CompletedNCT01973036FOLCROMUpdated Sep 24, 2018Results posted

FOLCROM Trial: Foley Catheter in Rupture of Membranes

An interventional study of Foley Catheter and Oxytocin in Premature Rupture of Membranes, sponsored by Geisinger Clinic. Completed at 5 sites in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-24.

Sponsored by Geisinger Clinic · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 201
Allocation: Randomized
Sex: Female

Study 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.

Read the 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.

Conditions studied

Premature Rupture of Membranes

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Keywords

foley catheter
foley bulb
oxytocin

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 201 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Geisinger Clinic is the lead sponsor of 125 studies on the registry; 21 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 201 participants (actual)

Study arms

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
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 · Drug: Oxytocin

Interventions

DeviceFoley 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.
Also known as: 30cc/16 French
DrugOxytocin
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

What researchers measure

Primary outcomes

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

Secondary outcomes

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.
Time frame: 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
Time frame: 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
Time frame: Duration of Labor (average 4.8 hours)
Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
Time frame: Duration of Labor (average 4.8 hours)
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.
Time frame: Duration of Labor (average 4.8 hours)
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
Time frame: Duration of hospital stay (average 3.4 days)
Maternal Length of Stay, From Admission to Discharge (Days)
Time frame: Duration of hospital stay (average 3.4 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.
Time frame: Duration of hospital stay (average 3.4 days)
Arterial Cord Blood Gas (pH), When Obtained
Time frame: Within 1 hour of delivery
Rate of Neonatal Sepsis
Neonatal sepsis \[positive blood or cerebrospinal fluid (CSF) cultures\]
Time frame: Duration of hospital stay (average 3.4 days)
Neonatal Intensive Care Unit (NICU) Admission Rate
Time frame: Duration of hospital stay (average 3.4 days)
Neonatal Length of Stay
Time frame: Duration of hospital stay (average 3.4 days)
Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis
Chorioamnionitis/funisitis as determined by the pathologist examining the placenta
Time frame: Duration of hospital stay (average 3.4 days)
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
Time frame: Time from induction to delivery (average 14.2 hours)
Overall Cesarean Delivery
Time frame: Duration of hospital stay (average 3.4 days)
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)
Time frame: Duration of hospital stay (average 3.4 days)
Maternal Length of Stay From Delivery to Discharge (Hours)
Time frame: Duration of hospital stay (average 3.4 days)

Results

Posted Sep 24, 2018

Participant flow

Women presenting to labor \& delivery with ruptured membranes with an unfavorable cervix based on sterile digital exam at greater than or equal to 34 weeks were approached by a study team member for participation.

Participant flow — Overall Study
Milestone	Oxytocin	Foley Catheter and Oxytocin
Started	108	93
Received assigned intervention	113	88
Completed	108	93
Not completed	0	0

Outcome measures

PrimaryTime 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 frame:: Time from induction to delivery (average 14.2 hours)
Reported as:: Mean · hours

Time From Induction of Labor Until Delivery
hours	Oxytocin	Foley Catheter and Oxytocin
Time From Induction of Labor Until Delivery	14.4 ± 7.9	13.9 ± 6.9

SecondaryNumber 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.

Time frame:: Duration of Labor (average 4.8 hours)
Reported as:: Count of participants · Participants

Number of Participants With Chorioamnionitis
Participants	Oxytocin	Foley Catheter and Oxytocin
Without Restrictions	2	9
With Restrictions	0	7

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin
Participants	Oxytocin	Foley Catheter and Oxytocin
Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin	46	34

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin
Participants	Oxytocin	Foley Catheter and Oxytocin
Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin	80	61

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

Time frame:: Duration of Labor (average 4.8 hours)
Reported as:: Median · Minutes

Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries
Minutes	Oxytocin	Foley Catheter and Oxytocin
First Stage	130 (76.5 to 226)	188 (111 to 294)
Second Stage	39 (15 to 88)	23 (11 to 72)
Third Stage	5 (3 to 6)	5 (3 to 7)

SecondaryRate 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.

Time frame:: Duration of Labor (average 4.8 hours)
Reported as:: Count of participants · Participants

Rate of Failed Induction of Labor as the Indication for Cesarean
Participants	Oxytocin	Foley Catheter and Oxytocin
Rate of Failed Induction of Labor as the Indication for Cesarean	6	8

SecondaryRate 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

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Count of participants · Participants

Rate of Endomyometritis
Participants	Oxytocin	Foley Catheter and Oxytocin
Rate of Endomyometritis	0	0

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

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Median · days

Maternal Length of Stay, From Admission to Discharge (Days)
days	Oxytocin	Foley Catheter and Oxytocin
Maternal Length of Stay, From Admission to Discharge (Days)	3 (2 to 3)	3 (2 to 4)

SecondaryRate 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.

