Failed LabourNCT01390233
Comparison of Pre-Induction Cervical Ripening
A study testing Prepidil Gel, Urinary Balloon Catheter and Combined Urinary Catheter & Prepidil Gel in people with Failed Labour, run by University of South Carolina at 1 site in United States.
Trial summary
This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel. The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Failed Labour
- What is being tested?
- Prepidil Gel, Urinary Balloon Catheter and Combined Urinary Catheter & Prepidil Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single, live fetus
- Cephalic (head-first) presentation
- Reassuring fetal health assessment
- Gestational age between 26 and 42 weeks
- Maternal age 18 and above
- Bishop score less than 5
Who cannot join
- Multiple Gestation (twins, triplets, quadruplets)
- Fetal demise
- Fetal malpresentation
- Estimated fetal weight less than 500 grams or more than 4000 grams
- Placenta previa
- Non-reassuring fetal health assessment
Show all 10Show fewer
- Maternal asthma
- Latex allergy
- Spontaneous labor
- Other contraindication to vaginal delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
Palmetto Health Richland Hospital
Columbia, South Carolina, 29203
About this study
Official title: Comparison of Pre-Induction Cervical Ripening Using Prepidil Gel Administered Through a Urinary Balloon Catheter.
This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising. This has led to a renewed effort to examine the effectiveness of the varied methods of induction.
The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial. Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The investigator will be given the next sequentially numbered study randomization envelope by the patient's nurse. The randomization assignment will be unblinded to the patient and her physicians. If the patient is not in active labor 6 hours after initiation of the intervention, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Read the detailed description
Title: Comparison of pre-induction cervical ripening using Prepidil gel administered through a urinary balloon catheter
Precis- This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.
Background
Induction of labor is a common intervention during pregnancy1. The frequency of hospital admissions for induction of labor is increasing in the United States. Indications for induction of labor include maternal disease, fetal complications and social/geographical issues. Obstetricians may also choose elective induction, to facilitate delivery at term for the physician or patient who does not have a medical indication for delivery.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising2. This has led to a renewed effort to examine the effectiveness of the varied methods of induction3-5.
The vaginal delivery rate for induction of labor can be predicted by assessing the patient's cervical examination prior to induction. The Bishop Score uses the cervical examination components to predict the vaginal delivery rate for a particular patient. A low or poor Bishop score predicts a low success rate for vaginal delivery.
There are 3 common methods used to induce labor. The first are physiological methods such as breaking the patient's water or causing contractions by nipple stimulation. Breaking the patient's water requires a high (favorable) Bishop Score and cannot be safely performed with a low (poor) Bishop score. This method has a higher success rate in patients who have had a prior vaginal delivery. Nipple stimulation has been associated with an increased risk of tachysystole (too frequent contractions) and non-reassuring fetal heart rate patterns. It is not considered an acceptable method of induction in the United States.
Physical methods include pre-induction cervical ripening with laminaria or urinary balloon catheter6. Both of these methods are designed to force the cervix to open mechanically. Laminaria are small sticks of dehydrated seaweed which are placed in the cervical canal. As the sticks hydrate, the cervical canal dilates. Balloon urinary catheters are inserted into the cervical canal. The balloon is inflated in the lower uterine segment. A weight is placed on the catheter to apply traction which forces the fluid-filled balloon to dilate the cervical canal. Urinary balloon catheters have been used alone7,8, with saline infusion9-11 or with prostaglandin infusion12-16.
Pharmacological methods include ergot alkaloids, prostaglandin E and F series and oxytocin. Ergot alkaloids cause forceful uterine contractions and have been used to treat postpartum hemorrhage. Ergot alkaloids may cause severe hypertension during induction of labor and are not used in the United States. Prostaglandin E and F series cause increased uterine muscle tone (tonic contractions). They are used for pre-induction cervical ripening. The different prostaglandins have varying complications which may include nausea, vomiting, diarrhea and fever. Use of misoprostol for pre-induction cervical ripening has been associated with an increased risk of uterine rupture both in normal patients and in patients who have had previous cesarean sections17. The method of drug delivery for prostaglandin medications has varied. It can be administered as an oral tablet, a vaginal suppository, a vaginal gel, or by infusion into the lower uterine segment via a urinary balloon catheter. It is unclear, based on evidence-based medicine, whether any particular method of delivery is superior to another. The Food and Drug Administration of the United States (FDA) has approved the use of Prepidil gel (prostaglandin E2) for pre-induction cervical ripening18,19. Prepidil gel is administered as a gel into the vaginal fornix using a syringe. Oxytocin is a pituitary hormone which can be used to augment spontaneous labor or to induce labor. It results in both increased uterine tone (tonic contractions) and increased contraction frequency (clonic contractions). It is considered the most physiologic method of pre-induction cervical ripening. Oxytocin is administered by intravenous infusion.
