FOLCROM Trial: Foley Catheter in Rupture of Membranes

NCT01973036 | Completed Results DMC

• 1 other identifier: 2013-0379
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 5

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.

Conditions

Premature Rupture of Membranes

Keywords

foley catheter; foley bulb; oxytocin

Outcome Measures

Primary Outcomes (1)

• 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

  Time from induction to delivery (average 14.2 hours)

Secondary Outcomes (17)

• Number of Participants With Chorioamnionitis

  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

  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

  Duration of Labor (average 4.8 hours)

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

  Duration of Labor (average 4.8 hours)

• Rate of Failed Induction of Labor as the Indication for Cesarean

  Duration of Labor (average 4.8 hours)

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

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

Foley Catheter and Oxytocin

EXPERIMENTAL

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; Drug: Oxytocin

Interventions

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.

Also known as: 30cc/16 French

Foley Catheter and Oxytocin

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.

Also known as: Pitocin

Foley Catheter and Oxytocin; Oxytocin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (5)

Banner Good Samaritan Regional Medical Center

Phoenix, Arizona, 85006, United States

Location

Christiana Care Health System CCHS

Newark, Delaware, 19718, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Related Publications (16)

• 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.

  PMID: 19623003 BACKGROUND

• 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.

  PMID: 4905833 BACKGROUND

• 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.

  PMID: 14337377 BACKGROUND

• 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.

  PMID: 16135593 BACKGROUND

• 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.

  PMID: 9692332 BACKGROUND

• 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.

  PMID: 11687101 RESULT

• 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.

  PMID: 8598837 RESULT

• 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.

  PMID: 21793769 RESULT

• 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.

  PMID: 18515515 RESULT

• 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.

  PMID: 21152844 RESULT

• 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.

  PMID: 9170463 RESULT

• 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.

  PMID: 9704771 RESULT

• 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.

  PMID: 16753768 RESULT

• 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.

  PMID: 19384121 RESULT

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

• 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.

  PMID: 29215519 DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. A. Dhanya Mackeen
• Organization: Geisinger

admackeen@geisinger.edu

570-714-1099

Study Officials

• Awathif D Mackeen, MD, MPH

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: October 31, 2013
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 24, 2018
• Results First Posted: September 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)