Cervical Ripening Clinical Trial
Official title:
Randomized Controlled Trial of Prehospital Cervical Ripening With an Outpatient Transcervical Foley Balloon and the Duration of Induction and Maternal Satisfaction
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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