- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01973036
FOLCROM Trial: Foley Catheter in Rupture of Membranes (FOLCROM)
Foley Catheter Versus Oxytocin for Labor Induction in Women With Term and Near Term Premature Rupture of Membranes: A Randomized Clinical Trial (FOLCROM Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85006
- Banner Good Samaritan Regional Medical Center
-
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Delaware
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Newark, Delaware, United States, 19718
- Christiana Care Health System CCHS
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- LeHigh Valley Hospital
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Wilkes-Barre, Pennsylvania, United States, 18711
- Geisinger Wyoming Valley
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Spontaneous rupture of membranes (ROM) ≥1 hour prior to starting induction; ROM defined as clinical history with the presence of 2 of the following 4: pooling, ferning, nitrazine, oligohydramnios. In the absence of clinical history, oligohydramnios AND pooling must be present for ROM to be diagnosed. Oligohydramnios is defined as a total amniotic fluid index of <5cm or a maximum vertical pocket <2cm.
- Unfavorable cervix, defined as sterile digital exam ≤ 2cm dilated / 80% effaced
- Gestational age ≥ 34 weeks by best obstetric estimate
- Clinical management decision is vaginal delivery
- Singleton gestation
- Cephalic presentation
- Willing to participate and able to understand and sign the informed consent document before randomization
- Women of reproductive age
Exclusion Criteria:
- Multiple gestations
- Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18
- Latex allergy
- Greater than 1 prior cesarean delivery
- Active labor - defined as contractions more frequent than every 5 minutes (or ≥ 12 contractions in 1 hour) associated with ≥ 1 cm cervical change. In the absence of ≥ 1 cm cervical change after 2 hours, patients with contractions can be included in the study.
- Suspicion of chorioamnionitis
- Any contraindications to vaginal delivery, including malpresentation, active herpes, complete placenta previa, greater than two prior cesarean deliveries, etc.
- HIV positive status or AIDS
- Intrauterine fetal demise
- Suspected placental abruption, significant hemorrhage
- Nonreassuring fetal heart rate (FHR) pattern
- Participation in a competing trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oxytocin
This arm will receive oxytocin at a rate of 2 milliunits/milliliter.
If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter.
This infusion may be continued until delivery.
|
Each arm will receive oxytocin at a rate of 2 milliunits/milliliter.
If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter.
This infusion may be continued until delivery.
Other Names:
|
Experimental: Foley Catheter and Oxytocin
A 30cc/16 French (16F) foley catheter will be inserted by the provider under direct visualization or by palpation, ensuring that the catheter is appropriately and adequately positioned.
Oxytocin will be administered concurrently at a rate of 2 milliunits/milliliter (as noted under oxytocin active comparator).
If the catheter remains in place after 12 hours, it will be deflated and removed and oxytocin infusion will continue.
|
Each arm will receive oxytocin at a rate of 2 milliunits/milliliter.
If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter.
This infusion may be continued until delivery.
Other Names:
The balloon will be inflated with 30 cc of sterile saline.
The catheter will be taped to the patient's leg so that traction is maintained.
The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction.
Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From Induction of Labor Until Delivery
Time Frame: Time from induction to delivery (average 14.2 hours)
|
Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries
|
Time from induction to delivery (average 14.2 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Chorioamnionitis
Time Frame: Duration of Labor (average 4.8 hours)
|
Number of participants with chorioamnionitis excluding all those who were hospitalized with preterm premature rupture of membranes (PPROM) prior to 34 0/7 weeks. Chorioamnionitis was defined as temperature 38°C (or 100.4°F) or greater with at least two of the following: purulent discharge, maternal tachycardia (heart rate 100 beats per minute or greater), fetal tachycardia (heart rate 160 beats per minute or greater), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15,000 cells/mL3). Without Restriction = Chorioamnionitis was defined as temperature 38°C or greater and one of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis. With Restriction = Chorioamnionitis was defined as temperature 38°C or greater and two of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis. |
Duration of Labor (average 4.8 hours)
|
Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin
Time Frame: Duration of Labor (average 4.8 hours)
|
Duration of Labor (average 4.8 hours)
|
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Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin
Time Frame: Duration of Labor (average 4.8 hours)
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Duration of Labor (average 4.8 hours)
|
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Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
Time Frame: Duration of Labor (average 4.8 hours)
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Duration of Labor (average 4.8 hours)
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Rate of Failed Induction of Labor as the Indication for Cesarean
Time Frame: Duration of Labor (average 4.8 hours)
|
This will be defined by a combination of provider documentation and cervical dilation of ≤4cm/90% effaced or ≤5cm/any effacement after a minimum of 12 hours of oxytocin in the setting of adequate contraction. One patient was missing information for failed induction. |
Duration of Labor (average 4.8 hours)
|
Rate of Endomyometritis
Time Frame: Duration of hospital stay (average 3.4 days)
|
Endomyometritis defined as: Temperature ≥100.4°F
+ one of the following: fundal tenderness, maternal tachycardia (Heart Rate ≥ 100 BPM), purulent cervical discharge and no other source of fever
|
Duration of hospital stay (average 3.4 days)
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Maternal Length of Stay, From Admission to Discharge (Days)
Time Frame: Duration of hospital stay (average 3.4 days)
|
Duration of hospital stay (average 3.4 days)
|
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Rate of Five Minute Apgar Score < 5
Time Frame: Duration of hospital stay (average 3.4 days)
|
Apgar is a test for assessing a newborn shortly after birth to determine if extra medical care or emergency care may be needed.
