Back to resultsFOLCROM Trial: Foley Catheter in Rupture of Membranes (FOLCROM)
Primary Purpose
Premature Rupture of Membranes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foley Catheter
Oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Premature Rupture of Membranes focused on measuring foley catheter, foley bulb, oxytocin
Eligibility Criteria
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
Sites / Locations
- Banner Good Samaritan Regional Medical Center
- Christiana Care Health System CCHS
- Lehigh Valley Hospital
- Geisinger Medical Center
- Geisinger Wyoming Valley
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Oxytocin
Foley Catheter and Oxytocin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time From Induction of Labor Until Delivery
Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries
Secondary Outcome Measures
Number of Participants With Chorioamnionitis
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.
Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin
Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin
Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
Rate of Failed Induction of Labor as the Indication for Cesarean
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.
Rate of Endomyometritis
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
Maternal Length of Stay, From Admission to Discharge (Days)
Rate of Five Minute Apgar Score < 5
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.
Arterial Cord Blood Gas (pH), When Obtained
Rate of Neonatal Sepsis
Neonatal sepsis [positive blood or cerebrospinal fluid (CSF) cultures]
Neonatal Intensive Care Unit (NICU) Admission Rate
Neonatal Length of Stay
Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis
Chorioamnionitis/funisitis as determined by the pathologist examining the placenta
Time From Induction to Delivery (Hours)
Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks
Overall Cesarean Delivery
Rate of Chorioamnionitis
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)
Maternal Length of Stay From Delivery to Discharge (Hours)
Full Information
NCT ID
NCT01973036
First Posted
September 17, 2013
Last Updated
September 20, 2018
Sponsor
Geisinger Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01973036
Brief Title
FOLCROM Trial: Foley Catheter in Rupture of Membranes
Acronym
FOLCROM
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.
Detailed Description
This is a prospective, randomized, multi-center clinical trial to test the hypothesis that in women with term and near term premature rupture of membranes (PROM), an intrauterine Foley catheter plus oxytocin infusion will decrease the mean time from induction to delivery by 2.5 hours as compared to oxytocin alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Rupture of Membranes
Keywords
foley catheter, foley bulb, oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Foley Catheter and Oxytocin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Foley Catheter
Other Intervention Name(s)
30cc/16 French
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time From Induction of Labor Until Delivery
Description
Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries
Time Frame
Time from induction to delivery (average 14.2 hours)
Secondary Outcome Measure Information:
Title
Number of Participants With Chorioamnionitis
Description
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.
Time Frame
Duration of Labor (average 4.8 hours)
Title
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)
Title
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)
Title
Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
Time Frame
Duration of Labor (average 4.8 hours)
Title
Rate of Failed Induction of Labor as the Indication for Cesarean
Description
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.
Time Frame
Duration of Labor (average 4.8 hours)
Title
Rate of Endomyometritis
Description
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
Time Frame
Duration of hospital stay (average 3.4 days)
Title
Maternal Length of Stay, From Admission to Discharge (Days)
Time Frame
Duration of hospital stay (average 3.4 days)
Title
Rate of Five Minute Apgar Score < 5
Description
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.
Time Frame
Duration of hospital stay (average 3.4 days)
Title
Arterial Cord Blood Gas (pH), When Obtained
Time Frame
Within 1 hour of delivery
Title
Rate of Neonatal Sepsis
Description
Neonatal sepsis [positive blood or cerebrospinal fluid (CSF) cultures]
Time Frame
Duration of hospital stay (average 3.4 days)
Title
Neonatal Intensive Care Unit (NICU) Admission Rate
Time Frame
Duration of hospital stay (average 3.4 days)
Title
Neonatal Length of Stay
Time Frame
Duration of hospital stay (average 3.4 days)
Title
Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis
Description
Chorioamnionitis/funisitis as determined by the pathologist examining the placenta
Time Frame
Duration of hospital stay (average 3.4 days)
Title
Time From Induction to Delivery (Hours)
Description
Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks
Time Frame
Time from induction to delivery (average 14.2 hours)
Title
Overall Cesarean Delivery
Time Frame
Duration of hospital stay (average 3.4 days)
Title
Rate of Chorioamnionitis
Description
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)
Time Frame
Duration of hospital stay (average 3.4 days)
Title
Maternal Length of Stay From Delivery to Discharge (Hours)
Time Frame
Duration of hospital stay (average 3.4 days)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Awathif D Mackeen, MD, MPH
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Good Samaritan Regional Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Christiana Care Health System CCHS
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Wyoming Valley
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19623003
Citation
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.
Results Reference
background
PubMed Identifier
4905833
Citation
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.
Results Reference
background
PubMed Identifier
14337377
Citation
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.
Results Reference
background
PubMed Identifier
16135593
Citation
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.
Results Reference
background
PubMed Identifier
9692332
Citation
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.
Results Reference
background
PubMed Identifier
11687101
Citation
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.
Results Reference
result
PubMed Identifier
8598837
Citation
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.
Results Reference
result
PubMed Identifier
21793769
Citation
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.
Results Reference
result
PubMed Identifier
18515515
Citation
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.
Results Reference
result
PubMed Identifier
21152844
Citation
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.
Results Reference
result
PubMed Identifier
9170463
Citation
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.
Results Reference
result
PubMed Identifier
9704771
Citation
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.
Results Reference
result
PubMed Identifier
16753768
Citation
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.
Results Reference
result
PubMed Identifier
19384121
Citation
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.
Results Reference
result
PubMed Identifier
29215519
Citation
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.
Results Reference
derived
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FOLCROM Trial: Foley Catheter in Rupture of Membranes
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