Methods of induction can be used individually or in combination. The most common combination method for induction of labor is the use of prostaglandin for pre-induction cervical ripening followed by oxytocin.
Objectives-
The current study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. The primary outcome to be studied is vaginal delivery rate for urinary balloon catheter alone, prostaglandin gel alone and a combination of urinary balloon catheter and prostaglandin gel. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity.
The null hypothesis is that there is no difference in the vaginal delivery rate between the three study protocols.
Study Design and Methods-
Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial.
Eligible patients will undergo an interview with the investigator. Enrollment pre-requisites and exclusions will be reviewed with the patient. The patient will also be provided with written information regarding the safety of prepidil as an pre-induction cervical ripening agent and the safety of urinary balloon catheters as a pre-induction cervical ripening agent. The investigator will review general information on the trial and an informed consent. Patients who decline enrollment in the trial will have the method of pre-induction cervical ripening chosen by their physician.
Inclusion Criteria:
- Single, live fetus
- Cephalic (head-first) presentation
- Reassuring fetal health assessment
- Gestational age between 26 and 42 weeks
- Maternal age 18 and above
- Bishop score less than 5
Exclusion Criteria:
- Multiple Gestation (twins, triplets, quadruplets)
- Fetal demise
- Fetal malpresentation
- Estimated fetal weight less than 500 grams or more than 4000 grams
- Placenta previa
- Non-reassuring fetal health assessment
- Maternal asthma
- Latex allergy
- Spontaneous labor
- Other contraindication to vaginal delivery
Patients who enroll in the study will be randomized into 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be made by choosing a sealed envelope from the locked nurse medication storage area (Pyxis) located on Labor and Delivery at Palmetto Health Richland. Randomization will be 1:1:1 with randomization envelopes prepared by statisticians at the University of South Carolina Arnold School of Public Health. The investigator will be given the next sequentially numbered study envelope by the patient's nurse. The randomization included will be unblinded to the patient and her physicians.
URINARY BALLLOON CATHETER ONLY ARM
The patient will be placed in the lithotomy position, either in the bed or in stirrups. A baseline digital exam of the cervix will be performed by the physician and a Bishop score recorded. A urinary balloon catheter will be placed through the cervix into the lower uterine segment, either digitally or with the aid of a speculum. Once the catheter is properly positioned, the bulb will be inflated with 40ml of normal saline. The urinary balloon catheter will then be secured to the patient's thigh using tape. The catheter will then be placed under traction by attaching it to a liter bag of saline.
The catheter will be deflated and removed after 6 hours, with the time of removal recorded in the medical record. If the catheter is spontaneously expelled from the uterus, the time of expulsion will be noted by the nurse. Six (6) hours after insertion of the catheter, the physician will perform a digital cervical exam and a Bishop score recorded.
If the patient is not in active labor at the time of catheter removal or expulsion, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Artificial rupture of membranes may also be carried out at the physician's discretion.
PREPIDIL ONLY ARM
The patient will be placed in the lithotomy position, either in the bed or in stirrups. A baseline digital exam of the cervix will be performed by the physician and a Bishop score recorded in the medical record.
Prepidil gel will be inserted into the vaginal fornix according to the manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of the gel. Six (6) hours after insertion of the gel, the physician will perform a digital cervical exam and a Bishop score recorded.
If the patient is not in active labor 6 hours after the administration of Prepidil gel, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Artificial rupture of membranes may also be carried out at the physician's discretion.
COMBINED URINARY BALLOON CATHETER AND PREPIDIL GEL ARM
The patient will be placed in the lithotomy position, either in the bed or in stirrups. A baseline digital exam of the cervix will be performed by the physician and a Bishop score recorded. A urinary balloon catheter will be placed through the cervix into the lower uterine segment, either digitally or with the aid of a speculum. Once the catheter is properly positioned, the bulb will be inflated with 40ml of normal saline. The urinary balloon catheter will then be secured to the patient's thigh using tape. The catheter will then be placed under traction by attaching it to a liter bag of saline.
