Pregnancy RelatedOFFSITE IINCT03472937
Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women
A study testing Transcervical Foley catheter placement for cervical ripening in people with Pregnancy Related, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Transcervical Foley catheter placement for cervical ripening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2018to 13 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Nulliparous
- Singleton gestation
- Gestational age between 39+0 and 42+0 weeks
- Vertex presentation
- Modified Bishop score <5 and cervical dilation ≤ 2 cm
Show all 10Show fewer
- No prior cesarean or prior uterine surgery
- Resides within 30 minutes of UAB Hospital
- Access to a telephone
- Reliable transportation
Who cannot join
- Unsuitable for outpatient cervical ripening (e.g., IUGR, oligohydramnios, polyhydramnios, gestational hypertension or preeclampsia, complex maternal disease, provider discretion). Patients with well controlled Class A or B DM or chronic hypertension will be eligible.
- Latex allergy
- Contraindication to induction of labor
- Evidence of labor
- Fetal demise
- Fetal anomaly
- Inability to give consent (e.g., inability to read or write)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study
The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).
Read the detailed description
Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to "ready" the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery.
Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own home.
The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge from the hospital.
- Conditions
- Pregnancy Related
- Being tested
- Transcervical Foley catheter placement for cervical ripening
- Keywords
- Mechanical cervical ripening, Transcervical catheter, Foley catheter for labor induction, Cervical ripening, Induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical Foley catheter placement for cervical ripeningProcedure or surgery
Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient cervical ripening group | Active comparator | Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter. Receives: Procedure: Transcervical Foley catheter placement for cervical ripening |
| Outpatient cervical ripening group | Active comparator | Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (intervention arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next day to be admitted to labor and delivery for induction of labor with oxytocin. Receives: Procedure: Transcervical Foley catheter placement for cervical ripening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time from admission to delivery
Measured: From baseline to the time of delivery (baseline is from admission)
Secondary outcomes (24)
Modified Bishop score on admission
Measured: At baseline
Evaluation of patient satisfaction with care
Assessed through survey adapted from "Six Simple Questions Survey," which has been published by Harvey et al (Harvey et al. Evaluation of satisfaction with midwifery care. Midwifery. 2002 Dec; 18(4):260-7.) This survey has 6 questions to assess perceptions of satisfaction with care. The questions include questions such as, "I had appropriate and adequate control over my care," "The person(s) responsible for my care are/were caring and compassionate," and "Problems that have arisen up to now have not been dealt with effectively." The scare ranges from 1-7, with 1 representing Strongly Disagree and 7 representing Strongly Agree.
Measured: Within 2-4 days after delivery
Evaluation of patient experience on labor and delivery
Assessed through survey adapted from "Labor and Delivery Index (LADY-X" Survey, which has been published by Gartner et al (Gartner et al. Calculating Preference Weights for the Labor and Delivery Index: A Discrete Choice Experiment on Women's Birth Experiences. Value Health. 2015 Sep; 18(6):856-864.) This survey has 7 questions to assess experiences during labor and birth. Each question then has 3 answer choices that describe how good/poor the experience was. An example of a question is, "Taking your wishes seriously during childbirth." The answers then include "very seriously, sufficiently seriously, or insufficiently seriously."
Measured: Within 2-4 days after delivery
Evaluation of pain experienced during childbirth
Assessed through survey that contains 4 questions. The first 3 questions assess pain (worst pain during labor, overall pain during labor, and worse pain during placement of the Foley balloon). The 4th question asks how likely a patient is to recommend her method of induction to a friend/family member. The scale ranges from 0-100, with 0 representing no pain or very unlikely and 100 representing pain as bad as it could possibly be or very likely. The patient is instructed to place a hash mark over the line.
