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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Active Comparator | Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours) |
|
| Foley | Active Comparator | Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hous after start the method |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The action of methods were assessed for 48 hours after start. |
| Need of oxytocin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Sass, pHD | Maternidade Escola de Vila Nova Cachoeirinha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHVNCachoeirinha | São Paulo | São Paulo | 02720-200 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11704164 | Background | Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4. | |
| 15919393 | Background | Afolabi BB, Oyeneyin OL, Ogedengbe OK. Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor. Int J Gynaecol Obstet. 2005 Jun;89(3):263-7. doi: 10.1016/j.ijgo.2005.02.010. Epub 2005 Apr 2. |
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| ID | Term |
|---|---|
| D011273 | Pregnancy, Prolonged |
| D011225 | Pre-Eclampsia |
| D016104 | Oligohydramnios |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D014546 | Urinary Catheterization |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Foley | Device | 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. |
|
In cases on the cervical ripening had occurred but the spontaneous labor not start.
| 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. | 7 first days after birth |
| 11687101 | Background | Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D003950 | Diagnostic Techniques, Urological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |