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Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction

Randomized Trial of Transcervical Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00442663
Acronym
FOLEYEASI
Enrollment
170
Registered
2007-03-02
Start date
2003-06-30
Completion date
2005-12-31
Last updated
2007-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Ripening, Labor Induction

Keywords

Labor Induction, Cervical Ripening, Foley Catheter

Brief summary

The purpose of this study is to compare the efficacy of a transcervical Foley catheter with and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.

Detailed description

In the United States, labor inductions have increased from 11% of all pregnancies in 1989 to 21% in 2004. Although the indications for labor induction vary, labor inductions as an obstetrical practice are associated with an increased risk of Cesarean delivery. As such, the rise in labor inductions has been paralleled by a rise in the cesarean rate to an all time high of 30%. The risk of cesarean can be mitigated with the use of cervical ripening agents in the setting of an unfavorable cervix. Both pharmacological ripening agents and mechanical methods are currently available for cervical priming. Methods available for mechanical dilation include, but are not limited to transcervical foley catheter alone and transcervical foley catheter with an extra-amniotic saline infusion or EASI. The potential advantage of EASI to transcervical foley catheter alone is the promotion of endogenous prostaglandin release by membrane stripping and supplying additional mechanical force. It may be disadvantageous by increasing the risk of chorioamnionitis or by diluting the prostaglandins that are released by membrane stripping. There have been two randomized trials comparing foley alone to foley with EASI. Because the results of these two trials are conflicting, we chose to conduct a randomized clinical trial of foley catheter compared to foley catheter with an EASI for labor induction and cervical ripening in women with an unfavorable cervix.

Interventions

DEVICETranscervical Foley Catheter with an EASI

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Singleton pregnancy * 24-42 weeks of gestation * Cephalic presentation * Intact membranes * Bishop score of less than or equal to 6

Exclusion criteria

* Contraindications to labor * Dead or severely anomalous fetus * Spontaneous labor.

Design outcomes

Primary

MeasureTime frame
Time from the start of labor induction to delivery

Secondary

MeasureTime frame
Secondary maternal outcomes included cesarean delivery, chorioamnionitis and endometritis. Neonatal outcomes included birthweight, Apgar scores and cord blood gas analysis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026