Measured: From placement of Foley bulb to delivery
Vaginal bleeding greater than bloody show
Vaginal bleeding that is like a period or more
Measured: From placement of Foley bulb to delivery
Total hospital duration
Measured: From hospital admission to hospital discharge (generally less than one week)
Rates of acetaminophen use
Measured: From placement of Foley bulb to 24 hours
Rates of calls to the obstetrical triage unit
Measured: From placement of Foley bulb to 24 hours
Early admission or early visit to the obstetrical triage unit prior to scheduled induction of labor time
Measured: From placement of Foley bulb to 24 hours
Rates of spontaneous rupture of membranes between Foley bulb placement and admission
Measured: From placement of Foley bulb to 24 hours
Non-reassuring fetal heart rate tracings 30-minutes after Foley bulb placement
Measured: From placement of Foley bulb to 30 minutes
Total duration of time of neuraxial anesthesia use
Measured: From baseline to delivery
Total time of oxytocin infusion
Measured: From baseline to delivery
Maximum oxytocin rate
Measured: From baseline to delivery
Highest maternal intrapartum temperature
Measured: From baseline to delivery
Rates of chorioamnionitis
Measured: From baseline to delivery
Rates of endometritis
Measured: From delivery until 30 days post-discharge
Mode of delivery
Rates of vaginal delivery, cesarean delivery, and operative vaginal delivery (vacuum or forceps)
Measured: From baseline to delivery
Postpartum hemorrhage
Measured: At delivery
Rates of hospital readmission within 30 days
Measured: From hospital discharge until 30 days post-discharge
Rates of 5-minute Apgar score <7
Measured: From time of delivery up to 5 minutes post-delivery
Rates of umbilical cord artery pH <7.1
Measured: From time of delivery up to 5 minutes post-delivery
Rates of umbilical cord artery base deficit <-12
Measured: From time of delivery up to 5 minutes post-delivery
Rates of neonatal intensive care unit admissions
Measured: After delivery and before neonatal discharge (generally less than one week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start4 May 2018
- Primary completion1 Nov 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth B. Ausbeck, University of Alabama at Birmingham
- Investigators
- Elizabeth B Ausbeck, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472937
- Sponsor's protocol ID
- F9999999
- Acronym
- OFFSITE II
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 19623003Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.
PubMed 24222365Amorosa JM, Stone JL. Outpatient cervical ripening. Semin Perinatol. 2015 Oct;39(6):488-94. doi: 10.1053/j.semperi.2015.07.014. Epub 2015 Sep 11.
PubMed 26365009O'Brien JM, Mercer BM, Cleary NT, Sibai BM. Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 1995 Dec;173(6):1855-9. doi: 10.1016/0002-9378(95)90440-9.
PubMed 8610775Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
PubMed 11704164McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol. 1999 Jul;94(1):11-4. doi: 10.1016/s0029-7844(99)00244-6.
PubMed 10389710Rayburn W, Gosen R, Ramadei C, Woods R, Scott J Jr. Outpatient cervical ripening with prostaglandin E2 gel in uncomplicated postdate pregnancies. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1417-23. doi: 10.1016/0002-9378(88)90376-6.
PubMed 3289398Sawai SK, O'Brien WF, Mastrogiannis DS, Krammer J, Mastry MG, Porter GW. Patient-administered outpatient intravaginal prostaglandin E2 suppositories in post-date pregnancies: a double-blind, randomized, placebo-controlled study. Obstet Gynecol. 1994 Nov;84(5):807-10.
PubMed 7936516Biem SR, Turnell RW, Olatunbosun O, Tauh M, Biem HJ. A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction. J Obstet Gynaecol Can. 2003 Jan;25(1):23-31. doi: 10.1016/s1701-2163(16)31079-9.
PubMed 12548322Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.
PubMed 24824157Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
PubMed 22419277Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2.
PubMed 20687092Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
PubMed 24347259Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
PubMed 23356673Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
PubMed 32852803
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study
- ClinicalTrials.gov ID
- NCT03472937
- Acronym / sponsor ID
- OFFSITE II / F9999999
- Conditions
- Pregnancy Related
- Keywords
- Mechanical cervical ripening, Transcervical catheter, Foley catheter for labor induction, Cervical ripening, Induction of labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).
Detailed description
Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to "ready" the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery.
Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own home.
The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient cervical ripening group | Active comparator | Procedure: Transcervical Foley catheter placement for cervical ripeningSubjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter. |
| Outpatient cervical ripening group | Active comparator | Procedure: Transcervical Foley catheter placement for cervical ripeningSubjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (intervention arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next day to be admitted to labor and delivery for induction of labor with oxytocin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18
- Nulliparous
- Singleton gestation
- Gestational age between 39+0 and 42+0 weeks
- Vertex presentation
Key exclusion criteria (7 listed)
- Unsuitable for outpatient cervical ripening (e.g., IUGR, oligohydramnios, polyhydramnios, gestational hypertension or preeclampsia, complex maternal disease, provider discretion). Patients with well controlled Class A or B DM or chronic hypertension will be eligible.
