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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01641601
Other study ID # 12-08620
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 2012
Est. completion date July 2015

Study information

Verified date July 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized study evaluating the impact of pre-hospital cervical ripening with a transcervical Foley balloon before labor induction in full-term pregnancies on the length of inpatient labor induction and maternal satisfaction with the labor induction process. The investigators hypothesize that women who receive pre-hospital cervical ripening will have a shorter duration of inpatient labor induction as compared to women without pre-hospital cervical ripening.


Description:

Labor induction is a common procedure among pregnant patients at term. This process involves a period of cervical preparation ("ripening") for women who have an "unfavorable" cervical examination at the time labor induction is scheduled. Cervical ripening may take place with pharmacologic or mechanical strategies, which at this time are traditionally administered on an inpatient basis. This process can 24 or more hours, resulting in a lengthy hospitalization with the associated costs and frustrations for both patients and L&D staff.

The proposed study is a randomized, controlled trial to explore the following research question: Among women with full-term pregnancies requiring labor induction, does pre-hospital, outpatient cervical ripening reduce the amount of inpatient time needed to achieve delivery as compared to no pre-hospital cervical ripening? As a secondary objective, we also wish to explore if outpatient cervical ripening is acceptable to patients.

This study will involve randomizing eligible and consenting women who have been scheduled for labor induction by their obstetrical providers into a pre-hospital cervical ripening (intervention) group or a no pre-hospital ripening (control) group. A trans-cervical Foley balloon (TCFB) will be used for outpatient pre-hospital cervical ripening in women randomized to the intervention group. No pre-hospital ripening will be performed for women in the control group. Both groups will be admitted for induction as scheduled and will undergo labor induction according to a specified, Bishop-score based induction protocol, which may or may not include a TCFB. We will compare the duration of inpatient stays from admission until delivery between the groups as well as satisfaction with the pre-hospital period and labor and delivery experience. Maternal and neonatal outcomes will also be compared between the two groups.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 50 Years
Eligibility Inclusion Criteria:

- Intrauterine pregnancy

- Cephalic presentation

- Greater than 36 weeks estimated gestational age

- Reassuring fetal status

- Normal amniotic fluid index

- Clinical indication for induction of labor

Exclusion Criteria:

- Prior cesarean section

- Bishop score on cervical examination = 6

- Unreliable transportation

- Home > 30 minutes from the hospital

- Non-reassuring fetal status

- Abnormal amniotic fluid index

- Other indication for immediate hospitalization

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Outpatient transcervical Foley balloon
A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction.

Locations

Country Name City State
United States UCSF Benioff Children's Hospital San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of Inpatient Time Required to Achieve Delivery Time from admission to the hospital until delivery From admission to delivery, expected average of 48 hours
Secondary Maternal Satisfaction Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview. up to 48 hours after delivery
See also
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Completed NCT01127581 - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery Phase 3
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Active, not recruiting NCT02975167 - Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor N/A
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Completed NCT00886860 - The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol Phase 4
Recruiting NCT01156948 - Misoprostol For Nulliparous Women Before Hysteroscopy Phase 3
Completed NCT00504465 - Combined Agent Randomized Trial of Induction of Labor N/A
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Not yet recruiting NCT00815542 - Induction of Labor in Oligohydramnios Phase 3
Completed NCT01170819 - Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening. Phase 4
Completed NCT00442663 - Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction N/A