Prepidil gel will be inserted through the urinary balloon catheter into the lower uterine segment, in a dose equivalent to the manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and prepidil gel (even if the catheter is spontaneously expelled prior to that time). Six (6) hours after insertion of the catheter and gel, the physician will perform a digital cervical exam and a Bishop score recorded.
The catheter will be deflated and removed after 6 hours, with the time of removal noted by the nurse. If the catheter is spontaneously expelled from the uterus, the time of expulsion will be noted by the nurse. If the patient is not in active labor 6 hours after insertion of prepidil gel, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Artificial rupture of membranes may also be carried out at the physician's discretion.
- Conditions
- Failed Labour
- Being tested
- Prepidil Gel, Urinary Balloon Catheter, Combined Urinary Catheter & Prepidil Gel
- Keywords
- Labor, obstetric, Labor, induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepidil GelDrug
Pre-induction cervical ripening using dinoprostone gel in the vagina.
Urinary Balloon CatheterDevice
Also called Foley Catheter
Pre-induction cervical ripening using a urinary balloon catheter device.
Combined Urinary Catheter & Prepidil GelOther
Also called Foley catheter, Prepidil Gel
Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.
| Study group | Role | What they receive |
|---|---|---|
| Urinary Balloon Catheter Only | Active comparator | A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Receives: Device: Urinary Balloon Catheter |
| Prepadil Only | Active comparator | Prepidil Only : Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Receives: Drug: Prepidil Gel |
| Combined Urinary Catheter & Prepidil Gel | Experimental | A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence. Receives: Other: Combined Urinary Catheter & Prepidil Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Delivery
The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.
Measured: Gestational age 26-42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2010
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Failed LabourStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul C Browne, MD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390233
- Sponsor's protocol ID
- 2010-60
- Status last verified
- May 2014
- First submitted
- 11 Feb 2011
- Last updated
- 30 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.
PubMed 20334736Greybush M, Singleton C, Atlas RO, Balducci J, Rust OA. Preinduction cervical ripening techniques compared. J Reprod Med. 2001 Jan;46(1):11-7.
PubMed 11209625Matonhodze BB, Hofmeyr GJ, Levin J. Labour induction at term--a randomised trial comparing Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone. S Afr Med J. 2003 May;93(5):375-9.
PubMed 12830603Kelly AJ, Malik S, Smith L, Kavanagh J, Thomas J. Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003101. doi: 10.1002/14651858.CD003101.pub2.
PubMed 19821301ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
PubMed 19623003Heinemann J, Gillen G, Sanchez-Ramos L, Kaunitz AM. Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol. 2008 Aug;199(2):177-87; discussion 187-8. doi: 10.1016/j.ajog.2008.05.005.
PubMed 18674661James C, Peedicayil A, Seshadri L. Use of the Foley catheter as a cervical ripening agent prior to induction of labor. Int J Gynaecol Obstet. 1994 Dec;47(3):229-32. doi: 10.1016/0020-7292(94)90566-5.
PubMed 7705527Cromi A, Ghezzi F, Tomera S, Uccella S, Lischetti B, Bolis PF. Cervical ripening with the Foley catheter. Int J Gynaecol Obstet. 2007 May;97(2):105-9. doi: 10.1016/j.ijgo.2006.10.014. Epub 2007 Feb 20.
PubMed 17316649Saunders JR. Foley-catheter induction of labour. Br Med J. 1972 Oct 28;4(5834):237. doi: 10.1136/bmj.4.5834.237-a. No abstract available.
PubMed 5082574Hemlin J, Moller B. Extraamniotic saline infusion is promising in preparing the cervix for induction of labor. Acta Obstet Gynecol Scand. 1998 Jan;77(1):45-9.
PubMed 9492717Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. doi: 10.1097/01.AOG.0000198629.44186.c8.
PubMed 16449106Wagman H, Usherwood M. Intrauterine death treated with intrauterine extra-amniotic prostaglandin E2. Br J Clin Pract. 1974 Sep;28(9):318.
PubMed 4464977Luengo J, Keirse MJ, Bennebroek Gravenhorst J. Extraamniotic prostaglandin F2 alpha for intrauterine death and fetal abnormality. Eur J Obstet Gynecol Reprod Biol. 1977;7(5):325-9. doi: 10.1016/0028-2243(77)90017-x.
