Induction of LaborPhase 1NCT02098421
Foley Labor Induction Trial at Term and in PROM
A Phase 1 study testing Oxytocin in people with Induction of Labor, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. 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
- Induction of Labor
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to 18 Apr 2016
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women at > 24 weeks gestation
- a non-anomalous, singleton fetus in a vertex presentation
Who cannot join
- history of prior uterine surgery such as cesarean section or myomectomy
- unexplained vaginal bleeding
- latex allergy
- contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Elmhurst Hospital Center
Elmhurst, New York, 11373
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.
Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.
After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).
Read the detailed description
Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk.
- Conditions
- Induction of Labor
- Being tested
- Oxytocin
- Keywords
- Induction of Labor, Pitocin, Oxytocin, Foley bulb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Use of oxytocin while the Foley bulb is in place
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No oxytocin while the Foley bulb is in place |
| Oxytocin | Experimental | Use of oxytocin while the Foley bulb is in place Receives: Drug: Oxytocin |
| PROMS Foley and oxytocin | Experimental | Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed. Receives: Drug: Oxytocin |
| PROMS no Foley bulb | No intervention | Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb. |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction time to delivery
The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.
Measured: Time from induction to delivery, average 12-28 hours
Secondary outcomes (5)
Mode of delivery
The mode of delivery is ascertained from the delivery summary as either spontaneous vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, or forcep assisted vaginal delivery.
Measured: average of 12-28 hours from induction until official time of birth
estimated blood loss
Measured: average of 12-28 hours from induction until official time of birth
uterine atony
uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart.
Measured: average of 12-28 hours from induction until official time of birth
chorioamnionitis
Chorioamnionitis is ascertained from provider report as fever with either maternal/fetal tachycardia, fundal tenderness, or foul smelling fluid while the patient is in labor.
Measured: average of 12-28 hours from induction until official time of birth
neonatal birthweight
Measured: average of 12-28 hours from induction until official time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startNov 2014
- Primary completion18 Apr 2016
- Study completion18 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Bianco, Icahn School of Medicine at Mount Sinai
- Investigators
- Angela Bianco, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098421
- Sponsor's protocol ID
- GCO 13-1279
- Status last verified
- Jun 2017
- First submitted
- 13 Mar 2014
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Connolly KA, Kohari KS, Factor SH, Rekawek P, Miller MR, Smilen BS, Stone JL, Bianco AT. A Randomized Trial of Foley Balloon Induction of Labor Trial in Multiparas (FIAT-M). Am J Perinatol. 2017 Sep;34(11):1108-1114. doi: 10.1055/s-0037-1603994. Epub 2017 Jun 26. No abstract available.
PubMed 28651258
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
- ClinicalTrials.gov ID
- NCT02098421
- Acronym / sponsor ID
- GCO 13-1279
- Conditions
- Induction of Labor
- Keywords
- Induction of Labor, Pitocin, Oxytocin, Foley bulb
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 18 Apr 2016 (actual)
- Study completion
- 18 Apr 2016 (actual)
- First posted
- 28 Mar 2014 (estimated)
- 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.
This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.
Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.
After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).
Detailed description
Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No oxytocin while the Foley bulb is in place |
| Oxytocin | Experimental | Drug: OxytocinUse of oxytocin while the Foley bulb is in place |
| PROMS Foley and oxytocin | Experimental | Drug: OxytocinSubjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed. |
| PROMS no Foley bulb | No intervention | –Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women at > 24 weeks gestation
- a non-anomalous, singleton fetus in a vertex presentation
Key exclusion criteria (4 listed)
- history of prior uterine surgery such as cesarean section or myomectomy
- unexplained vaginal bleeding
- latex allergy
- contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)
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 |
|---|---|---|
| OxytocinAlso: PitocinUse of oxytocin while the Foley bulb is in place | Drug | Oxytocin, PROMS Foley and oxytocin |
Primary outcome
induction time to delivery
Time frame: Time from induction to delivery, average 12-28 hours
The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.
5 secondary outcomes
Mode of delivery
Time frame: average of 12-28 hours from induction until official time of birth
estimated blood loss
Time frame: average of 12-28 hours from induction until official time of birth
uterine atony
Time frame: average of 12-28 hours from induction until official time of birth
chorioamnionitis
Time frame: average of 12-28 hours from induction until official time of birth
neonatal birthweight
Time frame: average of 12-28 hours from induction until official time of birth
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 12 Jun 2017.
- Derived from this study: PubMed 28651258Connolly KA, Kohari KS, Factor SH, Rekawek P, Miller MR, Smilen BS, Stone JL, Bianco AT. A Randomized Trial of Foley Balloon Induction of Labor Trial in Multiparas (FIAT-M). Am J Perinatol. 2017 Sep;34(11):1108-1114. doi: 10.1055/s-0037-1603994. Epub 2017 Jun 26. No abstract available.
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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.
Angela Bianco, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Induction of Labor, run by Icahn School of Medicine at Mount Sinai at 2 sites 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 2 inclusion and 4 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 12 Jun 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
induction time to delivery (time frame: Time from induction to delivery, average 12-28 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 NCT02098421, which also lists 1 linked publication.
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 12 Jun 2017.