Labor; Forced or Induced, Affecting Fetus or NewbornPhase 4NOFOXNCT02273115

Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor

A Phase 4 study testing Oxytocin and Transcervical Foley catheter in people with Labor; Forced or Induced, Affecting Fetus or Newborn, run by Christiana Care Health Services at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Labor; Forced or Induced, Affecting Fetus or Newborn
What is being tested?: Oxytocin and Transcervical Foley catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 323 participants
Where: 2 sitesUnited States
Study dates: Oct 2014to 11 Sep 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age greater than 18 years
Pregnant, singleton gestation, vertex presentation
Admitted for induction of labor between gestational ages 24 - 42 weeks
Bishop score <6

Who cannot join

Multiple gestation
Non-vertex presentation
Latex allergy or latex-free Foley catheter to be placed
Fetal death
Anomalous fetus
Placenta/vasa previa

Show all 15Show fewer

Placental abruption (known or suspected)
Intrapartum bleeding
Non-reassuring fetal tracing with following criteria: category III tracing, OR minimal variability AND decelerations of any kind, OR late decelerations occurring >50% of contractions
2 or more previous cesarean section, myomectomy, or classical cesarean
Need to use ripening agents prior to Foley placement
Spontaneous labor
Active genital herpes
Inability to consent
Any contraindication to a vaginal delivery

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Christiana Care Health Services
Newark, Delaware, 19713
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX): a Randomized Control Trial

The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity.

Read the detailed description

This is a multi-center, open-label, randomized study. Women with a singleton, vertex gestation between 24-42 weeks gestations presenting for labor induction will be offered participation in this study. Patients who receive prenatal care at Christiana Care may be approached if an induction of labor is scheduled and consented at their prenatal visit. All indications for induction will be included except those specifically mentioned as exclusion criteria. Any contraindication for vaginal delivery would exclude the subject. After informed consent is obtained, the Foley catheter will be placed and the subject will be randomized to receive oxytocin (study group) or not (control group). After Foley catheter removal or expulsion, the remainder of the induction course was left to the discretion of the primary provider. Prior to randomization, the subject will be placed into the nulliparous or multiparous group.

Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn
Being tested: Oxytocin, Transcervical Foley catheter
Keywords: induction, Foley catheter, oxytocin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxytocinDrug
Transcervical Foley catheterDevice
Also called Transcervical Foley balloon

Study groups in NCT02273115
Study group	Role	What they receive
Nulliparous - Foley only	Active comparator	Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Receives: Device: Transcervical Foley catheter
Nulliparous - Foley and oxytocin	Active comparator	Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Receives: Drug: Oxytocin; Device: Transcervical Foley catheter
Multi(primi)parous - Foley only	Active comparator	Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal. Receives: Device: Transcervical Foley catheter
Multi(primi)parous - Foley and oxytocin	Active comparator	Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement. Receives: Drug: Oxytocin; Device: Transcervical Foley catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Delivery Rate
The rate of women who deliver in less than or equal to 24 hours from Foley placement.
Measured: Within 24 hours

Secondary outcomes (8)

Number of Participants With Time to Delivery Achieved Within 12 Hours
Number of participants with a time from Foley placement to delivery less than or equal to 12 hours
Measured: Within 12 hours
Total Time to Delivery
Measured: On average, 24-36 hours
Time to Foley Expulsion
Measured: 0-12 hours
Number of Vaginal Deliveries
Measured: Assessed after delivery, on average occurring between 24-48 hours
Regional Analgesia
Regional analgesia used during Foley ripening
Measured: Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours
Obstetric Complications
Measured: Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period
Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7
Measured: Assessed from birth through discharge, on average 2 days after birth
Neonatal Outcome: Neonatal Weight
Measured: Assessed from birth through discharge, on average 2 days after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201411 Sep 2016

