Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT02150954Other idPro00001312

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 121 participants (actual)
Sponsor: Duke University · Other
Design: Randomized · Open label (no masking)
Countries: Not stated
Start: Dec 2007
Primary completion: Mar 2009
Completion: Mar 2009
First posted: 30 May 2014 (estimated)
Last update posted: 26 Oct 2023
Conditions: Induction of Labor

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2007200820092010

Ph 4
Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor
NCT02150954
Dec 2007 to Mar 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

pitocinDrug

Arms2

Active comparator
foley bulb induction with low dose pitocin
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.
Active comparator
foley bulb with standard incremental pitocin infusion protocol
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.

Primary outcomes2

Outcomes the sponsor listed as primary.

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)
Registry description
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)
Registry description
Time from foley balloon placement until neonate delivery

Secondary outcomes(7)

Rate of Cesarean Delivery
Time frame · during admission for delivery, up to approximately 4 days
Registry description
Number of participants having a cesarean delivery
Time to Active Labor
Time frame · during admission for delivery, up to approximately 4 days
Registry description
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.
Time to Foley Expulsion or Removal
Time frame · foley bulb placement until removal, up to 10 hours
Registry description
Time from foley balloon placement until the expulsion or removal of the foley balloon.
Incidence of Uterine Hyperstimulation
Time frame · during admission for delivery, up to approximately 4 days
Registry description
Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.
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
Registry description
number of participants with placental abruption
Neonatal Outcome: Late Fetal Heart Rate Decelerations
Time frame · during admission for delivery, up to approximately 4 days
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)

Time to the Second Stage of Labor

Group	Value (hours)
Foley Bulb Induction With Low Dose Pitocin	18.2
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	14.6

Primary outcomeMedian· foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)

Time to Delivery

Group	Value (hours)
Foley Bulb Induction With Low Dose Pitocin	23.7
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	19.1

Secondary and other outcome results(6)

Secondary outcomeNumber· during admission for delivery, up to approximately 4 days

Rate of Cesarean Delivery

Group	Value (participants)
Foley Bulb Induction With Low Dose Pitocin	22
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	20

Secondary outcomeMedian· during admission for delivery, up to approximately 4 days

Time to Active Labor

Group	Value (hours)
Foley Bulb Induction With Low Dose Pitocin	9.3
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	12.2

Secondary outcomeMedian· foley bulb placement until removal, up to 10 hours

Time to Foley Expulsion or Removal

Group	Value (hours)
Foley Bulb Induction With Low Dose Pitocin	4.5
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	5.6

Secondary outcomeNumber· during admission for delivery, up to approximately 4 days

Incidence of Uterine Hyperstimulation

Group	Value (participants)
Foley Bulb Induction With Low Dose Pitocin	7
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	11

Secondary outcomeMean· at time of birth (0 to 1 hour)

Neonatal Outcome: Birthweight

Group	Value (gram)	Spread
Foley Bulb Induction With Low Dose Pitocin	3065	530
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	3180	511

Secondary outcomeNumber· during admission for delivery, up to approximately 4 days

Neonatal Outcome: Placental Abruption

Group	Value (participants)
Foley Bulb Induction With Low Dose Pitocin	0
Foley Bulb With Standard Incremental Pitocin Infusion Protocol	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Foley Bulb Induction With Low Dose 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. pitocin	–	0 / 57	0 / 57
Foley Bulb With Standard Incremental Pitocin Infusion ProtocolSubjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min. pitocin	–	0 / 59	0 / 59

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Patients with a singleton pregnancy 2. Term pregnancy (\> 37 weeks gestation) 3. Age ≥ 18 years 4. Bishop score \< 5 5. Contractions \< 6/hr 6. Reassuring fetal heart tracing Exclusion Criteria: 1. Rupture of membranes 2. Antepartum bleeding 3. Fetal death 4. Placenta previa or low lying placenta 5. Active genital herpes infection 6. Previous use of an induction or preinduction agent during the current pregnancy 7. EFW \>4500 grams 8. Non reassuring fetal testing 9. Inability to pass foley through cervix 10. Prior cesarean section

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