Induction of LaborPhase 4NCT02150954

Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

A Phase 4 study testing pitocin in people with Induction of Labor, run by Duke University.

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

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Induction of Labor
What is being tested?: pitocin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: No sites listed yet
Study dates: Dec 2007to Mar 2009
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a singleton pregnancy
Term pregnancy (> 37 weeks gestation)
Age ≥ 18 years
Bishop score < 5
Contractions < 6/hr
Reassuring fetal heart tracing

Who cannot join

Rupture of membranes
Antepartum bleeding
Fetal death
Placenta previa or low lying placenta
Active genital herpes infection
Previous use of an induction or preinduction agent during the current pregnancy

Show all 10Show fewer

EFW >4500 grams
Non reassuring fetal testing
Inability to pass foley through cervix
Prior cesarean section

About this study

Official title: A Randomized Comparison of Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.

Conditions: Induction of Labor
Being tested: pitocin
Keywords: induction of labor, pitocin, foley bulb

What participants receive

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

pitocinDrug
Also called oxytocin

Study groups in NCT02150954
Study group	Role	What they receive
foley bulb induction with low dose pitocin	Active comparator	Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes. Receives: Drug: pitocin
foley bulb with standard incremental pitocin infusion protocol	Active comparator	Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min. Receives: Drug: pitocin

What is being measured

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

Time to the Second Stage of Labor
The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.
Measured: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)
Time to Delivery
Time from foley balloon placement until neonate delivery
Measured: foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)

Secondary outcomes (7)

Rate of Cesarean Delivery
Number of participants having a cesarean delivery
Measured: during admission for delivery, up to approximately 4 days
Time to Active Labor
Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.
Measured: during admission for delivery, up to approximately 4 days
Time to Foley Expulsion or Removal
Time from foley balloon placement until the expulsion or removal of the foley balloon.
Measured: foley bulb placement until removal, up to 10 hours
Incidence of Uterine Hyperstimulation
Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.
Measured: during admission for delivery, up to approximately 4 days
Neonatal Outcome: Birthweight
Measured: at time of birth (0 to 1 hour)
Neonatal Outcome: Placental Abruption
number of participants with placental abruption
Measured: during admission for delivery, up to approximately 4 days
Neonatal Outcome: Late Fetal Heart Rate Decelerations
Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.
Measured: during admission for delivery, up to approximately 4 days

Timeline

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

Dec 2007Mar 2009

First posted30 May 2014 (estimated)
Study startDec 2007
Primary completionMar 2009
Study completionMar 2009

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.
Other trials for Induction of LaborStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02150954
Sponsor's protocol ID: Pro00001312
Status last verified: Jun 2014
First submitted: 23 May 2014
Last updated: 26 Oct 2023
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety

All Induction of Labor trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Comparison of Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor
ClinicalTrials.gov ID: NCT02150954
Acronym / sponsor ID: Pro00001312
Conditions: Induction of Labor
Keywords: induction of labor, pitocin, foley bulb
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Dec 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 30 May 2014 (estimated)
Results: Posted 23 Jul 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
foley bulb induction with low dose pitocin	Active comparator	Drug: pitocinSubjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
foley bulb with standard incremental pitocin infusion protocol	Active comparator	Drug: pitocinSubjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients with a singleton pregnancy
Term pregnancy (> 37 weeks gestation)
Age ≥ 18 years
Bishop score < 5
Contractions < 6/hr

Key exclusion criteria (10 listed)

Rupture of membranes
Antepartum bleeding
Fetal death
Placenta previa or low lying placenta
Active genital herpes infection

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
pitocinAlso: oxytocin	Drug	foley bulb induction with low dose pitocin, foley bulb with standard incremental pitocin infusion protocol

Primary outcome

Time to the Second Stage of Labor
Time frame: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)
The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.
Time to Delivery
Time frame: foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)
Time from foley balloon placement until neonate delivery

7 secondary outcomes

Rate of Cesarean Delivery
Time frame: during admission for delivery, up to approximately 4 days
Time to Active Labor
Time frame: during admission for delivery, up to approximately 4 days
Time to Foley Expulsion or Removal
Time frame: foley bulb placement until removal, up to 10 hours
Incidence of Uterine Hyperstimulation
Time frame: during admission for delivery, up to approximately 4 days
Neonatal Outcome: Birthweight
Time frame: at time of birth (0 to 1 hour)
Neonatal Outcome: Placental Abruption
Time frame: during admission for delivery, up to approximately 4 days
Neonatal Outcome: Late Fetal Heart Rate Decelerations
Time frame: during admission for delivery, up to approximately 4 days

Results and safety

Results posted to the registry on 23 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Foley Bulb Induction With Low Dose Pitocin	58	57
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	59	59

Primary outcome: Time to the Second Stage of Labor

Time frame: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days). Mean (Inter-Quartile Range). Unit: hours

Measure	Foley Bulb Induction With Low Dose Pitocin n = 57	Foley Bulb With Standard Incremental Pitocin Infusion Protocol n = 59
Value	18.2 (13.6 to 27.8)	14.6 (9.9 to 28.3)

Primary outcome: Time to Delivery

Time frame: foley bulb placement until delivery (during admission for delivery, up to approximately 4 days). Median (Inter-Quartile Range). Unit: hours

Measure	Foley Bulb Induction With Low Dose Pitocin n = 57	Foley Bulb With Standard Incremental Pitocin Infusion Protocol n = 59
Value	23.7 (13.8 to 30.1)	19.1 (12.1 to 32.1)

7 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
Foley Bulb Induction With Low Dose Pitocin	0 of 57 (0%)	0 of 57 (0%)	Not reported
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	0 of 59 (0%)	0 of 59 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Induction of Labor

Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety

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.

Chad Grotegut, MD principal investigator

Duke University

Brennan Fitzpatrick, MD principal investigator

Duke University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pitocin in people with Induction of Labor, run by Duke University.

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 6 inclusion and 10 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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 23 Jul 2014). 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?

Time to the Second Stage of Labor (time frame: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)). The study lists 2 primary outcomes in all. 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 NCT02150954.

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 26 Oct 2023.