect Of Intravenous Hyoscine -N-Butyl Bromide In Management Of Prolonged Labor In Nulliparous

Cairo University (CU)

Status: Completed

Conditions: Prolonged Labor

Treatments: Drug: Hyoscine N Butylbromide; Drug: Normal Saline 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT03430362

25

Details and patient eligibility

About

Women will be admitted when active phase of labour starts defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation four centimeters with cervical effacement not less than 50% and no progress of labor for 2 hours or more.

Amniotomy was done in those with intact membrane and continuous electronic fetal monitoring was done. Women with prolonged labor after these measures were randomly divided using automated web-based randomization system into 2 equal groups. Group I included 50 women received 40mg HBB (Buscopan, Memphis Co, Giza, Egypt) intravenous bolus injection. Group II included 50 women received 2 ml of normal saline. The obstetrician, participants and outcome assessor were all blinded to the group assignment. Labor will be monitored by Vaginal examination every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labor until a fully dilated cervix was observed.

Full description

Women will be admitted when active phase of labour starts defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation four centimeters with cervical effacement not less than 50% and no progress of labor for 2 hours or more.

Amniotomy was done in those with intact membrane and continuous electronic fetal monitoring was done. Women with prolonged labor after these measures were randomly divided using automated web-based randomization system into 2 equal groups. Group I included 50 women received 40mg HBB (Buscopan, Memphis Co, Giza, Egypt) intravenous bolus injection. Group II included 50 women received 2 ml of normal saline. The obstetrician, participants and outcome assessor were all blinded to the group assignment. Labor will be monitored by Vaginal examination every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labor until a fully dilated cervix was observed.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Nulliparous women.

  • cervical dilatation in the active phase of less than 1.2 cm/h for nulliparous women
  • Gestational age ≥ 37 weeks.
  • Singleton pregnancy.
  • Vertex presentation.
  • Cervical dilatation ≥ 4cm.
  • No evidence of maternal or fetal distress.
  • Average size baby.

Exclusion criteria

• History of cervical surgery.
• Mal-presentation and mal-positions.
• Hypersensitivity to Hyoscine.
• Contraindication for vaginal delivery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Hyoscine group

Active Comparator group

Description:

7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose

Treatment:

Drug: Hyoscine N Butylbromide

Control group

Placebo Comparator group

Description:

Group B, will receive 2 ml of normal saline single intravenous dose

Treatment:

Drug: Normal Saline 0.9%