Prolonged Labor
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGNormal Saline 0.9%
Group B, will receive 2 ml of normal saline single intravenous dose
7\. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Group A will receive injection Hyoscine butyl bromide 20 mg first dose at the time of amniotomy, and second dose 2 hours after. Group B, will receive normal saline same volume first dose at the time of amniotomy, and second dose 2 hours after
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the duration of active phase of first stage of labor | 8 hours after hyoscine adminstration | time elapsed between start of active phase till full cervical dilatation |
Countries
Egypt
Outcome results
None listed