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Trial · Interventional

CompletedNot applicableResults postedRegistry data

FOLCROM Trial: Foley Catheter in Rupture of Membranes

Short name FOLCROM

NCTNCT01973036 (opens ClinicalTrials.gov in a new tab)Other id2013-0379
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
201 participants (actual)
Sponsor
Geisinger Clinic · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2014
Primary completion
Jul 2016
Completion
Aug 2016
First posted
31 Oct 2013 (estimated)
Last update posted
24 Sept 2018
Conditions
Premature Rupture of Membranes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. N/A

    FOLCROM

    NCT01973036

    Mar 2014 to Aug 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Foley CatheterDevice
  • OxytocinDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time From Induction of Labor Until Delivery

    Time frame · Time from induction to delivery (average 14.2 hours)

    Registry description

    Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries

Secondary outcomes(17)

  1. Number of Participants With Chorioamnionitis

    Time frame · Duration of Labor (average 4.8 hours)

    Registry 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.

  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)

    Registry 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.

  6. Rate of Endomyometritis

    Time frame · Duration of hospital stay (average 3.4 days)

    Registry 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

  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)

    Registry 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.

  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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry 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)

  17. Maternal Length of Stay From Delivery to Discharge (Hours)

    Time frame · Duration of hospital stay (average 3.4 days)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Time from induction to delivery (average 14.2 hours)

Time From Induction of Labor Until Delivery

GroupValue (hours)Spread
Oxytocin14.47.9
Foley Catheter and Oxytocin13.96.9
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Duration of Labor (average 4.8 hours)

Number of Participants With Chorioamnionitis

GroupValue (Participants)
Oxytocin2
Foley Catheter and Oxytocin9
Secondary outcomeCount of participants· 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

GroupValue (Participants)
Oxytocin46
Foley Catheter and Oxytocin34
Secondary outcomeCount of participants· Duration of Labor (average 4.8 hours)

Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin

GroupValue (Participants)
Oxytocin80
Foley Catheter and Oxytocin61
Secondary outcomeMedian· Duration of Labor (average 4.8 hours)

Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries

GroupValue (Minutes)
Oxytocin130
Foley Catheter and Oxytocin188
Secondary outcomeCount of participants· Duration of Labor (average 4.8 hours)

Rate of Failed Induction of Labor as the Indication for Cesarean

GroupValue (Participants)
Oxytocin6
Foley Catheter and Oxytocin8
Secondary outcomeCount of participants· Duration of hospital stay (average 3.4 days)

Rate of Endomyometritis

GroupValue (Participants)
Oxytocin0
Foley Catheter and Oxytocin0
Secondary outcomeMedian· Duration of hospital stay (average 3.4 days)

Maternal Length of Stay, From Admission to Discharge (Days)

GroupValue (days)
Oxytocin3
Foley Catheter and Oxytocin3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinThis 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. 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.0 / 1080 / 1080 / 108
Foley Catheter and OxytocinA 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. Foley Catheter: 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. Oxytocin: Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuri0 / 930 / 930 / 93

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies13

Studies that cite this trial.

More studies

13 studies on this page

Indexing hint: Systematic review · 2023

Mechanical methods for induction of labour.

de Vaan et al. 2023The Cochrane database of systematic reviewscited by 38

PMID 36996264PMC10061553DOI 10.1002/14651858.cd001233.pub4PUB-36996264

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2018

Corrected

Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial.

Mackeen et al. 2018Obstetrics and gynecologycited by 30

PMID 29215519DOI 10.1097/aog.0000000000002374PUB-29215519

Full text at the publisher
Publisher pageRead the notice

Indexing hint: Randomized controlled trial · 2012

Cervical ripening with foley balloon plus fixed versus incremental low-dose oxytocin: a randomized controlled trial.

Fitzpatrick et al. 2012The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricianscited by 8

PMID 21793769DOI 10.3109/14767058.2011.607522PUB-21793769

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2010

[Cervical Foley catheter versus vaginal misoprostol for cervical ripening and induction of labor: a randomized clinical trial].

Oliveira et al. 2010Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetriciacited by 15

PMID 21152844DOI 10.1590/s0100-72032010000700007PUB-21152844

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2009

Concurrent dinoprostone and oxytocin for labor induction in term premature rupture of membranes: a randomized controlled trial.

Tan et al. 2009Obstetrics and gynecologycited by 14

PMID 19384121DOI 10.1097/aog.0b013e3181a1f605PUB-19384121

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2008

Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial.

Pettker et al. 2008Obstetrics and gynecologycited by 39

PMID 18515515DOI 10.1097/aog.0b013e31817615a0PUB-18515515

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2006

A prospective randomized study comparing misoprostol and oxytocin for premature rupture of membranes at term.

Zeteroğlu et al. 2006The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricianscited by 16

PMID 16753768DOI 10.1080/14767050600589807PUB-16753768

Full text at the publisher
Publisher page

Indexing hint: Meta-analysis (pooled) · 2005

Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis.

Lin et al. 2005Obstetrics and gynecologycited by 34

PMID 16135593DOI 10.1097/01.aog.0000172425.56840.57PUB-16135593

Full text at the publisher
Publisher page

Indexing hint: Systematic review · 2001

Mechanical methods for induction of labour.

Boulvain et al. 2001The Cochrane database of systematic reviewscited by 49

PMID 11687101DOI 10.1002/14651858.cd001233PUB-11687101

Rights unknown
Source link

PubMed tag: none · 1998

Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report.

Wolff et al. 1998Gynecologic and obstetric investigationcited by 13

PMID 9692332DOI 10.1159/000009986PUB-09692332

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 1998

Induction of labor with misoprostol for premature rupture of membranes beyond thirty-six weeks' gestation.

Wing et al. 1998American journal of obstetrics and gynecologycited by 44

PMID 9704771DOI 10.1016/s0002-9378(98)70256-xPUB-09704771

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 1997

Labor induction with intravaginal misoprostol in term premature rupture of membranes: a randomized study.

Sanchez-Ramos et al. 1997Obstetrics and gynecologycited by 42

PMID 9170463DOI 10.1016/s0029-7844(97)00113-0PUB-09170463

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 1996

Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group.

Hannah et al. 1996The New England journal of medicinecited by 256

PMID 8598837DOI 10.1056/nejm199604183341601PUB-08598837

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
Not stated
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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