First posted23 Oct 2014 (estimated)
Study startOct 2014
Primary completion11 Sep 2016
Study completion11 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Labor; Forced or Induced, Affecting Fetus or NewbornStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02273115
Sponsor's protocol ID: CCC-34107
Acronym: NOFOX
Status last verified: Jun 2017
First submitted: 20 Oct 2014
Last updated: 2 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Bujold E, Blackwell SC, Gauthier RJ. Cervical ripening with transcervical foley catheter and the risk of uterine rupture. Obstet Gynecol. 2004 Jan;103(1):18-23. doi: 10.1097/01.AOG.0000109148.23082.C1.
PubMed 14704239
Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
PubMed 23303106
Cromi A, Ghezzi F, Agosti M, Serati M, Uccella S, Arlant V, Bolis P. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011 Apr;204(4):338.e1-7. doi: 10.1016/j.ajog.2010.11.029. Epub 2011 Jan 26.
PubMed 21272849
Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.
PubMed 20502296
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
Kashanian M, Nazemi M, Malakzadegan A. Comparison of 30-mL and 80-mL Foley catheter balloons and oxytocin for preinduction cervical ripening. Int J Gynaecol Obstet. 2009 May;105(2):174-5. doi: 10.1016/j.ijgo.2009.01.005. Epub 2009 Feb 20. No abstract available.
PubMed 19232606
Levy R, Kanengiser B, Furman B, Ben Arie A, Brown D, Hagay ZJ. A randomized trial comparing a 30-mL and an 80-mL Foley catheter balloon for preinduction cervical ripening. Am J Obstet Gynecol. 2004 Nov;191(5):1632-6. doi: 10.1016/j.ajog.2004.03.033.
PubMed 15547534
Moraes Filho OB, Albuquerque RM, Cecatti JG. A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction. Acta Obstet Gynecol Scand. 2010 Aug;89(8):1045-52. doi: 10.3109/00016349.2010.499447.
PubMed 20636243
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
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.
PubMed 36996264
Gagnon J, Corlin T, Berghella V, Hoffman MK, Sciscione A, Marie PS, Schoen CN. Intracervical Foley catheter with and without oxytocin for labor induction with Bishop score </=3: a secondary analysis. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100350. doi: 10.1016/j.ajogmf.2021.100350. Epub 2021 Mar 20.
PubMed 33757937
Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032.
PubMed 28486381

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor (NOFOX): a Randomized Control Trial
ClinicalTrials.gov ID: NCT02273115
Acronym / sponsor ID: NOFOX / CCC-34107
Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn
Keywords: induction, Foley catheter, oxytocin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Christiana Care Health ServicesUniversity, hospital or other
Collaborators: Thomas Jefferson University
Study start: Oct 2014
Primary completion: 11 Sep 2016 (actual)
Study completion: 11 Sep 2016 (actual)
First posted: 23 Oct 2014 (estimated)
Results: Posted 5 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Nulliparous - Foley only	Active comparator	Device: Transcervical Foley catheterNulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Nulliparous - Foley and oxytocin	Active comparator	Drug: Oxytocin, Device: Transcervical Foley catheterNulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Multi(primi)parous - Foley only	Active comparator	Device: Transcervical Foley catheterMultiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Multi(primi)parous - Foley and oxytocin	Active comparator	Drug: Oxytocin, Device: Transcervical Foley catheterMultiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age greater than 18 years
Pregnant, singleton gestation, vertex presentation
Admitted for induction of labor between gestational ages 24 - 42 weeks
Bishop score <6

Key exclusion criteria (15 listed)

Multiple gestation
Non-vertex presentation
Latex allergy or latex-free Foley catheter to be placed
Fetal death
Anomalous fetus

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxytocin	Drug	Multi(primi)parous - Foley and oxytocin, Nulliparous - Foley and oxytocin
Transcervical Foley catheterAlso: Transcervical Foley balloon	Device	Multi(primi)parous - Foley and oxytocin, Multi(primi)parous - Foley only, Nulliparous - Foley and oxytocin, Nulliparous - Foley only

Primary outcome

Delivery Rate
Time frame: Within 24 hours
The rate of women who deliver in less than or equal to 24 hours from Foley placement.