- Latex allergy
- Contraindication to induction of labor
- Evidence of labor
- Fetal demise
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 |
|---|---|---|
| Transcervical Foley catheter placement for cervical ripeningSubjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting. | Procedure or surgery | Inpatient cervical ripening group, Outpatient cervical ripening group |
Primary outcome
Total time from admission to delivery
Time frame: From baseline to the time of delivery (baseline is from admission)
24 secondary outcomes
Modified Bishop score on admission
Time frame: At baseline
Evaluation of patient satisfaction with care
Time frame: Within 2-4 days after delivery
Evaluation of patient experience on labor and delivery
Time frame: Within 2-4 days after delivery
Evaluation of pain experienced during childbirth
Time frame: From placement of Foley bulb to delivery
Vaginal bleeding greater than bloody show
Time frame: From placement of Foley bulb to delivery
Total hospital duration
Time frame: From hospital admission to hospital discharge (generally less than one week)
Rates of acetaminophen use
Time frame: From placement of Foley bulb to 24 hours
Rates of calls to the obstetrical triage unit
Time frame: From placement of Foley bulb to 24 hours
Early admission or early visit to the obstetrical triage unit prior to scheduled induction of labor time
Time frame: From placement of Foley bulb to 24 hours
Rates of spontaneous rupture of membranes between Foley bulb placement and admission
Time frame: From placement of Foley bulb to 24 hours
Non-reassuring fetal heart rate tracings 30-minutes after Foley bulb placement
Time frame: From placement of Foley bulb to 30 minutes
Total duration of time of neuraxial anesthesia use
Time frame: From baseline to delivery
Total time of oxytocin infusion
Time frame: From baseline to delivery
Maximum oxytocin rate
Time frame: From baseline to delivery
Highest maternal intrapartum temperature
Time frame: From baseline to delivery
Rates of chorioamnionitis
Time frame: From baseline to delivery
Rates of endometritis
Time frame: From delivery until 30 days post-discharge
Mode of delivery
Time frame: From baseline to delivery
Postpartum hemorrhage
Time frame: At delivery
Rates of hospital readmission within 30 days
Time frame: From hospital discharge until 30 days post-discharge
Rates of 5-minute Apgar score <7
Time frame: From time of delivery up to 5 minutes post-delivery
Rates of umbilical cord artery pH <7.1
Time frame: From time of delivery up to 5 minutes post-delivery
Rates of umbilical cord artery base deficit <-12
Time frame: From time of delivery up to 5 minutes post-delivery
Rates of neonatal intensive care unit admissions
Time frame: After delivery and before neonatal discharge (generally less than one week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Background: PubMed 19623003ACOG 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.
- Background: PubMed 24222365Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.
- Background: PubMed 26365009Amorosa JM, Stone JL. Outpatient cervical ripening. Semin Perinatol. 2015 Oct;39(6):488-94. doi: 10.1053/j.semperi.2015.07.014. Epub 2015 Sep 11.
- Background: PubMed 8610775O'Brien JM, Mercer BM, Cleary NT, Sibai BM. Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 1995 Dec;173(6):1855-9. doi: 10.1016/0002-9378(95)90440-9.
- Background: PubMed 11704164Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
- Background: PubMed 10389710McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol. 1999 Jul;94(1):11-4. doi: 10.1016/s0029-7844(99)00244-6.
- Background: PubMed 3289398Rayburn W, Gosen R, Ramadei C, Woods R, Scott J Jr. Outpatient cervical ripening with prostaglandin E2 gel in uncomplicated postdate pregnancies. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1417-23. doi: 10.1016/0002-9378(88)90376-6.
- Background: PubMed 7936516Sawai SK, O'Brien WF, Mastrogiannis DS, Krammer J, Mastry MG, Porter GW. Patient-administered outpatient intravaginal prostaglandin E2 suppositories in post-date pregnancies: a double-blind, randomized, placebo-controlled study. Obstet Gynecol. 1994 Nov;84(5):807-10.
- Background: PubMed 12548322Biem SR, Turnell RW, Olatunbosun O, Tauh M, Biem HJ. A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction. J Obstet Gynaecol Can. 2003 Jan;25(1):23-31. doi: 10.1016/s1701-2163(16)31079-9.
- Background: PubMed 24824157Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.
- Background: PubMed 22419277Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- Background: PubMed 20687092Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2.
- WHO Recommendations for Induction of LabourLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Elizabeth B Ausbeck, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcervical Foley catheter placement for cervical ripening in people with Pregnancy Related, run by University of Alabama at Birmingham at 1 site in United States.
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 10 inclusion and 7 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 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total time from admission to delivery (time frame: From baseline to the time of delivery (baseline is from admission)). 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 NCT03472937, which also lists 16 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 6 Feb 2020.