PubMed 299460Fuchs AR, Goeschen K, Rasmussen AB, Rehnstrom JV. Cervical ripening and plasma prostaglandin levels. Comparison of endocervical and extra-amniotic PGE2. Prostaglandins. 1984 Aug;28(2):217-27. doi: 10.1016/0090-6980(84)90058-3.
PubMed 6594722Liu HS, Chang YK, Chu TY, Yu MH, Chen WH. Extra-amniotic balloon with PGE2 versus extra-ovular Foley catheter with PGF2alpha in mid-trimester pregnancy termination. Int J Gynaecol Obstet. 1998 Oct;63(1):51-4. doi: 10.1016/s0020-7292(98)00114-3.
PubMed 9849711
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre-Induction Cervical Ripening Using Prepidil Gel Administered Through a Urinary Balloon Catheter.
- ClinicalTrials.gov ID
- NCT01390233
- Acronym / sponsor ID
- 2010-60
- Conditions
- Failed Labour
- Keywords
- Labor, obstetric, Labor, induced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Posted 30 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising. This has led to a renewed effort to examine the effectiveness of the varied methods of induction.
The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial. Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The investigator will be given the next sequentially numbered study randomization envelope by the patient's nurse. The randomization assignment will be unblinded to the patient and her physicians. If the patient is not in active labor 6 hours after initiation of the intervention, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Detailed description
Title: Comparison of pre-induction cervical ripening using Prepidil gel administered through a urinary balloon catheter
Precis- This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.
Background
Induction of labor is a common intervention during pregnancy1. The frequency of hospital admissions for induction of labor is increasing in the United States. Indications for induction of labor include maternal disease, fetal complications and social/geographical issues. Obstetricians may also choose elective induction, to facilitate delivery at term for the physician or patient who does not have a medical indication for delivery.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising2. This has led to a renewed effort to examine the effectiveness of the varied methods of induction3-5.
The vaginal delivery rate for induction of labor can be predicted by assessing the patient's cervical examination prior to induction. The Bishop Score uses the cervical examination components to predict the vaginal delivery rate for a particular patient. A low or poor Bishop score predicts a low success rate for vaginal delivery.
There are 3 common methods used to induce labor. The first are physiological methods such as breaking the patient's water or causing contractions by nipple stimulation. Breaking the patient's water requires a high (favorable) Bishop Score and cannot be safely performed with a low (poor) Bishop score. This method has a higher success rate in patients who have had a prior vaginal delivery. Nipple stimulation has been associated with an increased risk of tachysystole (too frequent contractions) and non-reassuring fetal heart rate patterns. It is not considered an acceptable method of induction in the United States.
Physical methods include pre-induction cervical ripening with laminaria or urinary balloon catheter6. Both of these methods are designed to force the cervix to open mechanically. Laminaria are small sticks of dehydrated seaweed which are placed in the cervical canal. As the sticks hydrate, the cervical canal dilates. Balloon urinary catheters are inserted into the cervical canal. The balloon is inflated in the lower uterine segment. A weight is placed on the catheter to apply traction which forces the fluid-filled balloon to dilate the cervical canal. Urinary balloon catheters have been used alone7,8, with saline infusion9-11 or with prostaglandin infusion12-16.
Pharmacological methods include ergot alkaloids, prostaglandin E and F series and oxytocin. Ergot alkaloids cause forceful uterine contractions and have been used to treat postpartum hemorrhage. Ergot alkaloids may cause severe hypertension during induction of labor and are not used in the United States. Prostaglandin E and F series cause increased uterine muscle tone (tonic contractions). They are used for pre-induction cervical ripening. The different prostaglandins have varying complications which may include nausea, vomiting, diarrhea and fever. Use of misoprostol for pre-induction cervical ripening has been associated with an increased risk of uterine rupture both in normal patients and in patients who have had previous cesarean sections17. The method of drug delivery for prostaglandin medications has varied. It can be administered as an oral tablet, a vaginal suppository, a vaginal gel, or by infusion into the lower uterine segment via a urinary balloon catheter. It is unclear, based on evidence-based medicine, whether any particular method of delivery is superior to another. The Food and Drug Administration of the United States (FDA) has approved the use of Prepidil gel (prostaglandin E2) for pre-induction cervical ripening18,19. Prepidil gel is administered as a gel into the vaginal fornix using a syringe. Oxytocin is a pituitary hormone which can be used to augment spontaneous labor or to induce labor. It results in both increased uterine tone (tonic contractions) and increased contraction frequency (clonic contractions). It is considered the most physiologic method of pre-induction cervical ripening. Oxytocin is administered by intravenous infusion.
