Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy, Prolonged Pre Eclampsia Oligohydramnios |
Drug: Misoprostol Device: Foley |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL. |
- Cervical ripening [ Time Frame: 48 hous after start the method ] [ Designated as safety issue: Yes ]
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.
- Cesarean [ Time Frame: The action of methods were assessed for 48 hours after start. ] [ Designated as safety issue: Yes ]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 [ Time Frame: 48 hours after start method ] [ Designated as safety issue: Yes ]In cases on the cervical ripening had occurred but the spontaneous labor not start.
- need of neonatal intensive care [ Time Frame: 7 first days after birth ] [ Designated as safety issue: Yes ]The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions.
| Enrollment: | 180 |
| Study Start Date: | January 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Misoprostol
Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)
|
Drug: Misoprostol
Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
Other Name: Prostokos 25 micrograms
|
|
Active Comparator: Foley
Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.
|
Device: Foley
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.
|
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.
Eligibility| Ages Eligible for Study: | 19 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts 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.
Contacts and Locations| Brazil | |
| MHVNCachoeirinha | |
| São Paulo, Brazil, 02720-200 | |
| Principal Investigator: | Nelson Sass, pHD | Maternidade Escola de Vila Nova Cachoeirinha |
More Information
Publications:
| Responsible Party: | Nelson Sass, Maternidade Escola de Vila Nova Cachoeirinha |
| ClinicalTrials.gov Identifier: | NCT01140971 History of Changes |
| Other Study ID Numbers: | MHVNCachoeirinha |
| Study First Received: | June 8, 2010 |
| Last Updated: | June 9, 2010 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Municipal Hospital Vila Nova Cachoeirinha:
|
Balloon dilatation, misoprostol, cervical ripening, obstetric labor, labor induced. |
Additional relevant MeSH terms:
|
Eclampsia Pre-Eclampsia Pregnancy, Prolonged Oligohydramnios Hypertension, Pregnancy-Induced Pregnancy Complications Misoprostol Anti-Ulcer Agents |
Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Oxytocics Reproductive Control Agents Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 16, 2013