Induction of Labor Affected Fetus / Newborn
Conditions
Brief summary
to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor
Detailed description
two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.
Interventions
DRUGMisoprostol
vaginal Misoprostol Plus Foley Catheter
DEVICEFoley Catheter
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Indication for labour induction Term pregnancy with alive fetus Bishop score less than five
Exclusion criteria
* Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| induction delivery interval (time from starting induction to delivery) | 48hours | safety issue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of doses needed to bring on labour | 48h | safety issue |
| Failed induction (failure to elicit contraction after 72 hours) | 72h | safety issue |
| Hyperstimulation syndrome | 24h | safety issue |
| Need of oxytocin for augmentation of labour | 48h | safety issue |
| Severe neonatal morbidity or perinatal death | 28 days | safety issue |
| Serious maternal morbidity or maternal death | 42 days | safety issue |
| Cesarean section | 72h | safety issue |
Countries
Egypt
Outcome results
None listed