Methods of induction can be used individually or in combination. The most common combination method for induction of labor is the use of prostaglandin for pre-induction cervical ripening followed by oxytocin.
Objectives-
The current study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. The primary outcome to be studied is vaginal delivery rate for urinary balloon catheter alone, prostaglandin gel alone and a combination of urinary balloon catheter and prostaglandin gel. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity.
The null hypothesis is that there is no difference in the vaginal delivery rate between the three study protocols.
Study Design and Methods-
Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial.
Eligible patients will undergo an interview with the investigator. Enrollment pre-requisites and exclusions will be reviewed with the patient. The patient will also be provided with written information regarding the safety of prepidil as an pre-induction cervical ripening agent and the safety of urinary balloon catheters as a pre-induction cervical ripening agent. The investigator will review general information on the trial and an informed consent. Patients who decline enrollment in the trial will have the method of pre-induction cervical ripening chosen by their physician.
Inclusion Criteria:
- Single, live fetus
- Cephalic (head-first) presentation
- Reassuring fetal health assessment
- Gestational age between 26 and 42 weeks
- Maternal age 18 and above
- Bishop score less than 5
Exclusion Criteria:
- Multiple Gestation (twins, triplets, quadruplets)
- Fetal demise
- Fetal malpresentation
- Estimated fetal weight less than 500 grams or more than 4000 grams
- Placenta previa
- Non-reassuring fetal health assessment
- Maternal asthma
- Latex allergy
- Spontaneous labor
- Other contraindication to vaginal delivery
Patients who enroll in the study will be randomized into 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be made by choosing a sealed envelope from the locked nurse medication storage area (Pyxis) located on Labor and Delivery at Palmetto Health Richland. Randomization will be 1:1:1 with randomization envelopes prepared by statisticians at the University of South Carolina Arnold School of Public Health. The investigator will be given the next sequentially numbered study envelope by the patient's nurse. The randomization included will be unblinded to the patient and her physicians.
URINARY BALLLOON CATHETER ONLY ARM
The patient will be placed in the lithotomy position, either in the bed or in stirrups. A baseline digital exam of the cervix will be performed by the physician and a Bishop score recorded. A urinary balloon catheter will be placed through the cervix into the lower uterine segment, either digitally or with the aid of a speculum. Once the catheter is properly positioned, the bulb will be inflated with 40ml of normal saline. The urinary balloon catheter will then be secured to the patient's thigh using tape. The catheter will then be placed under traction by attaching it to a liter bag of saline.
The catheter will be deflated and removed after 6 hours, with the time of removal recorded in the medical record. If the catheter is spontaneously expelled from the uterus, the time of expulsion will be noted by the nurse. Six (6) hours after insertion of the catheter, the physician will perform a digital cervical exam and a Bishop score recorded.
If the patient is not in active labor at the time of catheter removal or expulsion, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Artificial rupture of membranes may also be carried out at the physician's discretion.
PREPIDIL ONLY ARM
The patient will be placed in the lithotomy position, either in the bed or in stirrups. A baseline digital exam of the cervix will be performed by the physician and a Bishop score recorded in the medical record.
Prepidil gel will be inserted into the vaginal fornix according to the manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of the gel. Six (6) hours after insertion of the gel, the physician will perform a digital cervical exam and a Bishop score recorded.
If the patient is not in active labor 6 hours after the administration of Prepidil gel, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Artificial rupture of membranes may also be carried out at the physician's discretion.
COMBINED URINARY BALLOON CATHETER AND PREPIDIL GEL ARM
The patient will be placed in the lithotomy position, either in the bed or in stirrups. A baseline digital exam of the cervix will be performed by the physician and a Bishop score recorded. A urinary balloon catheter will be placed through the cervix into the lower uterine segment, either digitally or with the aid of a speculum. Once the catheter is properly positioned, the bulb will be inflated with 40ml of normal saline. The urinary balloon catheter will then be secured to the patient's thigh using tape. The catheter will then be placed under traction by attaching it to a liter bag of saline.
Prepidil gel will be inserted through the urinary balloon catheter into the lower uterine segment, in a dose equivalent to the manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and prepidil gel (even if the catheter is spontaneously expelled prior to that time). Six (6) hours after insertion of the catheter and gel, the physician will perform a digital cervical exam and a Bishop score recorded.
