Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

FOLCROM Trial: Foley Catheter in Rupture of Membranes (FOLCROM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01973036
Recruitment Status : Completed
First Posted : October 31, 2013
Results First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Geisinger Clinic

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.

Condition or disease Intervention/treatment Phase
Premature Rupture of Membranes Device: Foley Catheter Drug: Oxytocin Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Oxytocin

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.
Drug: Oxytocin
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 Name: Pitocin

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.
Device: Foley Catheter
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 Name: 30cc/16 French

Drug: Oxytocin
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 Name: Pitocin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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) ]
  3. 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) ]
  4. Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries [ Time Frame: Duration of Labor (average 4.8 hours) ]
  5. 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.


  6. 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

  7. Maternal Length of Stay, From Admission to Discharge (Days) [ Time Frame: Duration of hospital stay (average 3.4 days) ]
  8. 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.

  9. Arterial Cord Blood Gas (pH), When Obtained [ Time Frame: Within 1 hour of delivery ]
  10. Rate of Neonatal Sepsis [ Time Frame: Duration of hospital stay (average 3.4 days) ]
    Neonatal sepsis [positive blood or cerebrospinal fluid (CSF) cultures]

  11. Neonatal Intensive Care Unit (NICU) Admission Rate [ Time Frame: Duration of hospital stay (average 3.4 days) ]
  12. Neonatal Length of Stay [ Time Frame: Duration of hospital stay (average 3.4 days) ]
  13. Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis [ Time Frame: Duration of hospital stay (average 3.4 days) ]
    Chorioamnionitis/funisitis as determined by the pathologist examining the placenta

  14. Time From Induction to Delivery (Hours) [ Time Frame: Time from induction to delivery (average 14.2 hours) ]
    Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks

  15. Overall Cesarean Delivery [ Time Frame: Duration of hospital stay (average 3.4 days) ]
  16. Rate of Chorioamnionitis [ Time Frame: Duration of hospital stay (average 3.4 days) ]
    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)

  17. Maternal Length of Stay From Delivery to Discharge (Hours) [ Time Frame: Duration of hospital stay (average 3.4 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Unfavorable cervix, defined as sterile digital exam ≤ 2cm dilated / 80% effaced
  3. Gestational age ≥ 34 weeks by best obstetric estimate
  4. Clinical management decision is vaginal delivery
  5. Singleton gestation
  6. Cephalic presentation
  7. Willing to participate and able to understand and sign the informed consent document before randomization
  8. Women of reproductive age

Exclusion Criteria:

  1. Multiple gestations
  2. Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18
  3. Latex allergy
  4. Greater than 1 prior cesarean delivery
  5. 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.
  6. Suspicion of chorioamnionitis
  7. Any contraindications to vaginal delivery, including malpresentation, active herpes, complete placenta previa, greater than two prior cesarean deliveries, etc.
  8. HIV positive status or AIDS
  9. Intrauterine fetal demise
  10. Suspected placental abruption, significant hemorrhage
  11. Nonreassuring fetal heart rate (FHR) pattern
  12. Participation in a competing trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973036


Locations
Layout table for location information
United States, Arizona
Banner Good Samaritan Regional Medical Center
Phoenix, Arizona, United States, 85006
United States, Delaware
Christiana Care Health System CCHS
Newark, Delaware, United States, 19718
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
Sponsors and Collaborators
Geisinger Clinic
Investigators
Layout table for investigator information
Principal Investigator: Awathif D Mackeen, MD, MPH Geisinger Clinic

Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT01973036     History of Changes
Other Study ID Numbers: 2013-0379
First Posted: October 31, 2013    Key Record Dates
Results First Posted: September 24, 2018
Last Update Posted: September 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Geisinger Clinic:
foley catheter
foley bulb
oxytocin

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs