Induction of Labor
Conditions
Keywords
Induction of labor, low dose misoprostol, Foley Catheter
Brief summary
Evaluation of efficacy of inducing labour using a Foley's catheter and low dose oral misoprostol sequentially, in comparison with low dose oral misoprostol alone.
Detailed description
a multicentre, open-label randomised controlled trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with Foley's catheter for 16 hour and sequentially 25 μg oral misoprostol once every 2 hour, 2 nd group- 25 μg oral misoprostol once every 2 hour. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, rate of hyperstimulation ,hemorrage,chorioamnionitis (for evaluating safety)
Interventions
COMBINATION_PRODUCTMisoprostol 200mcg Tab
ranscervical Foley catheter (silicone, size 20F with 30ml balloon)+Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses
Sponsors
Asfendiyarov Kazakh National Medical University
Kazakhstan's Medical University KSPH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* women with an unfavourable cervix who will scheduled for induction of labour
Exclusion criteria
* Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of induction | 24 hours. | Number of Participants with vaginal births |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety for baby | 5 minutes | Rate of cases Apgar score \<7 points |
| Safety for mother | 24 hour | incidence of hyperstimulation |
| rete of hemorrage | 24 hour | bleeding more than 500 ml during the vaginal delivery, more than 1000 ml after c-section |
| rate of chorioamnionitis chorioamnionitis | 24 hour | meconial amniotic fluid, tachycardia, leukocytosis |
Countries
Kazakhstan
Outcome results
None listed