An interventional study of Misoprostol and Foley in Pregnancy, Prolonged, Pre Eclampsia and Oligohydramnios, sponsored by Municipal Hospital Vila Nova Cachoeirinha. Completed at 1 site in Brazil. Open to female participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2010-06-10.
Sponsored by Municipal Hospital Vila Nova Cachoeirinha · Not applicable, Interventional, and Treatment
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.
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.
29 studies on the registry are indexed under Pregnancy, Prolonged; 2 are open to participants now.
This study's enrollment of 180 is above the median of 130 across 23 interventional studies indexed under Pregnancy, Prolonged.
Browse Pregnancy, Prolonged studies →This is the only study on the registry with Municipal Hospital Vila Nova Cachoeirinha as lead sponsor.
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Exclusion Criteria:
Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)
Drug: Misoprostol
Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.
Device: Foley
Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
Also known as: Prostokos 25 micrograms
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.
Cervical ripening
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.
Time frame: 48 hous after start the method
Cesarean
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
Time frame: The action of methods were assessed for 48 hours after start.
Need of oxytocin
In cases on the cervical ripening had occurred but the spontaneous labor not start.
Time frame: 48 hours after start method
need of neonatal intensive care
The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions.
Time frame: 7 first days after birth
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Misoprostol