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Completed

NCT Number: NCT01973036

FOLCROM Trial: Foley Catheter in Rupture of Membranes

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.

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Key information

Conditions

Premature Rupture of Membranes Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Banner Good Samaritan Regional Medical Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

foley catheter

Device

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: 30cc/16 French

Oxytocin

Drug

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: Pitocin

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study 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)

Acronym: FOLCROM

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2013
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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