8 secondary outcomes

Number of Participants With Time to Delivery Achieved Within 12 Hours
Time frame: Within 12 hours
Total Time to Delivery
Time frame: On average, 24-36 hours
Time to Foley Expulsion
Time frame: 0-12 hours
Number of Vaginal Deliveries
Time frame: Assessed after delivery, on average occurring between 24-48 hours
Regional Analgesia
Time frame: Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours
Obstetric Complications
Time frame: Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period
Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7
Time frame: Assessed from birth through discharge, on average 2 days after birth
Neonatal Outcome: Neonatal Weight
Time frame: Assessed from birth through discharge, on average 2 days after birth

Results and safety

Results posted to the registry on 5 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nulliparous - Foley Only	94	94
Nulliparous - Foley and Oxytocin	90	90
Multi(Primi)Parous - Foley Only	67	67
Multi(Primi)Parous - Foley and Oxytocin	72	71

Primary outcome: Delivery Rate

Time frame: Within 24 hours. Count of participants. Unit: Participants

Measure	Nulliparous - Foley Only n = 94	Nulliparous - Foley and Oxytocin n = 90	Multi(Primi)Parous - Foley Only n = 67	Multi(Primi)Parous - Foley and Oxytocin n = 71
Value	40	58	48	62

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nulliparous - Foley Only	0 of 94 (0%)	1 of 94 (1.1%)	0 of 94
Nulliparous - Foley and Oxytocin	0 of 90 (0%)	0 of 90 (0%)	0 of 90
Multi(Primi)Parous - Foley Only	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Multi(Primi)Parous - Foley and Oxytocin	0 of 71 (0%)	1 of 71 (1.4%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14704239Bujold E, Blackwell SC, Gauthier RJ. Cervical ripening with transcervical foley catheter and the risk of uterine rupture. Obstet Gynecol. 2004 Jan;103(1):18-23. doi: 10.1097/01.AOG.0000109148.23082.C1.
Background: PubMed 23303106Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
Background: PubMed 21272849Cromi A, Ghezzi F, Agosti M, Serati M, Uccella S, Arlant V, Bolis P. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011 Apr;204(4):338.e1-7. doi: 10.1016/j.ajog.2010.11.029. Epub 2011 Jan 26.
Background: PubMed 20502296Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.
Background: PubMed 21793769Fitzpatrick 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.
Background: PubMed 19232606Kashanian M, Nazemi M, Malakzadegan A. Comparison of 30-mL and 80-mL Foley catheter balloons and oxytocin for preinduction cervical ripening. Int J Gynaecol Obstet. 2009 May;105(2):174-5. doi: 10.1016/j.ijgo.2009.01.005. Epub 2009 Feb 20. No abstract available.
Background: PubMed 15547534Levy R, Kanengiser B, Furman B, Ben Arie A, Brown D, Hagay ZJ. A randomized trial comparing a 30-mL and an 80-mL Foley catheter balloon for preinduction cervical ripening. Am J Obstet Gynecol. 2004 Nov;191(5):1632-6. doi: 10.1016/j.ajog.2004.03.033.
Background: PubMed 20636243Moraes Filho OB, Albuquerque RM, Cecatti JG. A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction. Acta Obstet Gynecol Scand. 2010 Aug;89(8):1045-52. doi: 10.3109/00016349.2010.499447.
Background: PubMed 18515515Pettker 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.
Derived from this study: PubMed 36996264de 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.
Derived from this study: PubMed 33757937Gagnon J, Corlin T, Berghella V, Hoffman MK, Sciscione A, Marie PS, Schoen CN. Intracervical Foley catheter with and without oxytocin for labor induction with Bishop score </=3: a secondary analysis. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100350. doi: 10.1016/j.ajogmf.2021.100350. Epub 2021 Mar 20.
Derived from this study: PubMed 28486381Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Corina Schoen, MD principal investigator

Sidney Kimmel Medical College at Thomas Jefferson University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delivery Rate (time frame: Within 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02273115, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.