The catheter will be deflated and removed after 6 hours, with the time of removal noted by the nurse. If the catheter is spontaneously expelled from the uterus, the time of expulsion will be noted by the nurse. If the patient is not in active labor 6 hours after insertion of prepidil gel, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. Artificial rupture of membranes may also be carried out at the physician's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Urinary Balloon Catheter Only | Active comparator | Device: Urinary Balloon CatheterA urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. |
| Prepadil Only | Active comparator | Drug: Prepidil GelPrepidil Only : Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician. |
| Combined Urinary Catheter & Prepidil Gel | Experimental | Other: Combined Urinary Catheter & Prepidil GelA urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Single, live fetus
- Cephalic (head-first) presentation
- Reassuring fetal health assessment
- Gestational age between 26 and 42 weeks
- Maternal age 18 and above
Key exclusion criteria (10 listed)
- Multiple Gestation (twins, triplets, quadruplets)
- Fetal demise
- Fetal malpresentation
- Estimated fetal weight less than 500 grams or more than 4000 grams
- Placenta previa
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 |
|---|---|---|
| Prepidil GelPre-induction cervical ripening using dinoprostone gel in the vagina. | Drug | Prepadil Only |
| Urinary Balloon CatheterAlso: Foley CatheterPre-induction cervical ripening using a urinary balloon catheter device. | Device | Urinary Balloon Catheter Only |
| Combined Urinary Catheter & Prepidil GelAlso: Foley catheter, Prepidil GelPre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment. | Other | Combined Urinary Catheter & Prepidil Gel |
Primary outcome
Vaginal Delivery
Time frame: Gestational age 26-42 weeks
The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20334736Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.
- Background: PubMed 11209625Greybush M, Singleton C, Atlas RO, Balducci J, Rust OA. Preinduction cervical ripening techniques compared. J Reprod Med. 2001 Jan;46(1):11-7.
- Background: PubMed 12830603Matonhodze BB, Hofmeyr GJ, Levin J. Labour induction at term--a randomised trial comparing Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone. S Afr Med J. 2003 May;93(5):375-9.
- Background: PubMed 19821301Kelly AJ, Malik S, Smith L, Kavanagh J, Thomas J. Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003101. doi: 10.1002/14651858.CD003101.pub2.
- Background: PubMed 19623003ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
- Background: PubMed 18674661Heinemann J, Gillen G, Sanchez-Ramos L, Kaunitz AM. Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol. 2008 Aug;199(2):177-87; discussion 187-8. doi: 10.1016/j.ajog.2008.05.005.
- Background: PubMed 7705527James C, Peedicayil A, Seshadri L. Use of the Foley catheter as a cervical ripening agent prior to induction of labor. Int J Gynaecol Obstet. 1994 Dec;47(3):229-32. doi: 10.1016/0020-7292(94)90566-5.
- Background: PubMed 17316649Cromi A, Ghezzi F, Tomera S, Uccella S, Lischetti B, Bolis PF. Cervical ripening with the Foley catheter. Int J Gynaecol Obstet. 2007 May;97(2):105-9. doi: 10.1016/j.ijgo.2006.10.014. Epub 2007 Feb 20.
- Background: PubMed 5082574Saunders JR. Foley-catheter induction of labour. Br Med J. 1972 Oct 28;4(5834):237. doi: 10.1136/bmj.4.5834.237-a. No abstract available.
- Background: PubMed 9492717Hemlin J, Moller B. Extraamniotic saline infusion is promising in preparing the cervix for induction of labor. Acta Obstet Gynecol Scand. 1998 Jan;77(1):45-9.
- Background: PubMed 16449106Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. doi: 10.1097/01.AOG.0000198629.44186.c8.
- Background: PubMed 4464977Wagman H, Usherwood M. Intrauterine death treated with intrauterine extra-amniotic prostaglandin E2. Br J Clin Pract. 1974 Sep;28(9):318.
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.
Paul C Browne, MD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepidil Gel, Urinary Balloon Catheter and Combined Urinary Catheter & Prepidil Gel in people with Failed Labour, run by University of South Carolina at 1 site in United States.
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 6 inclusion and 10 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 30 May 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 30 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Vaginal Delivery (time frame: Gestational age 26-42 weeks). 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 NCT01390233, which also lists 32 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 30 May 2014.