Pregnancy, ProlongedNCT01140971
Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor
A study testing Misoprostol and Foley in people with Pregnancy, Prolonged and Pre Eclampsia, run by Municipal Hospital Vila Nova Cachoeirinha at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Pregnancy, Prolonged, Pre Eclampsia, Oligohydramnios
- What is being tested?
- Misoprostol and Foley
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age from 37 weeks,
- feto unic, alive and cephalic,
- Bishop index equal or lesser than four.
Who cannot join
- uterine scar,
- premature rupture of the membranes,
- fetal weight bigger than 4000 g,
- previous placenta,
- conditions that imposed the immediate ending of the gestation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL.
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.
Read the 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.
- Conditions
- Pregnancy, Prolonged, Pre Eclampsia, Oligohydramnios
- Being tested
- Misoprostol, Foley
- Keywords
- Balloon dilatation,, misoprostol,, cervical ripening,, obstetric labor,, labor induced.
- Medical subject headings
- Pregnancy, Prolonged, Pre-Eclampsia, Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Prostokos 25 micrograms
Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
FoleyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours) Receives: Drug: Misoprostol |
| Foley | Active comparator | Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours. Receives: Device: Foley |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hous after start the method
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: 7 first days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, ProlongedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Municipal Hospital Vila Nova Cachoeirinha
- Sponsor type
- University, hospital or other
- Investigators
- Nelson Sass, pHD, Principal investigator, Maternidade Escola de Vila Nova Cachoeirinha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140971
- Sponsor's protocol ID
- MHVNCachoeirinha
- Status last verified
- Sep 2009
- First submitted
- 8 Jun 2010
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11704164Afolabi 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.
PubMed 15919393Boulvain 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.
PubMed 11687101
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL.
- ClinicalTrials.gov ID
- NCT01140971
- Acronym / sponsor ID
- MHVNCachoeirinha
- Conditions
- Pregnancy, Prolonged, Pre Eclampsia, Oligohydramnios
- Keywords
- Balloon dilatation,, misoprostol,, cervical ripening,, obstetric labor,, labor induced.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Municipal Hospital Vila Nova CachoeirinhaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: MisoprostolUse 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours) |
| Foley | Active comparator | Device: FoleyFoley catheter number 14 or 16 was installed intracervical for no more than 48 hours. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gestational age from 37 weeks,
- feto unic, alive and cephalic,
- Bishop index equal or lesser than four.
Key exclusion criteria (5 listed)
- uterine scar,
- premature rupture of the membranes,
- fetal weight bigger than 4000 g,
- previous placenta,
- conditions that imposed the immediate ending of the gestation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: Prostokos 25 microgramsVaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more | Drug | Misoprostol |
| FoleyAfter 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. | Device | Foley |
Primary outcome
Cervical ripening
Time frame: 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.
3 secondary outcomes
Cesarean
Time frame: The action of methods were assessed for 48 hours after start.
Need of oxytocin
Time frame: 48 hours after start method
need of neonatal intensive care
Time frame: 7 first days after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2010.
- Background: PubMed 11704164Sciscione 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.
- Background: PubMed 15919393Afolabi 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.
- Background: PubMed 11687101Boulvain 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.
Related trials for Pregnancy, Prolonged
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruitingPhase 2
CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
Meconium Aspiration Syndrome
RecruitingPhase 2
Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?
Bladder (Urothelial, Transitional Cell) Cancer, Non Muscle Invasive Bladder Cancer
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
RecruitingObservational study
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Urothelial Carcinoma, Urothelial Carcinoma Recurrent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson Sass, pHD principal investigator
Maternidade Escola de Vila Nova Cachoeirinha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and Foley in people with Pregnancy, Prolonged and Pre Eclampsia, run by Municipal Hospital Vila Nova Cachoeirinha at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical ripening (time frame: 48 hous after start the method). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01140971, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2010.