Oligohydramnios, Pre Eclampsia, Pregnancy, Prolonged
Conditions
Keywords
Balloon dilatation,, misoprostol,, cervical ripening,, obstetric labor,, labor induced.
Brief summary
PURPOSE: The purpose of this study is to determine the effectiveness of balloon dilatation (Foley) with vaginal misoprostol for cervical ripening and induction of labor. METHOD: a randomized clinical assay has been performed with 160 women with indication of induction of labor, randomly divided in two groups, 80 for Foley catheter and 80 for misoprostol.
Detailed description
The cesarean delivery rate has risen dramatically in almost all world. Brazil shows the highest rate in the world so we need urgently efforts to reduce this fact. Several studies have shown that maternal morbidity and mortality rates are higher in cesarean deliveries. On the other hand an abdominal delivery cost much more than a vaginal delivery. A clinical trial to assess the performance of two simple and sheep methods can provide evidence based on local experience. Our results alow us to recommend both methods for clinical practice with a good possibility to reduce cesarean rates and without adverse events.
Interventions
DRUGMisoprostol
Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
DEVICEFoley
After Foley introduction, every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications.
Sponsors
Municipal Hospital Vila Nova Cachoeirinha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Gestational age from 37 weeks, * feto unic, alive and cephalic, * Bishop index equal or lesser than four.
Exclusion criteria
* uterine scar, * premature rupture of the membranes, * fetal weight bigger than 4000 g, * previous placenta, * conditions that imposed the immediate ending of the gestation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical ripening | 48 hous after start the method | Foley Group: catheter stay no more that 48 hours. Every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications. Misoprostol group: was introduced 25 microgram every 6 hour (max 200microg)if cervical conditions were unchanged. In the case of cervical evolution or start of labour the method was considered success.The failure was adopted if after 48 there was no cervical modifications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean | The action of methods were assessed for 48 hours after start. | After 48 hours if there was no cervical ripening or espontaneous labor the case was classified as failure of method and a cesarean was performed |
| Need of oxytocin | 48 hours after start method | In cases on the cervical ripening had occurred but the spontaneous labor not start. |
| need of neonatal intensive care | 7 first days after birth | The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions. |
Countries
Brazil
Outcome results
None listed