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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03430362
Other study ID # 25
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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