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

Prolonged Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430362
• Other study ID #: 25
• Status: Completed
• Phase: N/A
• Start date: March 2, 2018
• Est. completion date: February 16, 2020

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 16, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prolonged Labor

Intervention

Drug:
• Hyoscine N Butylbromide
7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose
• Normal Saline 0.9%
Group B, will receive 2 ml of normal saline single intravenous dose

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the duration of active phase of first stage of labor	time elapsed between start of active phase till full cervical dilatation	8 hours after hyoscine adminstration