Usually administered at 1 and 5 minutes after birth, the test includes assessment of Appearance, Pulse, Grimace, Activity and Respiration.
Scores range from 0 - 10.
|
Duration of hospital stay (average 3.4 days)
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Arterial Cord Blood Gas (pH), When Obtained
Time Frame: Within 1 hour of delivery
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Within 1 hour of delivery
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Rate of Neonatal Sepsis
Time Frame: Duration of hospital stay (average 3.4 days)
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Neonatal sepsis [positive blood or cerebrospinal fluid (CSF) cultures]
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Duration of hospital stay (average 3.4 days)
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Neonatal Intensive Care Unit (NICU) Admission Rate
Time Frame: Duration of hospital stay (average 3.4 days)
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Duration of hospital stay (average 3.4 days)
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Neonatal Length of Stay
Time Frame: Duration of hospital stay (average 3.4 days)
|
Duration of hospital stay (average 3.4 days)
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Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis
Time Frame: Duration of hospital stay (average 3.4 days)
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Chorioamnionitis/funisitis as determined by the pathologist examining the placenta
|
Duration of hospital stay (average 3.4 days)
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Time From Induction to Delivery (Hours)
Time Frame: Time from induction to delivery (average 14.2 hours)
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Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks
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Time from induction to delivery (average 14.2 hours)
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Overall Cesarean Delivery
Time Frame: Duration of hospital stay (average 3.4 days)
|
Duration of hospital stay (average 3.4 days)
|
|
Rate of Chorioamnionitis
Time Frame: Duration of hospital stay (average 3.4 days)
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Chorioamnionitis defined as (Temperature greater than or equal to 100.4 degrees fahrenheit or 38 degrees celsius) with at least 2 of the following: uterine tenderness, maternal tachycardia (HR greater than or equal to 100 bpm), fetal tachycardia (HR greater than or equal to 160bpm), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15000 cells/cubic milliliter)
|
Duration of hospital stay (average 3.4 days)
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Maternal Length of Stay From Delivery to Discharge (Hours)
Time Frame: Duration of hospital stay (average 3.4 days)
|
Duration of hospital stay (average 3.4 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Awathif D Mackeen, MD, MPH, Geisinger Clinic
Publications and helpful links
General Publications
- ACOG 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.
- Gunn GC, Mishell DR Jr, Morton DG. Premature rupture of the fetal membranes. A review. Am J Obstet Gynecol. 1970 Feb 1;106(3):469-83. doi: 10.1016/0002-9378(70)90378-9. No abstract available.
- Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
- Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005 Sep;106(3):593-601. doi: 10.1097/01.AOG.0000172425.56840.57.
- LANIER LR Jr, SCARBROUGH RW Jr, FILLINGIM DW, BAKER RE Jr. INCIDENCE OF MATERNAL AND FETAL COMPLICATIONS ASSOCIATED WITH RUPTURE OF THE MEMBRANES BEFORE ONSET OF LABOR. Am J Obstet Gynecol. 1965 Oct 1;93:398-404. doi: 10.1016/0002-9378(65)90068-2. No abstract available.
- Wolff K, Swahn ML, Westgren M. Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report. Gynecol Obstet Invest. 1998;46(1):1-4. doi: 10.1159/000009986.
- 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.
- Fitzpatrick CB, Grotegut CA, Bishop TS, Canzoneri BJ, Heine RP, Swamy GK. Cervical ripening with foley balloon plus fixed versus incremental low-dose oxytocin: a randomized controlled trial. J Matern Fetal Neonatal Med. 2012 Jul;25(7):1006-10. doi: 10.3109/14767058.2011.607522. Epub 2011 Dec 14.
- Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.
- Oliveira MV, Oberst PV, Leite GK, Aguemi A, Kenj G, Leme VD, Sass N. [Cervical Foley catheter versus vaginal misoprostol for cervical ripening and induction of labor: a randomized clinical trial]. Rev Bras Ginecol Obstet. 2010 Jul;32(7):346-51. doi: 10.1590/s0100-72032010000700007. Portuguese.
- Sanchez-Ramos L, Chen AH, Kaunitz AM, Gaudier FL, Delke I. Labor induction with intravaginal misoprostol in term premature rupture of membranes: a randomized study. Obstet Gynecol. 1997 Jun;89(6):909-12. doi: 10.1016/s0029-7844(97)00113-0.
- Wing DA, Paul RH. Induction of labor with misoprostol for premature rupture of membranes beyond thirty-six weeks' gestation. Am J Obstet Gynecol. 1998 Jul;179(1):94-9. doi: 10.1016/s0002-9378(98)70256-x.
- Zeteroglu S, Engin-Ustun Y, Ustun Y, Guvercinci M, Sahin G, Kamaci M. A prospective randomized study comparing misoprostol and oxytocin for premature rupture of membranes at term. J Matern Fetal Neonatal Med. 2006 May;19(5):283-7. doi: 10.1080/14767050600589807.
- Tan PC, Daud SA, Omar SZ. Concurrent dinoprostone and oxytocin for labor induction in term premature rupture of membranes: a randomized controlled trial. Obstet Gynecol. 2009 May;113(5):1059-1065. doi: 10.1097/AOG.0b013e3181a1f605.
- Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374. Erratum In: Obstet Gynecol. 2018 Apr;131(4):745.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0379
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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