None listed
Conditions
Brief summary
Objective: To evaluate the impact of intramuscular (IM) dexamethasone alone or in combination of hyoscine butylbromide (HBB) on the duration of induced labour in Primigravida. Study Design: A randomized Single-blind placebo controlled study. Setting: The Obstetrics and Gynecology casuality department of Kasr El Aini hospital (Cairo University). Methodology: 150 primigravidas with singleton living healthy fetus undergo induction of labour (IOL) will be enrolled in the study. They will be randomized into 3 groups: group A in which 50 women received IM dexamethasone (8mg) 6 hours before IOL then IM 2 ml saline with the beginning of active phase, group B in which 50 women received IM dexamethasone (8mg) 6 hours before IOL then IM HBB (40 mg) with the beginning of active phase & group C (control group) in which 50 women received two IM saline injections (2 mL) 6 hours before IOL & with the beginning of active phase. For all patients, full history will be taken followed by complete physical examination & obstetric ultrasound. IOL will be done by using the following protocol; 2.5 mIU/min of oxytocin intravenous drip (in 500 mL lactated Ringer’s solution), with the dose increased by 2.5 mIU/ml every 20min till labour Establishment. Only patients will be blinded to the contents of syringes. Amniotomy will be done at cervical dilatation equal to 6 cm if spontaneous rupture of membranes does not occur. Participants will be monitored in bed together with fetal wellbeing surveillance using continuous CTG monitoring. A partogram will be maintained throughout labour and vaginal examinations will be conducted & recorded every 2 hours. primary outcomes will include comparing the duration of the latent phase of labour & the duration of active phase of labour among the three groups.
Interventions
compare effect of dexamethasone alone or in combination with hyoscine butylbromide on the duration of labour. In group A, 50 women will receive intramuscular 2 ml dexamethasone (8mg) 6 hours before induction of labour then intramuscular 2 ml saline with the beginning of active phase. In group B,50 women will receive intramuscular 2 ml dexamethasone (8mg) 6 hours before induction of labour then intramuscular 2 ml hyoscine butylbromide (40 mg) with the beginning of active phase. induction of labou
compare effect of dexamethasone alone or in combination with hyoscine butylbromide on the duration of labour. In group A, 50 women will receive intramuscular 2 ml dexamethasone (8mg) 6 hours before induction of labour then intramuscular 2 ml saline with the beginning of active phase. In group B,50 women will receive intramuscular 2 ml dexamethasone (8mg) 6 hours before induction of labour then intramuscular 2 ml hyoscine butylbromide (40 mg) with the beginning of active phase. induction of labour will be done by using the following protocol; 2.5 mIU/min of oxytocin intravenous drip (in 500 mL lactated Ringer’s solution), with the dose increased by 2.5 mIU/ml every 20min till labour Establishment
Sponsors
moutaz mahmoud elsherbini
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
primigravidas with singleton living healthy fetus undergo induction of labour,gestational age 38 to 41+6 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan), vertex presentation of the fetus, favorable cervix (Bishop Score EQUAL TO 7) & intact membranes
Exclusion criteria
Women who had chronic or pregnancy induced diseases or any contraindication to vaginal delivery (e.g. malpresentation, contracted pelvis & placenta previa), the maternal use of drugs (apart from nutritional supplementation), abnormal vaginal bleeding upon pelvic examination, abnormal fetal growth (IUGR or macrosomia), non-reassuring initial fetal CTG, presence of regular uterine contractions (3/10 mins.), uterine scar or anomalies, oligohydramnios (AFI < 5th percentile) & epidural analgesia.
Outcome results
None listed