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Count of participants · Participants

Rate of Five Minute Apgar Score < 5
Participants	Oxytocin	Foley Catheter and Oxytocin
Rate of Five Minute Apgar Score < 5	1	1

SecondaryArterial Cord Blood Gas (pH), When Obtained

Time frame:: Within 1 hour of delivery
Reported as:: Mean · pH

Arterial Cord Blood Gas (pH), When Obtained
pH	Oxytocin	Foley Catheter and Oxytocin
Arterial Cord Blood Gas (pH), When Obtained	7.25 ± 0.07	7.26 ± 0.07

SecondaryRate of Neonatal Sepsis

Neonatal sepsis \[positive blood or cerebrospinal fluid (CSF) cultures\]

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Count of participants · Participants

Rate of Neonatal Sepsis
Participants	Oxytocin	Foley Catheter and Oxytocin
Rate of Neonatal Sepsis	0	0

SecondaryNeonatal Intensive Care Unit (NICU) Admission Rate

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Count of participants · Participants

Neonatal Intensive Care Unit (NICU) Admission Rate
Participants	Oxytocin	Foley Catheter and Oxytocin
Neonatal Intensive Care Unit (NICU) Admission Rate	20	21

SecondaryNeonatal Length of Stay

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Median · hours

Neonatal Length of Stay
hours	Oxytocin	Foley Catheter and Oxytocin
Neonatal Length of Stay	49.7 ± 16.9	52.4 ± 20.0

SecondaryNumber of Participants With Confirmed Histologic Chorioamnionitis/Funisitis

Chorioamnionitis/funisitis as determined by the pathologist examining the placenta

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Count of participants · Participants

Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis
Participants	Oxytocin	Foley Catheter and Oxytocin
Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis	9	10

SecondaryTime 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

Time frame:: Time from induction to delivery (average 14.2 hours)
Reported as:: Mean · hours

Time From Induction to Delivery (Hours)
hours	Oxytocin	Foley Catheter and Oxytocin
Time From Induction to Delivery (Hours)	14.23 ± 8.19	14.16 ± 6.97

SecondaryOverall Cesarean Delivery

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Count of participants · Participants

Overall Cesarean Delivery
Participants	Oxytocin	Foley Catheter and Oxytocin
Overall Cesarean Delivery	21	25

SecondaryRate 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)

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Count of participants · Participants

Rate of Chorioamnionitis
Participants	Oxytocin	Foley Catheter and Oxytocin
Rate of Chorioamnionitis	0	7

SecondaryMaternal Length of Stay From Delivery to Discharge (Hours)

Time frame:: Duration of hospital stay (average 3.4 days)
Reported as:: Median · hours

Maternal Length of Stay From Delivery to Discharge (Hours)
hours	Oxytocin	Foley Catheter and Oxytocin
Maternal Length of Stay From Delivery to Discharge (Hours)	48.1 (38.8 to 57.2)	47.8 (41.2 to 58.7)

Adverse events

Collected over Adverse events were monitored from the time of randomization to the time the baby is discharged.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Oxytocin	0/108 (0%)	0/108 (0%)	0/108 (0%)
Foley Catheter and Oxytocin	0/93 (0%)	0/93 (0%)	0/93 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Oxytocin	Foley Catheter and Oxytocin	Total
Median	27 (22.8 to 31.4)	27.5 (23.4 to 32.2)	27.25 (23.35 to 31.9)

Sex: Female, Male
Sex: Female, Male(Participants)	Oxytocin	Foley Catheter and Oxytocin	Total
Female	108	93	201
Male	0	0	0

Study locations

5 sites

Banner Good Samaritan Regional Medical Center
Phoenix, Arizona 85006, United States
Christiana Care Health System CCHS
Newark, Delaware 19718, United States
Lehigh Valley Hospital
Allentown, Pennsylvania 18103, United States
Geisinger Medical Center
Danville, Pennsylvania 17822, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania 18711, United States

References and documents

Publications

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. PubMed 19623003 ↗
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. PubMed 4905833 ↗
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. PubMed 14337377 ↗
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. PubMed 16135593 ↗
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. PubMed 9692332 ↗
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. PubMed 11687101 ↗
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. PubMed 8598837 ↗
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. PubMed 21793769 ↗
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. PubMed 18515515 ↗
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. PubMed 21152844 ↗
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. PubMed 9170463 ↗
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. PubMed 9704771 ↗
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. PubMed 16753768 ↗
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. PubMed 19384121 ↗
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. doi: 10.1097/AOG.0000000000002541. PubMed 29215519 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01973036
Lead sponsor: Geisinger Clinic
Responsible party: Sponsor
First posted: Oct 31, 2013
Start date: Mar 2014
Primary completion: Jul 2016
Completion: Aug 2016
Results posted: Sep 24, 2018
Last update: Sep 24, 2018

Study contacts

Awathif D Mackeen, MD, MPH

principal investigator · Geisinger Clinic

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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